Summary:

Results-driven, innovative leader with expertise in QA Project/Program Management, thought leadership and mentoring skills with over 15 years of experience in Pharmaceutical, Medical Device Manufacturing/Biomedical, HealthCare, and Financial Industries.

Design and develop the QA Test from the beginning of Business Simulation Test from the Scenarios of the User stories/Requirements to Production readiness Test.

Managed System in compliance with 21 CFR 820 and ISO 13485:2016, communication with regulatory bodies, conducting audits and supporting compliant execution of quality-related processes.

Implemented and transferred of the QMS into the organization and ensuring that it is lived in everyday life.

Proficient in Resource Planning, Budgeting, Risk Management, and Successful Stakeholder Management.

Highly experienced in diverse ERP Systems (SAP, ORACLE, PEOPLESOFT, and SIEBEL etc.), Supply Chain Management, LIMS (Labware, Empower), Pharmacovigilance, Quality, and Compliance.

Led and managed Global CSV (Computer System Validation) teams ensuring compliance with GxP (cGMP, GLP, GCP and GDP) protocols, GAMP as set forth by USFDA, and international regulatory bodies (EU Annex 7, 11, EMA, MHRA, PMDA, QSR, PIC/S, ICH Q10, Eudralex Vol 4 etc.).

SME in the use of structured methodologies for certified testing including Automation Testing using various tools (QTP / UFT, SAP Solution Manager, Rational Suite etc.), Quality Assurance of Mainframe, and Distributed Environment including Cloud Based applications.

Led GxP Auditors, managed testing and validation as per FDA Regulations; CFR 21 Part 11, 203,210, 211, 218, 820, 821 and 822(a) & (b).

Effectively managed Change Controls System Requirements Analyses, Design, cGMP/ GLP Qualification Activities, Continuous Process Improvement Activities.

Conducted FMEA to assess risk and identify risk mitigation actions

Completed Annual Product Quality Reports (APQR)

Provided corporate training in CSV and End to End Testing Globally.

Worked with Global Cross functional teams to determine Product Line Readiness

Possess excellent organizational, managerial and interpersonal skills.

Experienced in project management in multi-project and multi-cultural setup.

Core Competencies:

GxP Regulation, FDA, EU, Annex, GAMP 3, 4 & 5 standards

Risk Assessment & Mitigation

Supply Chain & ERP systems – SAP ECC, WMs, Oracle EBS

Quality Systems and Standards

Computer System Validation

Project Management.

Laboratory Information Management System –(LIMS), Labware, Empower

Organization Change Management

Change Control, CAPA Follow up / Investigation / Closure, Deviation

Process Excellence

Product Quality Complain Management System

Training Management System

Document Management System (Documentum, Veeva, LiveLink)

Technical writing

End to End Test management

Defect Management

Professional Experience

American Regent Inc., Shirley, NY

Sr. Manager (QA, GxP) 11/2020 to Present

Managed the American Regent’s Quality Assurance, Quality Control and GxP activities for the New York and PA sites. Oversees GxP compliance initiatives and manage Quality Assurance, Quality Control and Sterility Assurance resources effectively, acting as Site Head of Quality. Partners with the Manufacturing Department to assure all standards, regulations and guidelines are followed in the manufacture of company products. Interacts with all areas and levels of the company in addition to regulatory agencies, vendors, consultants, suppliers, and other intended parties.

Currently leading and managing the implementation, deployment, and rollout (Globally) for end-to-end QA testing and Computer System Validation (CSV) of Veeva Vaults, Labware LIMS and Empower (CDS Tool).

Responsible for E2E testing, System Testing and UAT along with Validation of the system, Validated the software as per the FDA Regulation, Perform Risk assessment.

Worked on analytical method development and validation; stability and release testing; testing to support pharmaceutical development efforts.

Directly interacted with project team members, including presentation of data; critical review of data; preparation of technical reports; and evaluation of new instrumentation or analytical techniques.

Authored and certified Validation Plan, /Validation Protocols, (IQ, OQ, PQ), Requirements traceability matrix, and related documents.

Managed and monitored programs daily to track progress against the schedule, resolve risks/issues and manage program changes.

Overseen all phases of the implementation. Lead cross functional workstreams, establish project plans, track issues, manage deadlines, and drive on-time execution for strategic and tactical business initiatives

Ensured that delivery of each implementation has appropriate levels of quality, are timely, within budget, and in line with the Leadership Teams expectations.

Responsible for the tracking and reporting of all change with regards to delivery and associated budget implications as well as benefits and escalating issues and risks as appropriate.

Provided responsive, competent service and information to company management.

Responsible for managing All Equipment’s CSV related activities for Laboratories (QC Chemistry, Stability, Microbiology, Environmental Monitoring, Material Quality Management, QC Particulate and Method Validation) R&D/Technologies.

Provided technical assistance on new and existing products to other departments,

Also responsible for Audit Trails and Periodic Review of the Systems.

Maintained and enhanced data integrity compliance throughout laboratories.

Responsible for direct management and utilization of laboratory (analytical and microbiology), water treatment, syrup blending, sanitation, microbiological equipment, raw materials, and all quality processes.

Optimized resources while ensuring raw materials and finished product meet specifications and manufacturing standards and in accordance with FDA, GxP, HACCP, and all other governmental policies, procedures, and regulations.

Managed and maintained stability program under supervision.

Overseen daily Quality Assurance inspections to ensure all products are meeting compliance.

Managed quality assurance activities for all in-house GLP regulated studies and manage GCP Quality audit program for Investigational sites, CROs and third-party service providers.

Executed regulatory tasks for product development projects including health authority interactions (e.g. EMA, FDA), regulatory submissions (e.g. IND, CTA, MAA, BLA, NDA) and other regulatory requirements in line with corporate objectives, timelines and budgets.

Applied skills to assure management that nonclinical studies are conducted in accordance with applicable regulations.

Provided recommendations for corrective action and tracks corrective action commitments until closure.

Communicated critical compliance risks noted to senior management.

Scheduled, overseen and/or performed routine and non-routine GCP audits.

Managed CAPA follow up and effectiveness.

Tracked GCP commitments from internal audits, regulatory inspection findings, CAPAs and other regulatory commitments.

Served as the GCP subject matter expert for the audit staff and client areas.

Managed qualification and provides quality oversight of service providers contracted to perform any functions in support of GCP regulated studies.

Planned and conducted GCP and as applicable GPV regulated service providers to assess compliance with all pertinent regulations as well as company’s SOPs.

Collaborated with R & D, non-clinical and Clinical Operations staff to identify, evaluate and recommend solutions to issues identified in the performance of GCP audits.

Managed the internal audit program for GCP and responsible for scheduling, tracking and metrics.

Worked with other Quality functions to assure alignment and compliance with Iveric Bio’s Quality Management System, supported assessment of compliance and defined metrics to determine performance objectives.

Leads or support GCP inspection readiness, conduct and follow-up activities for clinical programs.

Assisted during FDA inspections.

Collaborated with Clinical Operations, Research and Development/Non-clinical and other relevant departments and Quality to determine acceptability of GCP Service Providers for potential engagement as well ongoing evaluation of overall compliance performance of Service Providers.

Provided technical assistance on new and existing products to other departments.

Provided guidance and leadership for staff and all departments to facilitate the Change Management and Document Control processes.

Reviewed weekly Change Control Board meetings to review all change controls for site.

Reported monthly on the status of the Change Management system as a member of the Quality Council.

Provided support for regulatory inspections and client audits related to pharmaceutical products.

Provided additional support as needed for the management of the Annual Products Review (APR) process and to support the completion of deviation investigations.

Managed staff and provided guidance for departmental representatives for the following processes:

odeviation investigations,

oproduct complaint investigations,

oCAPA, and Internal Auditing.

Acted as a host for regulatory inspections and ISO certification audits in support of both pharmaceutical and medical device products in compliance with 21 CFR 211, Health Canada, 21 CFR 820, and ISO 13485 requirements. Achieved the company’s first ISO Certification according to ISO 13485 standards and first successful Regulatory Inspection according 21 CFR 820.

AmerisourceBergen Corp. –American Health Packaging PA, Columbus, Ohio

Quality & Compliance Project Manager - AHP, Columbus, OH 09/2019 to 10/2020

Working on Business Technology Transformation a Supply Chain Management Program. Involved in the implementation of the Enterprise Resource Planning (ERP) solution on SAP S/4 HANA (On-premises edition) platform and Warehouse Management for Open System (WMOS) as part of the AHP Business Technology Transformation (BTT) program. Currently working on a site named American Health Packaging (AHP) located in Columbus Ohio.

Developed quality goals based on the business strategies that align with other functions in the organization as well as with the corporation.

Developed, implemented and maintained quality policies, processes, systems, and technology to ensure our products are safe, meet customer expectations, and comply with all applicable quality standards.

Led and managed QMS team to ensure adequate quality systems are implemented and maintained across the business to meet quality requirements.

QA responsibilities included but were not limited to GXP documentation review and approval for procedures related to QMS and process controls.

Interfaced with the Compliance management to implement quality system strategies and plans to facilitate continuous improvement of the QMS.

Also responsible for the quality of QMS documentation approved to support GxP activities for sponsor related projects.

Interfaced with other areas of the organization to provide sound QA decision-making in areas that impact the QMS.

Supported release readiness, Test script development, execution & data validation, metric tracking, reporting, AWS cloud migrations and assisting in the development, implementation, and maintenance of Quality Assurance best practices and FDA and international regulatory standards.

Provide quality oversight and input regarding discrepancy reporting such as non-conformances, and deviations related to sponsor projects and/or QMS; and provide final disposition of discrepancies that impact QMS.

Ensure adequate QMS infrastructure is maintained for sponsor projects; this includes meeting regulatory, international, and industry standards related to GxP activities.

Establish and report quality metrics related to the QMS and sponsor projects

Led and managed CSV Team for IQ, OQ & PQ followed by GAMP 4 & 5 Categories.

Established standards/metrics to monitor key product quality and quality system performance indicators, identify trends, and assure appropriate corrective & preventative actions. (i.e. Deviations, Customer Complaints, CAPA’s, etc.)

Also developed and implemented strategies, goals, and direction of the QA/QC functions to align with corporate strategies, meet the needs of the business, and applicable quality standards.

Investigated deviation and CAPA and mitigated, escalated and resolved them.

Responsible for development, implement, and training facility workers on a quality plan in order to be in compliance with quality regulations.

Developed plans that effectively support commercial needs in conjunction with Quality Systems Regulations.

Conducted regular Quality Management Reviews with senior managers to assess overall quality system health, identify trends, define corrective actions, and track completion/effectiveness.

Was accountable for effectiveness and continuously improving core Quality Systems.

Responsibilities included direct oversight of the following functions and accountabilities:

Quality control,

Investigations, and analysis.

Quality Assurance

Validation & Verification

Interacted with customers in addition to other departments to main product supply and help introduce new product.

Implemented and followed AHP’s quality procedures.

Educated visually and personally to employees at all levels on quality systems, results, issues, and focus areas to drive continuous improvement.

Lead Inspection Readiness (IR) activities for AR(American Regent) entities covering GxP, including Regulatory Affairs, and Medical Affairs.

Lead Pre-Approval Inspection (PAI) activities, identify Quality Risks and provide strategic solutions for continued improvement across the concerned activities.

Attended Requirement review meetings and responsible for Initial Risk Assessment (IRA) Plan.

Lead the validation and testing activities involved in Validation, QA and UAT team.

Prepared and performed GxP and Non-GxP related Functional Requirements’ Functional Risk Assessment of WMOS.

Monitored, Reviewed and Approved IQ, OQ and PQ Test Protocols for WMOS.

Managed several GxP Regulated system implementations and change controls.

Ensured execution of Corrective and Preventive action plans

Monitored performances of the resource (Consultants).

Wrote technical and management systems reports

Represented the company in FDA regulatory inspections and customer compliance audits

Author, review and approved Master Validation Plan, Validation Strategy, Risk Management Plan, etc.,

Currently Working on Training of the Products’ SOPs, Work Instructions, Process and Policies.

Developed plan for revision of current Processes/ SOPs

Developed roadmap for Skill set training

Revised or authored new SOPs

Tracked all the deliverables as per Validation Plan.

Prepared and submitted Validation Summary Reports along with Deviation form if any.

Johnson & Johnson Bridgewater, Somerset, NJ

Quality Compliance Project Manager 01/2019 to 09/2019

Worked on project called Depuy Spine Rainbow a Supply Chain Management Project. The application provides functionality to manage and record regulatory license information for multi-variant product, and provides controls to allow shipment of variants from ERP systems defined to receive can ship data from the RAD. The system was implemented as part of Project Rainbow and has been enhanced regularly since the initial implementation. The RAD receives product information from MDM to verify that product added to the system has been registered and exists within the organization.

Responsibilities include:

Ensured that all planned and unplanned quality & compliance issues were addressed.

Participated in creation of Project Plan, Test Plan, Test Strategy and Compliance report.

Identified and managed risks associated with a project and implemented strategies to reduce those risks; enforced project standards across the project teams and performed project reviews, including quality assurance and risk reviews.

Involved in Development and management of project timelines with adherence to agreed-upon milestones

Contributed in Budget tracking, bi-weekly estimate-to-actual reconciliation

Allocated resources and maintained online tasking system

Supervised Management of outside vendors and ensuring on-time deliverables

Attended Daily leadership of team status meetings and ongoing knowledge of all project statuses

Operated the team of 10 testers.

Lead the validation activities involved in a group of three.

Managed several GxP Regulated system implementations and change controls.

Defined the validation strategy, activities, and deliverables.

Managed and helped in creation of UAT Scripts, E2E Scripts for Various modules like; WMS (Warehouse Management System from Manhattan Assoc.), OTC (Order to cash), BOM (Bill of Materials), P2P (Procure to Pay), RTR (Record to Report) etc.,

Celgene Summit, NJ

Sr. Global QA Specialist 07/2018 – 12/2018

Collaborated closely with cross functional team members as a Sr. Global Quality System Specialist. Also reviewed Deviation, Change Request, and CAPA. Worked on Oracle EBS/MES and CAR-T project.

Established and overseen continuous improvement initiatives for worldwide commercial QA functions.

Managed team to perform CSV using HPALM.

Performed gap assessment against Quality SOP/WP/WI to identify the process gap.

Developed and maintained Deviation and CAPA for GxP and Non GxP Regulations.

Performed Root Cause Analysis.

Reviewed software UAT Scripts and defect reports on daily basis at the time of new release or enhancement of the system.

Led and performed audit for Oracle EBS Training. For GMP

Involved in Change Control Management Process.

Reviewed and approves SOPs and Work Practice Documents.

Well versed in working with Veeva Vault ETQ and eQRMS Tools.

Used Veeva as Electronic Document Management System (EDMS) including SOPs, Work Instructions, and Policies, Deviation, CAPA, etc.

Drove continuous improvement in Root Cause Investigation Process.

Also responsible for HPALM implementation.

Helped in training to obtain Traceability Matrix.

Johnson & Johnson New Brunswick, Bridgewater, Piscataway and Raritan, NJ Quality & Compliance Project Manager 09/2015 - 07/2018

Led/managed the team for SAP Data Migration /Conversion and data integrity testing of ABBOTT Vision Care Employees to Johnson & Johnson HR, Payroll and General Ledger System. Master Data Management (MDM) was used to define and manage the critical data of HR, Payroll and General Ledger provided with data integration which appears with increasing frequency as the volume and the need to share existing data explodes. Worked on Global Compliance wire training (LMS). Assisted the team to implement TrackWise (a Supply Chain Management Tool) globally. Also, reviewed and approved SOPs and WI and routed them to Document Management System. Worked on BtB SAP Applications as a Q&C Lead USA (LER), Canada & Japanese teams with help of offshore team of India. Was responsible for quality and compliance of test scripts for every test cycle, such as System Test, Integration Test, User Acceptance Test, Pre-and Post-Deployments Test. Also, responsible for change orders (CO) using Solution Manager.

Conducted gap analysis to analyze the status of the project.

Implemented the Quality plan in accordance with the quality objectives/goals and maintain the effectiveness of the quality system.

Managed Computer System Validation and Process Validation teams to compliance with GxP and Global Regulatory.

Promoted and ensure policies and procedures are in place so that Commercial activities meet applicable regulations and quality standards, minimizing the probability of quality/or compliance issues.

Also developed Company-wide quality system compliance with all applicable national and international standards and regulations.

Determined staffing and other resource requirements needed to achieve business goals and compliance requirements.

Directed complex global cross-functional process improvements.

Participated and managed department budgets and day to day activities of personnel.

Worked on SAP Solution Manager which is a product developed by the software company SAP SE. It is an integrated end-to-end platform intended to assist users in adopting new developments, managing the application lifecycle, and running SAP solutions.

Worked on groups of SAP applications which includes; SAP R/3, SAP Fico, SAP, MM, SAP CRM, SAP SRM, SAP BI, SAP MES, SAP BW, SAP ECC etc., modules.

Developed program QA plan (quality objectives, checkpoint) with program manager and delivery leads, based on Software Delivery Life Cycle (SDLC) Best Practices and J&J’s processes/policy.

Facilitated by leading internal and external audits and provides support during regulatory visits.

Demonstrated success interviewing user organizations to determine project, audit, and business requirements.

Operated Systems/Instrumentation and Control/Validation/Auditing/SDLC, Quality Assurance and Compliance.

FDA/EMA Internal Audit Preparation and Readiness for pharmaceutical manufacturing, NDAs, and Clinical Trials Operations.

Authored and/or reviewed of validation documents (URS, FRS, Qualification documents, Risk management, validation plan and validation summary report, incidents log, traceability matrix).

Supported the QA management of Veeva Vault applications (QualityDocs, QMS, etc.) through maintenance, Quality administration, training, and process improvement implementations.

Led the implementation and administration of QMS using Veeva Vault modules for Quality Events and Vendor Management

Established and implemented reporting tools within Veeva for analysis, trending, and reporting metrics.

Developed, Risk, and Quality Management. Monitor PCC for Analytics and implement Quality improvement projects, as appropriate.

Developed and implemented necessary communication strategy for the improvement and awareness of the quality issues. Monitor/report to upper management the status of Commercial QA.

Globally responsible for compliance to regulatory standards.

Responsible for Product Quality Complaint (PQC) and its escalation process.

Used TrackWise as a complaint management tool.

Managed external and internal audits to assess compliance with GCP requirements, investigational plans and

Company standards for clinical trial related activities.

Helped auditees to develop Corrective and Preventive Action Plans (CAPAs), addressing root causes. Knowledge of GXP Processes and GAMP 5 standards

Worked with Rational Tools developed for Enterprise Solutions like SAP, Oracle, etc.

Used HPALM for Q&C purpose in order to review requirements to test scripts, scripts execution, and end result, including defects.

Collaborated with the Director of Pharmacy Compliance and our Pharmacists in Charge, to assure current and future applicable local, state, and federal quality standards are met.

Acted as a change agent to drive continuous improvement and establish a customer-centric culture.

Responsible for migration requirements management within project scope, including the content and approval state of requirements.

Supported business process definition and Requirements update activities, as needed.

Reviewed and updated known Integration requirements during the Plan and Analysis phases, as needed through-out SDLC process.

Also, responsible to ensure all functional team members understand the meaning of requirements so they are properly revised, as needed developed and tested.

Smith Medical Keene, NH

QA / Validation Manager 03/2013 - 07/2015

Established and overseen continuous improvement initiatives for worldwide commercial QA functions.

Defined objectives in collaboration with executive management.

Developed quality goals based on the business strategies that align with other functions in the organization as well as with the corporation.

Developed plans that effectively support commercial needs in conjunction with Quality Systems Regulations.

Implemented the Quality plan in accordance with the quality objectives/goals and maintain the effectiveness of the quality system.

Promoted and ensure policies and procedures are in place so that Commercial activities meet applicable regulations and quality standards, minimizing the probability of quality/or compliance issues. Company-wide quality system compliance with all applicable national and international standards and regulations.

Determined staffing and other resource requirements needed to achieve business goals and compliance requirements.

Directed complex global cross-functional process improvements.

Developed roadmap for Skill set training

Managed System in compliance with CFR 21 Part 820 and ISO 13485:2016, communication with regulatory bodies, conducting audits and supporting compliant execution of quality-related processes.

Implemented and transferred of the QMS into the organization and ensuring that it is lived in everyday life.

Identified gaps or non-conformance in business - critical process and work with management to resolve in line with best business practice.

Reviewed and identified continuous improvements as required within the quality manual and policies and procedures necessary to the quality system.

Supervised and participated in delivery and execution of quality assurance artifacts that validated the requirements of the business are met.

Negotiated and communicated with cross-functional teams (stakeholders) in order to change control functions in global environment.

Strength included strong customer focus both internally and externally and building and maintaining relationship with key stakeholders.

Provided Quality review and guidance associated with investigations, change controls, protocols, reports, area releases, project planning and site procedures.

Actively involved in QA Document review, internal audit findings resolution, vendor audit compliance verification.

Led and managed an offshore team for the validation followed by FDA Regulations.

Heavy interaction with internal and external Key Stakeholders.

Managed and supervised the validation teams, validation consultants, and contractors for protocol development and execution, quality document review, compliance, and commissioning.

Improved performance of the Global team by increasing their efficiency and productivity significantly.

Managed multiple test environments to support various test levels, e.g., System Integration Test, Integration Test, and User Acceptance Test.

Coordinated and provided direction for QA assignments and activities across multiple applications and project initiatives.

Managed inspection readiness system and activities for the site, ensuring the sites are always in an inspection ready state

Conducted Good Clinical Practices (GCP) Risk Assessments.

Assisting in the development and implementation of the annual QA-GCP audit plan using a risk-based approach.

BioArrays Solutions/Immucor Inc. Warren, NJ

Sr. BA / QA Project Test Manager (AVP) 01/2011 - 03/2013

KeySoft Consulting Inc. Jersey City/Bridgewater, NJ

Sr. QA / BA Engagement Manager 10/2008 - 01/2011

Johnson & Johnson Raritan, NJ

Sr. QA Program / Engagement Manager 05/2007 - 10/2008

Organon USA Roseland, NJ

Global Integration System Test / UAT Manager 03/2005 - 12/2005

Pfizer Inc. Groton, CT /St. Louis, MO QA Manager 06/2004 - 03/2005

GMAC Insurance, St. Louis, MO: Lead Tester 08/03-05/04

Pfizer Inc., NYC: QA Lead 07/02-08/03

TBCT, Inc., NJ: QA Test Manager 12/98-06/02

Merrill Lynch Inc, NJ: QA Test Leader 04/98-11/98

PaineWebber, Inc, NJ: Lead QA Analyst 01/97-03/98

Education

Bachelor of Science in Chemistry & Biology (Dual Major), Bhagalpur University, INDIA

PMP Certified from PMI.

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