Pharmaceutical Quality Assurance and Regulatory Compliance Expert

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