Pharmaceutical Quality Assurance and Regulatory Compliance Expert

Technical Consultant #1946


Expertise

  • Pharmaceutical and biotechnical quality assurance.
  • Broad knowledge of GMP, GLP, ISO, ICH, FDA and International regulations.
  • Managing multiple projects and complex priorities.
  • Drug development, pharmaceutical manufacturing and aseptic processing principles and requirements.

Focused Areas

  • Product release
  • Production batch record
  • Change control
  • Commissioning, qualification and validation
  • Technical transfer; (method and process)
  • Investigation and investigation tools; (Brainstorming, 5 Whys, Fishbone Diagrams, etc.)
  • Quality risk assessment and risk analysis tools; (RRF, FMEA, PHA, etc.)
  • U.S. and International Board of Health (BOH) regulatory and Pre-Approval Inspections (PAI).
  • External supplier quality system and quality and technical agreement.
  • Consent decree remediation and CAPA Management for non-conformance.
  • SOP and job training aid.
  • External and internal audit.
  • Product customer complaint management.

Experience

Independent Consultant, Senior Quality System Consultant, 2012 - Present

  • Provide quality system consulting services to pharmaceutical API or drug companies in China on general quality systems improvement and implementation:
  • Quality project management.
  • Batch release and batch record review.
  • Deviation management.
  • OOS investigation.
  • Validation master plan.
  • Process evaluation and validation.
  • Computer system validation.
  • New facility commissioning and qualification; (QbD (ICH Q8, Q9, Q10).
  • Quality risk management and risk analysis tools.
  • Quality and technical agreement.
  • Technical transfer.
  • Regulatory compliance remediation project management.

Pfizer, (FKA Wyeth) Pearl River, NY, 2010 - 2011

Manager, PTxPharmScience Quality Assurance, Global Quality Operations

  • Managed the Investigation, release and validation sections of the quality unit group.
  • Managed the inspection readiness activities for FDA Pre-approval inspection and internal audit of the Legacy Wyeth Chemical and Pharmaceutical Development decommissioning activities.
  • Provided significant business continuity support to the Pfizer Pharmaceutical Science QA organization.
  • Planned, managed and brought to complete success the Legacy Wyeth CPD decommissioning project and activities.

Wyeth, Pearl River, NY, 2000 - 2010

Manager, Chemical & Pharmaceutical Development (CPD) Quality Unit

  • Managed and supported the various day-to-day activities of the quality unit line operation to assure the timely release of investigational materials and commercial products according to corporate quality standards, cGMP and regulatory requirements.
  • Created and managed the investigation system (MIR, LIR and product customer complaint).
  • Assured that CAPAs and/or remediation plans are completed in compliant and timely manner.
  • Established and managed the evaluation and approval of production batch records.
  • Revised and implemented the quality release system for production materials, intermediates, critical process aids, drug substances (API), bulk drug substances and final/finished drug products.
  • Developed and managed all aspects of change controls involving CPD Pearl River site.
  • As a subject matter expert, provided clear guidance and advise on facility and building projects.
  • Managed the implementation and execution of all validation activities, including review and approval of qualification / validation protocols, summary reports and validation master plan concerning analytical methods, cleaning and manufacturing processes, computer systems, utilities and facilities and equipment.
  • Responsible for external supplies quality management and for all aspects of quality and technical Agreements.
  • Acted as quality head and managed the contract manufacturing and contract testing activities of both investigational and commercial materials.
  • Made significant contributions to the consent decree remediation activities within the department, concerning product release, investigation, change control and validation.
  • Actively participated in internal audits, FDA and international regulatory and PAI inspections.
  • Served as steering committee member and led a significant cross functional team to design, commission, qualify and validate up to approval two $110 million biological and pharmaceutical manufacturing facilities.
  • Provided clinical and commercial manufacturing capabilities for biological and pharmaceuticals drug substances and drug products.
  • Successfully led and managed a significant cross functional quality team in a leadership role to fully establish a quality system for manufacturing and testing of commercial biological bulk drug substance and drug product.
  • Maximized the compliance readiness for regulatory inspections by performing pre-inspection assessments of internal and external GMP systems supporting the product testing and manufacturing activities.
  • Successfully led and managed several continuous improvement initiatives to significantly streamline the quality systems and processes concerning change control, release, production batch record review, investigation and quality and technical agreement.
  • Effectively administered personnel policies and practices, and provided appropriate project support, training, performance appraisal and career development coaching to direct reports.

Senior Research Scientist, Bioprocess Development, 1995 - 1999

  • Reporting to the department head, actively involved in manufacturing antibody-drug conjugates for clinical trials and commercial campaign.
  • Coordinated GMP related issues with production QA group.
  • Developed and revised production SOPs, batch records, technical reports and manufacture discrepancy investigation reports (MIR).
  • Managed production material release for GMP manufacture.
  • Provided supporting documentation for antibody-drug conjugate IND/NDA submissions.
  • Supervised and facilitated training on implementation of the GMP system within the department.
  • Prepared and executed qualification protocols for manufacturing equipment and utility systems.

American Cyanamid, Pearl River, NY, 1994 - 1995

Senior Research Scientist, Biotechnology Development and Analytical Research and Development

  • Developed and validated bio-analytical methods and assays to support antibody-drug conjugate projects.

Honors & Publications

Languages

  • Bilingual - English and Chinese

Academic and Professional Affiliations

  • American Chemical Society

Publications and Patents

  • Ten presentations
  • Papers
  • 25 patents

Education

  • Ph.D. Immunology, State University of New York School of Medicine, Buffalo, NY
  • B.S. Medicine, Beijing University School of Medicine, Beijing, China
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