Quality Assurance Director level
Resume:
Julie-Susan Harrison
South Easton, MA. 02375
*****-*****@*******.***
Pharmaceutical, Biopharmaceutical and Medical Device professional leader in Quality Assurance. Experienced in all aspects of Quality Assurance, Regulatory Affairs, Commissioning, Validation, Lot Release, Manufacturing and Continuous Improvement.
Over twenty years of experience in the biotech and pharmaceutical industries in Quality Assurance, Regulatory Affairs, Validation, and Manufacturing capacities. Strong FDA / EMEA experience. Subject Matter Expert in injectable formulation PAI Preparation, Quality and Compliance, Material Qualification, Process Validation and Multi Product Facilities.
Pre-IND through NDA/BLA (including eCTD) and post-approval in-depth experience. FDA, CDC, NIH, DoD, and EMEA interaction. Clinical and CMC Regulatory responsibilities, experienced in Biologics (vaccines and recombinants), Drug and Combination Product Regulatory knowledge.
Extensive experience and proven success in Consent Decree settings, including Interim Controls, Batch Record Remediation, Investigations and CAPA, Work Plan execution and Verification activities.
Well versed in ICH guidelines with international experience. Proven ability to design and implement Quality concepts and controls into the GMP manufacturing as well as the GCP and GLP environments. Extensive experience in developing, managing and directing cGMP and GLP Compliance and Quality programs. In addition to extensive hands-on experience, has a proven record of management. Skilled in the use of MS Word, Excel, Access, Power Point, Visio, Project, Lotus Notes, Outlook.
Strong management capabilities and extensive experience in multi-disciplinary team management in support of batch record review of 500 plus records per month. Solidly committed to providing strong support to achieve success.
Successful management of 30 -plus consultants as Site Lead for Investigations numbering over 250 per month, driving to 30-day closure and reduction of backlog.
Experience includes development and maintenance of internal cGMP policies and procedures, and assuring comprehensive compliance through strong and effective oral and written skills. In-depth experience including but not limited to the following:
Expert in the use of TrackWise
Six Sigma (Green Belt Certified)
Material Qualification, Extractable and Leachable Study Generation.
MES expert (Manufacturing Electronic Batch Record Systems, i.e. Werum).
Batch Record Review
Master Batch Record Remediation
CAPA, Investigation and Deviation processes
Packaging and Labeling
Clean room/Aseptic fill/finish processes.
Cell culture/bioreactor/roller bottle operations.
API/Bulk protein purification and drug formulation.
Lyophilization.
Environmental Qualification.
Chromatography capture, clarification, purification.
Microbiological and Environmental Controls.
Clean room design and operation.
Validation of critical processes, equipment and systems.
Viral reduction and inactivation processes.
Microbiological testing.
Quality Experience
Lot release activities
Internal and External Auditing
Managing and hosting regulatory and internal inspections.
Field Alert Reports (FAR), Recalls, Complaints
Successful and effective remediation plan implementation for audit and inspection findings.
Development and maintenance of all cGMP and GLP policies and procedures, and assuring comprehensive compliance.
In depth knowledge of 21CFR, USP, EU, ISO.
CAP/CLIA compliance.
Raw materials release, in-process inspection, man-in-plant.
Deviations, Investigations, CAPA and Effectiveness Review
Continuous Improvement
Manufacturing Process Experience
Cell Culture, Media Preparation, Human Collagen Protein Purification, Viral (Vaccinia, JE, WN injectable vaccines), Mammalian (VERO) (BHK).
Factor VIII injectable (hemophilia treatment).
Vaccine Experience
Smallpox injectable, Modified Vaccine Ankara Smallpox Injectable, Warm Base Vaccinia, JE, WN, Influenza/Flu Injectable, HSV and C. difficile team member.
Comprehensive Fill and Finish Experience
Vials, ampoules, syringe filling
Lyophylization
Visual inspection
Packaging and labelling
Management Experience
Over twenty-two years management experience in Manufacturing and Production.
FDA Experience
Supported the generation and execution of the Validation Program for ACAM2000 / Warm Base with direct FDA CBER input over a course of two formal Site Visits.
Medical Device Experience
Support of engineering, manufacturing and regulatory functions.
Contributed to developing and implementing quality control and inspection procedures for receipt and control of incoming materials, in-process materials and final product acceptance.
Co-authored/reviewed/approved quality control standards and tests; test equipment specifications and procedures; reviewed/approved test instrument calibration procedures and contributed to sustaining maintenance schedules.
Responsible for maintaining specific quality metrics, analysis of these metrics, and reporting trends to management.
Reviewed and sat on board for nonconforming materials.
Participated in design development, testing and design control activities to ensure regulatory requirements were met.
Contributed to maintaining sterilization validation and material biocompatibility activities (material qualification, etc.).
Co-authored technical documentation, product requirements, design requirements, software requirements specifications, functional specifications.
ASQ Certified Quality Auditor (CQA) Certified
Six Sigma - Green Belt Certified
Method One – Yellow Belt Certified
Professional experience
Site Lead for Investigations, CAPA
Client – Pfizer, McPherson, Kansas
Consultant, April 2018 to current
The ProClinical Group, London, England
Lead for four work stream investigation teams for fill and finish facility. Perform investigations, manage and lead 32 consultants to successfully implement the DMAIC approach to root cause, and 30-day completion cycle. Report to and interact directly with Site Leadership Team; provide guidance for continuous improvement and remediation, and maintain team metrics.
Lead for Batch Record Review, Inspection Readiness and Internal Audits
Client - Getinge, New Jersey three sites – Wayne, Fairfield and Mahwah
Consultant, December 2016 to April 2018
The Quantic Group, Ltd., Livingston, NJ
Leader for Batch Record Review, Internal Audits and Inspection Readiness. Manage a large team of reviewers of batch records against the client’s site approved standard operating procedures, standards and regulatory requirements. Support lot release activities and review Certificates of Analysis. Provide guidance for deviation generation and CAPA. Major contributor in meetings with the client’s Site Leadership (Managers to Vice Presidents) to address product quality-related issues, and provide guidance for continued compliance and improvement. Provide monthly reports summarizing activities and findings. Lead auditor at three Getinge, New Jersey sites.
Interim Control Lead for Batch Record Review and Change Control groups
Client – Sanofi-Genzyme Massachusetts-two sites Framingham and Allston
Consultant, December 2010 to November 2016
The Quantic Group, Livingston, NJ
Leader of U.S. site FDA Consent Decree for two groups at two different sites, the Batch Record Review Interim Control Group and Change Control Interim Control Group. Manage a large team of reviewers of batch records against the client’s site approved standard operating procedures, standards and regulatory requirements. Support lot release activities, review Certificates of Analysis, and review and manage the review of Change Controls. Provide guidance for deviation generation and CAPA, support effectiveness review. Review of submitted responses to batch record observations. Major contributor in meetings with the client’s Site Quality Council (Managers to Vice Presidents) to address product quality-related issues, and provide guidance for continued compliance and improvement. Maintain Quantic batch record database (MS Access). Provide monthly reports summarizing activities and findings of each Interim Control group. Major contributor for Batch Record Remediation.
Director of Quality Assurance, March 2010 - December 2010
Cambridge Biomedical, Inc.
Responsibilities included leading the company in establishing a fully compliant GLP and CAP/CLIA Quality Assurance Unit. Overall management of all quality activities.
Manage compliance for the CLIA/CAP laboratory.
Maintain compliance in GLP/GMP/CAP/ CLIA regulations.
Maintain Master Schedule Logbook of all studies conducted at the testing facility.
Foster strong relationships with CMO partners.
Developed and implemented QA policies and programs including CAPA, Deviation Reporting, Internal/External Audits, and Validation.
Reviewing and approval of GLP study protocols.
Auditing all GLP studies to assure compliance and the integrity of the study.
Assuring that deviation from protocols / SOPs /Policies, and the impact on the study, are documented, resolved through appropriate CAPA, and properly authorized.
Assuring implementation and documentation of the appropriate corrective and preventive action.
Authoring Quality Assurance standard operating procedures (SOPs) for the conducting audits, corrective action, follow-up and closure, indexing, retention and archiving.
Evaluation of subcontractors to assure compliance to the applicable regulations.
Reviewing and providing complete analytical method documentation including notebooks, development reports and method validation protocols and reports.
Hire, train and develop QA staff.
Manage, budget and track activities in Quality, including commissioning and validation.
Evaluate suppliers of products and services.
Associate Director of Quality Assurance, March 2008 to February 2010
Biomeasure, Inc.
Responsibilities include leading the company in establishing a Phase 3 biotech manufacturing plant for API.
Lead and manage Deviation, Investigation, CAPA and Change Control activities.
Manage, budget and track activities in Quality, including commissioning and validation.
Evaluate suppliers of products and services for capability and regulatory compliance.
Establish and implement all quality systems for the operation.
Hire and develop staff for the QA group.
Develop QA policies and procedures to ensure compliance with protocols, FDA and EMEA regulations.
Established a system of SOPs for all FDA/EMEA-regulated activities and took the lead in changing corporate culture from a research to a regulated environment.
Assisted all departments in defining and formalizing processes.
Trained all employees in GMP and self-inspection.
Ensure compliance and track regulatory requirements for manufacturing, including change control and deviations through quality audits, batch record review and implementation of internal systems.
Established Quality Agreements with contractors and corporate partner.
Reviewed and approved protocols and reports for development/validation of processes, analytical methods, stability and other support systems.
Lot release and disposition.
Associate Director of Validation, March 2007 to March 2008
Acambis Inc./Sanofi Pasteur
Responsible for approach determination, prioritization and management of all validation activities at Acambis Inc. Canton. Managed a staff of four full time and four contract employees.
Authored CMC section of JE eCTD submission.
Authored/Reviewed CMC regulatory submissions.
Original team member of ACAM2000 BLA generation and submission, resulting in Licensure in 2007.
Liaison with FDA, TGA and EMEA Regulatory bodies.
Subject Matter Expert representing Validation at all Project Meetings for multiple products (Warm Base Vaccinia, JE, WN, Influenza/Flu, HSV and C. Difficile).
Contributor to Deviation, Investigation, CAPA and Change Control activities.
Maintain spending within budget for Cambridge and Canton, MA.
Generate, develop and manage budget for Validation.
Generate multiple Requests for Proposals for future work.
Validation Manager, August 2005 to March 2007
Acambis Inc.
Assist in Generation and development of 2005, 2006 and 2007 budget for Validation for multiple sites.
Managed a staff of four full time and four contract employees which facilitated completion of aggressive plan for first product. Assignments included quality program development, computerized systems, cleaning validation and quality documentation development.
Extensive interface with FDA CBER, CDC and HHS over the course of the ACAM2000 Fast Track project.
Authored CMC section of ACAM2000 eCTD submission and subsequent questions from CBER.
Created and implemented multi-product validation program for ACAM2000, JE, Clostridium Difficile and WN vaccines.
Developed and executed
oProcess / Shipping / Cleaning Validation efforts for two vaccine products
oMaterial Qualification efforts for two vaccine products
Developed and implemented
oQuality and Validation programs through an aggressive phase of facility start-up which included: change control, CAPA system, audit and inspection, computerized system risk assessment, product changeover and comprehensive material qualification, extractables and leachables studies.
Subject Matter Expert for biotech, process validation, shipping validation, cleaning validation and automation validation.
Developed and implemented QA policies and programs in addition to developing PQ, MQ, PV, SV and CV efforts.
Developed and managed engineering study and qualification protocols.
Characterized operational ranges in preparation for process validation effort.
Conducted multiple process improvement audits, gap analysis audits, generation of subsequent CAPA, development of site VMP.
Conducted QA audits, review validation documents and generated multiple VMPs.
Validation Project Manager, July 2003 to July 2005
Acambis Inc.
Contributed to the management of Quality and Validation oversight of CMOs (CBL, HS and Baxter) and a European cell culture CMO.
Management of technical consultants, business development and project management.
Developed and implemented programs and executed PQ, MQ, PV, SV and CV efforts.
Validation Engineer, July 2001 to August 2003
IPS, Inc.
Commissioning and Validation.
Management of technical consultants, project management.
Developed and executed PQ, MQ, PV, SV and CV efforts.
Manufacturing Supervisor, June 1997 to June 2001
Collagenesis, Inc.
Biomaterials / medical device company focused on developing, processing and marketing advanced tissue-based solutions.
Education
BS, Health Sciences
oQuinnipiac University
AS, Biotechnology
oNorth Shore Community College
Course work, Biology
oSalem State College
AS, Small Business Management and Culinary Arts
oNorth Shore Community College
Memberships
ISPE, PDA, ASQ
Seminars
Lyophilization, Extractables and Leachables, Process Analytical Technology, GAMP 4/5, Technology Transfer, Isolation Technology, Design of Experiments for Process Validation, Disposables Technology.
Publications
Pharmaceutical Engineering; "Outsourcing"
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