Stephen R. Lubeck
Pleasant Hill
Summary
Quality Assurance and Compliance Leader with extensive experience in end-to-end Quality Assurance operations and regulatory compliance. Led the establishment of a global Vendor Management Program and directed complex QA projects, ensuring timely delivery and alignment with organizational standards. Strong cross-functional leadership and commitment to continuous improvement drive operational excellence.
Overview
1
1
Certification
32
32
years of professional experience
Work History
Executive Director, Compliance QA
Exelixis
Alameda
11.2021 - 07.2026
- Established a risk-based global Vendor Management Program covering onboarding through retirement, strengthening oversight of CDMOs, CROs, 3PLs, storage facilities, warehouses, and external labs.
- Managed team of five associates and two contractors, ensuring effective execution of Compliance QA operations.
- Directed the development, negotiation, and maintenance of Quality Agreements and Quality Questionnaires for all approved external partners and vendors.
- Led enterprise Inspection Readiness for Clinical and Commercial operations; served as primary host for customer audits and Health Authority inspections (MHRA, Swissmedic, FIMEA, and supported FDA BIMO).
- Conducted global GxP vendor and partner audits, implementing remediation and continuous improvement initiatives.
- Served as a standing member of the Quality Risk Management team, identifying and mitigating compliance and program risks.
- Served as interim Quality CSV lead, overseeing validation strategy and execution for cloud-based data management applications.
- Built and led Compliance QA organization, overseeing Supplier Quality, External Audits, Internal Audits, and Inspection Readiness programs with a team of four.
Executive Director, Clinical/PV Quality
Exelixis
10.2025 - 06.2026
- Directed GCP and GVP Quality Systems, embedding Quality principles across Clinical Development, Global Patient Safety, and Regulatory functions.
- Led Clinical QA strategy, policies, and procedures to ensure GCP compliance and robust oversight of GCP/GVP vendors.
- Managed team of three associates and two contractors, overseeing Clinical Quality operations and driving continuous improvement initiatives.
- Enhanced BIMO inspection readiness through collaboration with Clinical Operations, Regulatory Affairs, and Safety teams.
- Served as Quality representative on Clinical Study Teams, ensuring data integrity, risk management, and proactive issue escalation.
- Reviewed and approved Clinical Site audit reports, ensuring compliance and quality standards.
- Conducted ICH E6(R3) gap assessments and aligned QMS procedures with updated regulatory expectations.
Head of Quality Operations
Lonza
Hayward
04.2020 - 11.2021
- Led twenty-person QA organization supporting clinical mammalian cell-culture manufacturing, driving Batch Record Review, on-the-floor QA, Raw Material Release, Product release, and Document Control.
- Oversaw deviation/CAPA, product release, and change control lifecycle management to ensure compliance and quality standards.
- Managed Quality Agreements, Customer Quality interactions, and Supplier Quality programs to enhance stakeholder collaboration and satisfaction.
- Drove operational improvements and Commercial Readiness initiatives to support scale-up and tech transfer.
- Sponsored and championed continuous improvement initiatives—such as Lean and Six Sigma green belt projects—that reduced deviations, improved process capability, and strengthened operational efficiency.
- Conducted customer audits to assess compliance and improve quality standards. and Health Authority inspections.
Director, Quality Assurance Operations
Grifols
Emeryville
07.2017 - 01.2020
- Led global team of five regional QA associates and six-person complaint handling team for non-Grifols-manufactured products, enhancing operational effectiveness.
- Directed global qualification, approval, and auditing of third-party distributors, suppliers, and warehouses.
- Ensured compliance of distributors and warehouses with Grifols Quality System, facilitating global business expansion.
- Managed Quality Agreements while overseeing budget forecasting, planning, and performance tracking to align with strategic objectives.
- Conducted self-inspections, vendor audits, and served as a key escort during Health Authority inspections and ISO certification audits.
- Provided global Quality Oversight for Procleix Blood Testing product lines (reagents and instruments).
Director, Quality Assurance
Grifols
Emeryville
06.2014 - 07.2017
- Led a twenty-five-person QA organization spanning Fermentation, Purification/Fill/Finish, Validation, QA on the Floor, Development QA, Complaint management and Distribution QA.
- Managed performance of DR, CAPA, Complaint, and Change Control, enhancing on-time closure and compliance metrics.
- Guided post-merger QA integration, aligning upstream and downstream manufacturing units with Grifols Quality model to ensure seamless transition.
- Represented Quality on Partner Operating Committee, overseeing product changes, deviations, and complaint support to maintain regulatory compliance.
- Conducted self-inspections, vendor audits, and supported Health Authority inspections and ISO Certification audits.
Director, Alliance Products Quality Assurance
Novartis Diagnostics
02.2011 - 06.2014
Associate Director, Tech Ops Validation (Site Head of Validation)
Novartis Diagnostics
07.2005 - 02.2011
Validation Manager, Blood Testing Division
Chiron Corporation
08.2000 - 07.2005
Senior Validation Specialist, Blood Testing Division
Chiron Corporation
03.1999 - 08.2000
Validation Specialist, Blood Testing Division
Chiron Corporation
05.1997 - 03.1999
Purification Operator, Biopharma Division
Chiron Corporation
05.1994 - 05.1997
Education
Bachelor of Science - Biology
University of Nebraska
Lincoln, NESkills
- Quality Leadership
- Operational Excellence
- Quality system setup
- Global QA management
- CAPA lifecycle management
- Change Control Governance
- Continuous Improvement
- Lean
- Six Sigma
- GxP Compliance
- Inspection Readiness
- GCP
- Clinical quality systems
- BIMO Readiness
- Inspection hosting
- FDA
- MHRA
- Swissmedic
- FIMEA
- Audit Strategy
- Execution
- Vendor Quality Management
- Supplier Quality Oversight
- CDMO
- CRO
- Global Distributor Compliance
- Warehouse Compliance
- Quality agreement creation
- Audit Compliance
- Regulatory Compliance
- Internal audit management
- External audit management
- GxP vendor audits
- Remediation
- CAPA Effectiveness
- ISO 9001 certification
- ISO 13485 certification
- Self-inspection processes
- Cross-functional teamwork
- Strategic Influence
- Study team representation
- Quality Risk Management
- Stakeholder engagement
- Cross-Functional Alignment
- Clinical
- Safety
- Regulatory
- Manufacturing
- Quality Systems
- Validation
- Technology
- CSV Leadership
- Data Integrity Governance
- QMS Procedure Development
- Process Validation
Certification
- ISO 13485/ISO 9001
- Good Clinical Practice Manager
Highlights Of Relevant Achievements
- Delivered stronger global oversight and reduced compliance risk across Clinical and Commercial operations through building and leading a Compliance QA organization, implementing a risk-based global Vendor Management Program for over 150 GXP vendors, and driving enterprise Inspection Readiness in response to expanding external partnerships and increasing regulatory scrutiny.
- Delivered significant improvements in deviation/CAPA on-time closure (>30-day performance) and strengthened compliance metrics through overhauling change control lifecycle management, optimizing QA operational workflows, and championing Lean/Six Sigma continuous improvement initiatives to address chronic throughput bottlenecks and scale-up documentation readiness.
- Delivered enhanced global product quality and distribution compliance supporting business expansion through directing global qualification, approval, and auditing of third-party distributors, suppliers, and warehouses, ensuring alignment with the Grifols Quality System and mitigating operational and regulatory risks across international markets.
Timeline
Executive Director, Clinical/PV Quality
Exelixis
10.2025 - 06.2026
Executive Director, Compliance QA
Exelixis
11.2021 - 07.2026
Head of Quality Operations
Lonza
04.2020 - 11.2021
Director, Quality Assurance Operations
Grifols
07.2017 - 01.2020
Director, Quality Assurance
Grifols
06.2014 - 07.2017
Director, Alliance Products Quality Assurance
Novartis Diagnostics
02.2011 - 06.2014
Associate Director, Tech Ops Validation (Site Head of Validation)
Novartis Diagnostics
07.2005 - 02.2011
Validation Manager, Blood Testing Division
Chiron Corporation
08.2000 - 07.2005
Senior Validation Specialist, Blood Testing Division
Chiron Corporation
03.1999 - 08.2000
Validation Specialist, Blood Testing Division
Chiron Corporation
05.1997 - 03.1999
Purification Operator, Biopharma Division
Chiron Corporation
05.1994 - 05.1997
Bachelor of Science - Biology
University of Nebraska