- 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.
- 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.
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
- Bilingual - English and Chinese
Academic and Professional Affiliations
- American Chemical Society
Publications and Patents
- Ten presentations
- 25 patents
- Ph.D. Immunology, State University of New York School of Medicine, Buffalo, NY
- B.S. Medicine, Beijing University School of Medicine, Beijing, China