DONALD BATES
Quality Professional with Global Experience
DONALD BATES
Quality Professional with Global Experience
About Me
Professional Summary
30+ years of global experience in leading GMP compliance, regulatory inspection management, risk mitigation, and strategic business alignment. Implemented global inspection readiness strategies across affiliates and CMOs. Experience with global regulatory agencies including FDA (USA), EMA (EU), MHRA (UK), HC (Canada), PMDA (Japan), ANVISA (Brazil), HSA (Singapore), and SFDA (Kingdom Saudi Arabia). Ensure 500+ worldwide GXP vendors adhere to regulations by managing 175+ annual audits driving continuous compliance. Personally recognized by Amgen CEO for promoting a sense of community and mentoring through volunteering in an employee support group.
Leadership Experience by Area
Quality
- Led multiple Quality organizations up to 30 personnel for Product Disposition, Quality Systems, Training, Vendor Management, Mock Recalls, and Internal Audits
- Led GXP inspection readiness efforts, serving as host or SME for PAI (US/EU/Canada), WDA (Ireland), GDP (Ireland/Germany/Netherlands), BIMO (US/Canada), and PADE (US/Germany) audits. Supported inspections by Singapore, Japan, China, Brazil, and Kingdom of Saudi Arabia.
- Spearheaded a corporate-wide regulatory intelligence and inspection readiness program to proactively address regulatory trends.
- Developed and implemented a risk-based auditing methodology to improve compliance and efficiency while overseeing 500+ GXP vendors worldwide and 175+ vendor audits annually
- Provided strategic leadership to establish a consistent GMP framework. Developed and implemented the Quality Master Plan, GXP Quality policies, Quality Agreements, Material Review Boards, and Global Quality Manuals
- Responsible for commercial launch of products distributed in Canada, United States, EU, LATAM, and JAPAC regions.
Manufacturing and Supply Chain Management
- 10+ years' experience with multiple startups including several aseptic / transdermal / solid dosage facilities
- Manage worldwide CMO/CDMO Contract Drug Manufacturing Organizations including selection and contract negotiation, Equipment Purchase, Tech Transfer, Scale-up, Engineering Runs, Clinical Production, Registration Batches, and Commerical Launch.
Regulatory
- Generation of Chemistry, Manufacturing and Controls (CMC) portions for the following regulatory filings: INDs, NDAs, aNDAs, BLAs, IMPDs, NDSs, MAAs, and PASs.
- Experienced in identifying and resolving regulatory compliance issues.
- Issuance of FARs and BPDRs
- GXP inspection readiness efforts, serving as host or SME for PAI (US/EU/Canada), WDA (Ireland), GDP (Ireland/Germany/Netherlands), BIMO (US/Canada), and PADE (US/Germany) audits. Supported inspections by Singapore, Japan, China, Brazil, and Kingdom of Saudi Arabia.
Qualification/Validation
- Led Factory / Site Acceptance Testing, Commissioning, Risk Assessment (FMEA / FMECA), Stage Gate Review, Design Qualification, Design Verification, Equipment Qualification (IQ/OQ/PQ), Computer Validation, Cleaning Validation, and Process Validation
Professional Experience
Amgen Inc./Horizon Therapeutics [Sr. Director, Compliance / Corporate Quality, October 2016- Present
Amgen Inc./Horizon Therapeutics [Sr. Director, Compliance / Corporate Quality, October 2016- Present
Amgen Inc./Horizon Therapeutics [Sr. Director, Compliance / Corporate Quality, October 2016- Present
- Lead GXP inspection readiness efforts, serving as host or SME for PAI (US/EU/Canada), WDA (Ireland), GDP (Ireland/Germany/Netherlands), BIMO (US/Canada), and PADE (US/Germany) audits. Spearheaded a corporate-wide inspection readiness program to proactively address regulatory trends. Supported inspections by Singapore, Japan, China, Brazil, and Kingdom of Saudi Arabia.
- Developed and implemented a risk-based auditing methodology to improve compliance and efficiency while overseeing 500+ GXP vendors worldwide and 175+ vendor audits annually
- Implement corporate GXP Quality policies, Quality Agreements, and Global Quality Manuals, enhancing inspection readiness and regulatory compliance across global sites.
- Manage multi-million-dollar functional budgets, ensuring cost-effective resource allocation and departmental goal achievement.
- Provide strategic leadership to cross-functional teams, mentor emerging leaders, and drive cultural transformation to reinforce a quality centric mindset and compliance driven behaviors.
Raptor Pharmaceuticals [Sr. Director Quality Assurance, 2015 - 2016]
Amgen Inc./Horizon Therapeutics [Sr. Director, Compliance / Corporate Quality, October 2016- Present
Amgen Inc./Horizon Therapeutics [Sr. Director, Compliance / Corporate Quality, October 2016- Present
- Led the Global Quality organization on Quality compliance and regulatory requirements across multiple functions. Provided strategic leadership to establish a consistent GMP framework. Developed and implemented the Quality Master Plan, delivered technical guidance to reduce batch rejection.
- Responsible for commercial products distributed in Canada, United States, EU, LATAM, and JAPAC regions.
- Provided regulatory leadership for IND/IMPD, NDA/NDS, MAA, and other submissions, to support global market expansion as well as hosted PAI (Canada) and GDP (Netherlands) inspections
- Oversee Product Disposition, Vendor Oversight/qualification, Deviations, Change Controls, CAPAs, Specifications, SOPs, Training, Quality Agreements, Material Review Board, and Recalls.
- Implemented global GXP strategies ensuring corporate quality goals were aligned with international regulatory requirements and evolving compliance landscapes.
- Established and managed departmental budget, goals, and performance metrics, staff career development and external consultants.
Professional Consulting Experience
Donald Bates Corporation (DBC) [Principal June 1996 to 2016]
Principal of a full-service GMP readiness and compliance consulting firm for over 20 years. Specialized in inspection readiness, risk management, vendor oversight, quality systems, and regulatory submissions for the following:
- Abgenix Inc.
- Alza Pharmaceuticals
- Automatic Liquid Packaging
- Axm Pharmaceuticals
- Bayer AG
- Cardinal Health
- Cell Genesys Inc.
- Chiron Corporation
- Collagen
- Dynavax Inc.
- Elan Pharma
- Genentech
- Grifols
- Intarcia Therapeutics
- Isis Pharmaceuticals
- Johnson and Johnson
- MAP Pharmaceuticals
- Medicines360
- Merck
- Novartis AG
- Novo Nordisk Delivery Technology
- Onyx Pharmaceuticals
- Ortho-McNeil Pharmaceuticals
- Procter and Gamble
- Raptor Pharmaceuticals
- Schering Plough
- Threshold Pharmaceuticals
- Warner Lambert
- Wyeth
The following summarizes key consulting services delivered.
Professional Consulting Experience
Raptor Pharmaceuticals, Novato, CA [Quality Assurance/CMC, 2015]
- Head of Quality organization responsible for Batch Release, Vendor Management, Deviations, Change Controls, CAPAs, Specifications, Policies, Quality Technical Agreements, Material Review Board, and Recalls/FARs
- Managed and mentored staff ensuring timely completion of Annual Product Quality Review, NDS submission, FARs, and IMPD updates driving continuous quality improvements and adherence to global health authority requirements.
Intarcia Therapeutics, Hayward, CA [Quality Assurance, 2015-2016]
- Served as QA SME approver of over 100 protocols and reports for the following: Equipment Qualification (IQ, OQ, PQ), Cleaning Validation, Gamma Sterilization, and Process Validation.
- Led QA approval process for Batch Records, SOPs, contamination risk control strategy and Process/Product Risk Assessments strengthening risk management and regulatory adherence.
Dynavax, Berkeley, CA [Quality Assurance, 2012-2014]
Dynavax, Berkeley, CA [Quality Assurance, 2012-2014]
- Directed global Drug Substance (DS/IMPD) and Drug Product release activities, ensuring adherence to regulatory standards for worldwide manufacturing operations.
- Oversaw Contract Manufacturing Organizations (CMOs) and Distributors (3PL, 3rd Party Logistic Providers) ensuring readiness for commercial product launch.
- Led QA oversight on four early phase clinical/toxicology/GLP studies responsible for approving SOPs, Method Validation Reports, Specifications, Validation Protocols and Reports, and Drug Product QP release.
Medicines360, San Francisco, CA [CMC, 2011-2012]
Onyx Pharmaceuticals, South San Francisco, CA [PAI Readiness, 2011-2012]
Dynavax, Berkeley, CA [Quality Assurance, 2012-2014]
- Managed CMO operations for a phase II/phase III combination hormone releasing device/drug combo product ensuring GMP compliance and regulatory alignment.
- Developed and Implemented Manufacturing Instructions, Technical Reports, Project Plans, Validation, Specifications, and SOPs optimizing production and quality processes.
MAP Pharmaceuticals, Mountain View, CA [Quality Assurance, 2011-2012]
Onyx Pharmaceuticals, South San Francisco, CA [PAI Readiness, 2011-2012]
Onyx Pharmaceuticals, South San Francisco, CA [PAI Readiness, 2011-2012]
- Oversaw Vendor Qualification process for over 100 different vendors by conducting risk assessments, Vendor Survey, Audits, and establishing criticality based on vendor requirements.
- Directed closure of Deviations, CAPAs, Internal and External Audit Observations driving compliance and operational efficiencies.
Onyx Pharmaceuticals, South San Francisco, CA [PAI Readiness, 2011-2012]
Onyx Pharmaceuticals, South San Francisco, CA [PAI Readiness, 2011-2012]
Onyx Pharmaceuticals, South San Francisco, CA [PAI Readiness, 2011-2012]
- Led Mock PAI GMP readiness program to ensure NDA related compliance timelines were met to facilitate regulatory approval.
Threshold Pharmaceuticals Inc., Redwood City, CA [Acting Head of Manufacturing, 2005-2010]
Threshold Pharmaceuticals Inc., Redwood City, CA [Acting Head of Manufacturing, 2005-2010]
Threshold Pharmaceuticals Inc., Redwood City, CA [Acting Head of Manufacturing, 2005-2010]
- Directed and managed contract manufacturing operations across multiple domestic and international CMOs, overseeing the production of drug substance (API) and drug products (aseptic and oral dosage).
- Led global inventory control efforts for multiple clinical-stage products, ensuring seamless coordination with importers and exporters for multinational shipments across Russia, Eastern Europe, India, and Israel.
- Oversaw technology transfer initiatives, optimizing process scale-up and manufacturing efficiency to support product commercialization.
- Spearheaded the development and submission of Investigational New Drug Applications (INDs) and multiple Investigational Medicinal Product Dossiers (IMPDs), ensuring regulatory compliance and alignment with global health authority requirements.
- Managed the generation, review, and approval of key quality and compliance documents, including Deviations, Change Controls, CAPAs, SOPs and Protocols, fostering a robust GMP-compliant manufacturing environment.
Novartis / Chiron, Emeryville, CA [QA / Manufacturing, 2006-2008 & 2010]
Threshold Pharmaceuticals Inc., Redwood City, CA [Acting Head of Manufacturing, 2005-2010]
Threshold Pharmaceuticals Inc., Redwood City, CA [Acting Head of Manufacturing, 2005-2010]
- Conducted comprehensive Discrepancy investigations through review of batch records, Environmental Monitoring trends, process improvement through document revision and manufacturing process changes.
- Led Corrective Action implementation programs, optimizing training, facility modifications, and CAPA strategies to enhance GMP compliance.
Bayer Healthcare, Emeryville, CA [QA, 2009-2010]
Threshold Pharmaceuticals Inc., Redwood City, CA [Acting Head of Manufacturing, 2005-2010]
Bayer Healthcare, Emeryville, CA [QA, 2009-2010]
- Led closure of FDA observations and internal audit responses through revision of SOPs, training programs, and development of internal policies.
- Created process to ensure equipment calibration, user ranges, and tolerances align.
Professional Consulting Experience
Novo Nordisk Delivery Technology, Hayward, CA [Acting Head of QA, 2007-2008]
- Led Review and Approval of over, 100 SOPs, 150 qualification protocols/reports, 300 User and Function Specifications, Basis of Design, and various project plans.
- Collaborated with cross functional teams from Brazil, North Carolina, and Denmark to establish enterprise-wide Quality Systems for electronic document tracking, review, and approval.
- Conducted vendor audits to ensure compliance with Novo Nordisk and global regulatory expectations.
Genentech, South San Francisco, CA [QA/Validation/Regulatory, 2006-2009]
- Developed multiple Prior Approval Supplements (PAS) for new multi-product aseptic facilities.
- Reviewed over 75 IQ/OQ/PQ/CQ protocols and summary reports for various manufacturing equipment.
- Created risk mitigation strategies (FMEA, SIA, CCA, PHA, RCS).
- Led Qualification efforts for Building Automation Systems (BAS), temperature monitoring systems, cold rooms, VHP isolators, and microbiology lab equipment.
Cell Genesys Inc., Hayward, CA [Manufacturing/QA/Regulatory, 2006-2007]
Cell Genesys Inc., Hayward, CA [Manufacturing/QA/Regulatory, 2006-2007]
- Led discrepancy investigations by evaluating validation, production records, training, and change control data to ensure compliance.
- Managed annual IND updates, conducting batch record reviews, change control assessments, and quality control evaluations.
Axm Pharma, Shenyang, China [QA/Manufacturing, 2003-2005]
Cell Genesys Inc., Hayward, CA [Manufacturing/QA/Regulatory, 2006-2007]
- Ensured two new manufacturing facilities were designed and built to US GMP specifications for the manufacturing of 42 different drugs in Shenyang, China
- Oversaw the preparation of over 1,200 documents including SOPs, commissioning documents (FAT/SAT), validation protocols (IQ/OQ/PQ/PV), batch records, and specifications.
- Directed cross-functional teams of US Engineers, Validation Specialists, QA/QC Managers, Laboratory Technicians, and Production Supervisors in their assigned tasks to ensure that the manufacturing equipment, facilities, utilities, and laboratories to ensure cGMP criteria are met.
- Acted as the primary liaison with the US FDA to coordinate Pre-Operational Reviews.
Elan Pharma, Athlone, Ireland [Validation Auditor/Director, 2001-2002]
- Provided Quality oversight for over 200 validation protocols and User Requirement Specification documents at a new $250 million startup aseptic and oral dosage facility in Athlone, Ireland.
Alza Pharmaceuticals (a J&J Company), CA [Quality / Validation, 1996-2004]
- Led qualification activities for a new aseptic manufacturing facility for DUROS implants.
- Established a change control database and process to track the status of over 1,000 pieces of equipment and 4,000 documents.
- Served as Subject Matter Expert on Equipment and Facility Validation during FDA and internal audits.
- Managed validation budget and deliverables of over 24 contractors from 6 different companies.
- Wrote and executed over 200 IOQs for process equipment, facilities and utilities. computer, process, and cleaning validation protocols. Summarized data collected during IOQ and PQ processes to prepare Validation Master Plan summary report.
Ortho-McNeil Pharmaceuticals, Redwood City, CA [Project Management/Validation, 2001-2002]
Ortho-McNeil Pharmaceuticals, Redwood City, CA [Project Management/Validation, 2001-2002]
Ortho-McNeil Pharmaceuticals, Redwood City, CA [Project Management/Validation, 2001-2002]
- Led validation efforts for isolators, ovens, Water systems, HVAC, and Facility Qualifications.
Education and Publications
Drexel University, Philadelphia, PA, Bachelor of Science in Chemistry
- Collecting and Using the Chemical Elements, by S. Solomon and D. J. Bates, Journal Of Chemical Education (1991) 68 p.991-995
- Quantitative Determination of Phosphorous in Plant Food Using Household Chemicals, by S. Solomon, D. J. Bates, and A. Lee, Journal Of Chemical Education (1993) 70, p.410-412