Executive Quality, Regulatory Operations Leader

SUNITA SHARMA, Ph.D.

** ******** ****** **

Catonsville, MD 21228

Tel.: 401-***-****

Primary: ***************@*******.***

LinkedIn URL: linkedin.com/in/sunita-s-1a88916

Executive Quality, Regulatory Operations, & Compliance

Executive leader with 30+ years of experience in Life-Sciences organizations (Medical Devices /Biopharmaceuticals): R&D, Clinical operations, Compliance, Regulatory Operations, Quality Management System, Manufacturing, Validation, & Audit.

Strategic thinking executive experienced in supporting corporate initiatives, Develop high performance teams, Lead a Drive for Compliance Quality Culture, Lead Cross functional Site specific, Regional and Global teams, Collaborate with Medical professionals and Business partners, Employ data-driven hands-on approach to problem solving, Decision making, Passionate in applying excellent organization and communication skills to manage and lead teams in complex projects and develop simplified solutions with value-driven leadership, Achieve low operating costs, and high profitability

Results-proven, highly effective, customer-focused Senior Executive and Leader with 30 years of biopharmaceutical, Medical Device companies. Computer System Validation, management of Quality Systems, Quality Compliance, CAPA, Investigation, and leading global Quality (QA and QC) Compliance, Internal/External Audits, Operational Excellence, Regulatory Affairs, and achieving revenue, cost, productivity and operational goals.

Strategic planning, Management of coordination and cooperation of routine (and non-routine) operations, document control, review, approval and release of product daily while maintaining compliance through all elements of the organization.

Management of direct/indirect reports

Compliance guidelines, company policies and government regulations

Global Quality (QA and QC), Regulatory and Compliance, IT

cGMP, GCP, GLP, GTP, GDP, Biologics/Pharmaceuticals, Life Sciences, Medical devices

Strong CMC experience including drug-device combination product, device development, registration and post market support

Product Operations, Integration & Supply chain

Product safety including PLM, specifications, BOM, regulatory and compliance

Product market research to enhance, develop and leverage the research methodologies to fill the gaps by designing, executing and interpreting them

Set standards and goals for the management of preclinical, all stages of clinical studies to obtain safety and efficacy data and manufacturing optimization, validation, and scale up for clinical studies and commercial launch

Documentation, Document control, SOPs, protocols, reports, Batch records

Medical device, Solid, Injectable, API manufacture, OTC submission & switch

FDA, EMEA, Canada Health, ICH, ISO, USP, GAMP 5, GMP, GLP, GCP, GDP, GTP

Product development, Processes, Systems validation

Methodology qualification and implementation; Technology transfer

Agency Inspection, Audits (In-house, CRO, CMO), Training

Deviation, CAPA, Investigation, Root Cause Analyses, OOS, OOT

SAP system management

Computer system Validation and IT support in GxP (Manufacturing, Labs, R&D, (including software/upgrade validations) environment (site specific or globally)

Bio-analytical Assay Development, and Validation (Bio-analytical Labs – Cell-immunology, Protein chemistry, Biochemistry, Microbiology, Raw Materials, Lab Support)

Bio-repository, Sample management, Raw materials

25 years of leading project management with a focus on process improvement, changes implemented, meet or exceed timelines, Program management

Technical writing SME

Management of marketing strategies, participation with marketing department on routine basis

Overseeing Lab operations, production, CLIA certification

Customer Focus, and oversee complaint management

Continual improvement and operational excellence

Consent Decree and Warning Letter Remediation

CMC Development/Review, IND, NDA, BLA, 510K, PMA

Technology transfer, CMO, CRO, Outsourcing manufacturing and/or testing

Hire and train employees, plan, assign and direct work

Labeling, Packaging, Dispensing, Shipping

PROFESSIONAL COMPETENCIES

Management of grants, finance, project budgets

Lead process improvement and harmonization efforts that promote best practices

Strong leadership, management and organizational skills; Technical Operations

Proven ability of technical skills detail oriented, efficiently work well in a team or independently

Extensive experience in writing and review

Effective communication, coordination, and cooperation

Strong writing and verbal communication

Policy/ Procedure initiate, develop, execute, implement, improve, manage, and maintain

Highly motivated, self-starter with broad biological sciences expertise

Excellent interpersonal skills while working with-multi cultural population

Excellent time management and organizational skills

Remove roadblocks and resolution of issues

Promote public health by protecting safety, quality, efficacy, and security of Life sciences, /biological products, and medical /non-medical devices, and by regulating the manufacture, marketing, and distribution of products

Professional experience

2023 –2025 Primary Care-taker for ill family members after lay-off from Texas Biomedical Research Institute. Only worked for few months here and there due to frequent trips to India to taking care of close family members (Mother & Sister) in India.

Global Director, Quality, Regulatory Operations & Compliance

Texas Biomedical Research Institute (CRO), San Antonio, TX, Oct 2019- Dec 2022

Mission: to protect and enhance the public health through the regulation of biological and related products by ensuring that all products are safe, effective, and available to those who need them

Managed the review process and associated activities used to support the nonclinical and clinical research in facilitating the regulation and review of biological products, drugs, devices and combination products throughout their life cycle

Strategy, direction and oversight of QA, QC, RA, and Compliance

Strategic and tactical direction throughout the product development & services provided

Responsible for clinical/nonclinical operations and Risk management

NDA, IND, BLA, PMA, 510K regulatory successful submission

Collaborated and aligned strategy, goals, objectives with business stakeholders

Leadership role (review, edit/finalize) for global regulatory submissions

Efficient communication (POC) with global regulatory agencies

Integrated QbD (Quality by design) program

Developed and monitored Quality System program (fit-for purpose)

Developed and monitored compliance throughout the Organization (CAPA, Deviation, Investigation and Mitigation program management)

Established continuous improvement program

Inspection Readiness program management, PAI Readiness, Mock PAI Audits

Established QA and QC management system

Developed and executed audit (internal and external) program for vendors/suppliers, 3rd party management

Quality, Safety and Accreditation

Evaluated and improved processes for PAI

Hired and trained, mentored and guided new/existing staff on compliance

Maximized output and efficiency

Hosted sponsors audits and/or FDA/Global inspection

Established and monitored GLP, GCP, GMP program (fit-for-purpose)

Educated and trained employees on compliance

Monitored and managed risk-management (identification & mitigation)

Monitored and maintained change management

Developed and established validation program

Interpreted and updated departments on regulatory guidelines

Worked cross-functionally with other directors and Principal Investigators

Maintained budget and generated revenue

Becton Dickinson and Company, San Antonio, TX, Sep 2018 – 2019

Becton Dickinson and Company, Sparks, MD, Jan 2017 – July 2018

Executive Quality, RA, & Compliance Corporate Global Consultant

Global medical technology company, advancement of medical discovery, diagnostics and the delivery of healthcare. The company provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, and support the management of diabetes.

Maintained Quality System, Managed audits (and FDA inspection), Monitored compliance for medical devices, Managed 3 PMA Amendments (Reagent Amendment, Instrument Amendment, and Software Amendment) submission for FDA Approval. “BD OnclarityTM HPV Assay receives FDA Approval for launch in the US on Feb 13, 2018”

http://www.bd.com/en-us/company/news-and-media/press-releases/feb-13-2018-fda-approves-new-hpv-test-that-detects-and-identifies-hpv-genotypes-that-put-women-at-high-risk-for-cervical-cancer

FDA Approves New HPV Test that Detects and Identifies HPV Genotypes that put Women at High Risk for Cervical Cancer

The BD Onclarity™HPV Assay can detect 14 high-risk HPV types and provide additional information to guide physician decision-making

Regulatory Affairs Strategy and Execution for molecular diagnostics

Leadership Role for strategy and FDA submissions

Pre-Market Application (PMA) Class II and III medical device Submission & Supplements & Amendments

510K Medical Device Successful Submission & Supplements & Amendments

Molecular Diagnostics Compliance

Packaging and labeling of medical devices

Class III IVD Assays & Instrumentation PMA submissions

FDA Communication (POC) on PMA & 510K Submission

Global Communication and coordination on various projects (Gap Assessment) leading regulatory submissions

Management of Technical File for current and Future EU IVDR products

Quality Management System fit for purpose

Risk Management for all PMA medical devices

Problem Solving, analytical thinking and decision making

Complaints monitoring, CAPA and investigations

Adverse events reporting

Continuous improvement

Cell/Gene therapy

Senior Global Director of QA, QC, RA, and Compliance, Personal Genome Diagnostics, Baltimore, MD, May 2015 – Dec 2016

CLIA-Certified, ICH GCP, GLP-compliant Genomics, Oncology facility

Research and Clinical Quality Services, Solutions, Regulatory, Medical Device class III devices (conception to commercialization – varieties of Cancers and rare diseases)

Quality, Safety and Accreditation

Technical and strategic direction of Quality (QA, QC) and Regulatory Operations (RA) and Compliance

Established and maintained quality management systems (SOPs, policies, procedures, regulations and guidelines) to ensure compliance with US FDA and International regulations /standards

Established processes for medical device design, development, manufacturing, packaging, labeling, shipping, stability, distribution, product launch, and commercialization

Organized and led discussions on product safety and effectiveness measurement (clinical trials)

Facilitated and supported regulatory inspections

Facilitated Quality and Compliance Culture

Managed Internal /external audits, and vendor /supplier qualifications

Maintained compliance through QC Labs, data analysis, preparation of reports, medical devices, computerized systems, policies, procedures throughout organization

Implemented and managed continuous improvement program throughout the organization

Executed computerized system validation including system and process validation needed for medical devices PMA submissions

Monitored and maintained Complaint Management, CAPA, NC, Investigations, Root Cause Analyses (RCA)

Established and managed employee performance/development of program to meet future business needs

Developed, monitored and maintained training program for compliance

Monitored and maintained safety and effectiveness of medical devices

Change Management, Risk Management, Appropriate controls throughout processes

FDA Inspection Readiness program

Regulatory PMA (and 510K) submissions for class II/III medical devices

Communicated and supported healthcare professionals

Consulted to leverage, commercialize and expand programs, capabilities and ideas for future expansion with external partners and/or contractors

Developed, led, and collaborated with cross-functional teams to facilitate operations

Hired consultant(s) to complete various projects successfully based on complete and fair scientific evaluation of applications / proposals

Prepared information for, attended panel meetings, and addressed issues and concerns about proposals pertaining to assigned program area

Cell/Gene therapy

Quality, RA Corporate Sr. Manager, Millipore Sigma, Merck KGaA (Merck Millipore), Darmstadt Germany, Jaffrey, NH, May 2013 – May 2015

FDA approved, ISO certified, cGMP Life Sciences medical and non-medical products

Develop and execute strategy and technical operations

Broad range of research, process, and applied science solutions to scientist, and researchers in the healthcare, academic and industrial sectors

Continual improvement of healthcare products for global distribution

Build high performance team and management of projects

Develop, led and complete global corporate projects successfully

Develop, and led QA, QC, Compliance programs throughout the site

Senior site management assignment leading the Computer System Validation, Quality Assurance, Quality Control, Compliance, Audit, Validation, Labeling, Disposition, CAPA, and Non-conformance functions responsible for the daily execution of the site operations.

Management of cross-functional teams, projects, planning, improvements, implementation and coordination of various site/global activities

Assist all departments in improving their performance, thereby improving the organizational performance (Operational excellence)

Administration of Quality activities including QMS, Non-conformance, CAPA, Validation & Qualification for the site and global

Computer System Validation

Documentation, SOPs, Management Procedures, Policies, Rules & Regulations

Management of Non-Conformances, CAPA

Investigation (Root Cause Analysis)

Disposition of raw material, components, finished products

Defect Analysis for root cause investigation

Risk Management, Change Management

Sample Management

Qualification, verification and validation (Computerized systems in MFG, Labs, R&D, upgrades / software validations)

Equipment and Test Method validations

Management of complaints and customer interaction

Training and career development of direct/indirect reports

Support company’s standards globally

Operational Excellence & Continuous Improvement

Identify and leverage best practices through Company’s Quality Systems

Lean Six-Sigma

Oversight of compliance with the Quality Management Program

Operations /Manufacturing, Packaging, labeling of medical devices

Management of Quality Control Laboratories

LIMS, Track-wise, EDMS, Pilgrim Software (QDS), Oracle, ManGo, SAP, LMS

Support External and Internal Auditor

Packaging, Labeling, Shipping and Distribution

Generate annual operating and capital budgets and track revenue and expenses.

Senior Consultant, Kymanox and GuidePoint Global, Apr. 2012-Apr. 2013

FDA Inspection, Inspection readiness, Site audit for Quality Management System for medical devices

Corporate global regulatory and quality management

Create, review and/or revise SOPs, policies, procedures, protocols, guidelines, reports

Management of compliance for computerized validation systems, and processes

Design and development

CAPA, NC, Investigation, RCA, Deviation

Change management

Vendor / Supplier management

Risk management, Packaging, Labeling of medical devices

Complaint management

Audit and training program

Facility management

QC Lab compliance

Quality, Safety and Accreditation

Gene Logic (CRO), Gaithersburg MD, Mar. 2011 – Apr. 2012

Director, and Global Head, RA, QA, QC, Validation, and Compliance

Acting VP, Strategic planning, Technical Operations, Project Management, Business Development

General Management:

GLP compliant and ISO certified Genomics, Proteomics, Next-Generation sequencing, LIMS and Microarray service provider

Development of Strategic Policies, and guidelines

Responsible for all quality assurance and quality control activities

Develop /Organize /Chair team and management of multiple complex projects

Management of key regulatory strategic direction and operations supporting all aspects of biological samples, production including preclinical, clinical II, III, commercial products, and devices

Led cross functional initiatives in implementation of all aspects of regulatory submission (IND, NDA, BLA, 510K, PMA)

Administration of activities of Quality organization including non-conformance, CAPA, Document control, Change control, Validation, Audits (Internal, CRO, CMO), Training, Sample management, bio-repository / bio-banking, Inspections, Security, Safety, Investigations, primary liaison with FDA.

Management of Deviations (Track wise), CAPA, Investigation

Global Quality control and quality assurance activities

Risk Assessment and management, Cost-effective programs

Master Scheduler/Control document, Change control

Implementation and validation of LIMS

Management of complaints and customer interaction

Continuous Improvement, Implementation of Best practices

Qualification, verification and validation

Management of EHS, Technology transfer

Management of RFI, RFP, RFA and SOW

Packaging, Formulation, Technology transfer, labeling, Shipping

Business Development, Revenue Enhancement

2009 – 2011 Primary Care-taker for ill family member after lay-off

Amgen, Inc., West Greenwich, RI 02817

Sr. Specialist (Sr. Manager), RA, Quality, May 2005 – Aug. 2009

Amgen is state-of-the-art biotechnology manufacturing medicines and process development in a federally regulated GMP aseptic facility.

Oversight of cGMP Bulk API and Finished product manufacturing, product release, stability, Lot release, QA, QC, validation, internal and external audits, training, Documentation, investigations, deviations, CAPA, change control, inspections, OOS, OOT, Root cause analysis, CoA, Annual product review, customer focus, Vendor qualification and management, Sample management/distribution, Master scheduling, Batch review, Continual improvement, Labeling, Formulation, Packaging, Shipping, Technology transfer, Audit CRO, CMO periodically.

Communication and coordination of global and site specific activities within Amgen for continuous improvement and operational excellence of laboratory methods, review, processes.

Interaction with Executives / Directors; collaboration within Amgen to share best practices and bring forth consistency in the quality laboratories that support commercial drug substance and drug product supply.

Quality Assurance (Biotech/Pharma):

Established quality and reliability standards by studying product and consumer requirements with other members of management and with production operators, technicians, and engineers.

Established raw material standards by studying manufacturing and engineering requirements; conferring and negotiating with suppliers; devising testing methods and procedures.

Established in-process product inspection standards by studying manufacturing methods; devising testing methods and procedures.

Established standards for the disposition of finished product by devising evaluation tests, methods, and procedures.

Established rework standards by devising inspection and physical testing methods and procedures.

Established product quality documentation system by writing and updating quality assurance procedures.

Maintained product quality by enforcing quality assurance policies and procedures and government requirements; collaborating with other members of management to develop new product and engineering designs and manufacturing and training methods.

Prepared product and process quality reports by collecting, analyzing, and summarizing information and trends.

Completed quality assurance operational requirements by scheduling and assigning employees; following up on work results.

Maintained quality assurance staff by recruiting, selecting, orienting, and training employees.

Maintained quality assurance staff job results by coaching, counseling, and disciplining employees; planning, monitoring, and appraising job results.

Maintained professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.

Achieved financial objectives by preparing the quality assurance budget; scheduling expenditures; analyzing variances; initiating corrective actions.

Contributed to team effort by accomplishing related results as needed.

Quality Assurance (for Molecular Diagnostics):

Directed and controlled quality assurance, quality system, quality control (product release and Good Laboratory Practice), and continuous process improvements addressing products and processes consistent with the needs of the organization and its stakeholders.

Orchestrated activities related to improving the quality of products/services and compliance with regulations and customer requirements worldwide.

Oversight of customer feedback, CAPA systems, and product verification & validation for functional units. ISO registration to ensure there is no lapse in quality system effectiveness.

Collaborated with personnel at all levels, across functional groups and geographic locations, including executive management, to reinforce the organization’s business processes.

Ensured quality standards are incorporated into project plans, schedules, and budgets; ensured processes are established to test and/or evaluate products and processes for compliance with applicable regulations.

Quality Control:

Responsible for short and long term goals of quality control (QC) laboratory efforts in support of IND, IMPD, NDA and commercial products and other milestones. Write CMC sections for client products. Assured finished products conform to government and company standards and satisfied GMP regulations. Reviewed and approved reports and other documentation prepared by QC for regulatory submissions/inspections.

Directed and participated with QC staff in daily operations to include release of controlled materials, receipt of testing samples, lot release, and stability testing, in-process testing, QC inspections and audits, QC test worksheets, OOS and Deviation reporting and investigations, equipment maintenance and calibration and QC laboratory design and maintenance.

Developed departmental budget for QC, including defining materials, equipment, and personnel needs.

Managed GMP Controlled Materials program to include: management of materials specifications for all XXX materials including lot released materials.

Participated in the development of, and oversees execution of, component and finished product testing (Bill of Test) and stability programs.

Wrote and reviewed QC SOPs and reviewed XXX SOPs.

Participated in developing manufacturing schedule and client Product Committee Meetings and conference calls.

Wrote client specific test qualification documents for QC execution. · Established and directed QC control programs and GMP training programs.

Managed water systems (Civic, RODI, Clean Steam, and WFI) and EM databases (Excel) for Alert Limit monitoring.

Reviewed and approved all manufacturing batch records.

RA, Quality General Management:

Oversee Quality Assurance, Quality Control

Administration of Compliance management, Technical Operations

Management of Regulatory affairs, primary liaison with FDA

Regulatory activities for product development and product release

Safety and Security assessment and improvements

Regulatory filing (IND, NDA, BLA, 510K, PMA preparation and submission)

Oversee all aspects of Quality Control functions – analytical testing, method /assay development / optimization, Technology transfer, qualification, implementation and validation, process validation, laboratory compliance, and risk assessment/management.

Plan, prioritize, organize and responsible for day to day operation of multiple laboratories (Cell Immunology, Biochemistry, Protein Chemistry, Microbiology, Raw Material, Molecular biology and Lab Support) including development and execution of several assays, protocols, standard operating procedures, data management, supervision of staff.

Expert knowledge of GMP, GLP, GTP, GCP and ISO guidelines

In-process, stability, Release material testing and review, and Disposition

Internal/External Audits, packaging, labeling of medical devices

Compliance, Risk assessment and management

FDA and EU Guidelines, ICH

Writing and review of technical reports, protocols, Standard Operating Procedures, medical briefings, articles

US Pharmacopeia (USP) guidelines for product quality and performance test and water, European Pharmacopeia (EP)

Statistical Analysis of Data (ANOVA)

Investigation, and Product Quality / Safety Program

Enterprise Document Management System (EDMS)

Laboratory Information Management System (LIMS)

Learning Management System (LMS)

Fast Start in Project Management (FSIPM)

Operational Excellence (OE)

MAXIMO

Track wise for Non-Conformance, Corrective And Preventive Action Program (CAPA)

Global Project Portfolio Management (ePPM), PERT, GANTT

Vendors/customer management

Design Of Experiments (DOE)

COGNOS

Change control Management System (CCMS)

Development and management of Validation Program

Automation of ELISA (Tecan)

Manufacturing process from inoculum to production to purification

Sample Management / Sample Repository / Bio-repository

Project Management:

Project Champion for more than 20 years of Project Management expertise with focused responsibilities for evaluation scope, objectives and goals;

Thorough understanding of financial and resources planning, coordination of project-level budget and resources;

Ability to develop and lead cross-functional teams; Assess and Manage risks, Plan, schedule, execute and close on time

Expert use of Microsoft Programs (SAP, ePPM, Gantt, PERT, COGNOS); negotiate with team members to resolve issues, Track team performance against objectives, meet or exceed timelines.

Expert knowledge of foreign clinical trial methodology, clinical auditing procedures, and drug safety data collection

Thorough Knowledge of Product Process Development, Different stages of Product Life-cycle from microscope to market, clinical trials from pre-clinical to clinical III stage and clinical IV stage activities, write, revise or edit SOPs, Protocols and Technical Reports, DOE, ANOVA, Data management and analysis,

Ability to Create, evaluate, coordinate and develop product plan, strategies and scope; Technology transfer.

Quality – Quality, Safety, Accuracy, Potency, and Efficacy of drug, device, and/or product.

Quality Management:

Quality experience in Federal Regulated Industries with an emphasis on current Good Manufacturing Practice (cGMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Quality System Regulations (QSR), International Conference on Harmonization (ICH), Human Biologics and Good Tissue Practice (GTP – Technical Lead of Cell Line Development and maintenance), as well as, ISO9000.

CMC (Quality, Development and Regulatory) and Quality Supervisory and Management experience with focused responsibilities for Quality Assurance, Quality Control, Analytical testing, Review for Bio-analytics Laboratories (Biochemistry, Protein Chemistry, Cell-immunology, Microbiology, Raw Materials, Lab Support, Sample Management), Stability and Final Product, Product Process and Program Development, Labeling, Internal/External Audits, Inspections, Document Control, Process Improvement, Regulatory Compliance, Validation, Investigations, Change Control, Training, and Corrective and Preventive action functions.

Upstream and Downstream Manufacturing – Production, Purification,

Packaging and Labeling.

Scientific Experience - Area of Cancer research, Virology, Oncology, Genetics, Cellular and molecular aspects of protein and / or protein related molecules.

National Institute of Health, Bethesda, MD Oct. 2001 – May 2005

Senior Biologist, GS-13

Experimental Transplantation & Immunology (cell therapy and gene therapy)

Supervised / guided graduate students, associates, summer students and technicians

Reviewed /wrote grants and manuscripts

Kept abreast with update literature and technologies

Attended and presented data in conferences, meetings, seminars and symposium

Principal Accomplishments:

• Zebra fish model of childhood leukemia and Ewing Sarcoma

• Use of all advanced techniques in molecular genetics, cell biology, immunohistochemistry, RNA In-situ hybridization, microarray etc.

• Mutagenesis in order to identify the additional genetic mutations

• Reviewed / wrote manuscripts, analyzed, prepared and presented data in meetings, conferences.

• Supervision of associates, technicians and summer students

GlaxoSmithKline Pharmaceuticals, King of Prussia, PA Jun. 1999 – July 2001

Senior Scientist (Lab Manager)

Quality, RA global management

Department of Immunology - Drug Discovery

Served As Lab manager

Supervised / guided graduate students, associates, summer students and technicians

Reviewed /wrote grants and manuscripts

Kept abreast with update literature and technologies

Attended and presented data in conferences, meetings, seminars and symposium

Principal Accomplishments:

• Evaluation and Characterization of TRAIL (TNF family Related Apoptosis Inducing Ligand) / Receptors as therapeutic agent for anti-cancer drug (cancer therapy). (JBC, 2000, FASEB J., 2000)

• Role of TRAIL in Rheumatoid Arthritis Vs Osteo-arthritis

• Performed cDNA microarray analysis (Clontech) to check the differential regulation

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