KAREEM SYED
Quality Assurance & Compliance Leader | GCP, GMP, GLP, GVP | Pharma, Biotech & MedTech
Saratoga,CA
Summary
Accomplished biopharma and technology compliance leader with 15+ years of experience driving global QA, GxP compliance, and regulatory inspection readiness across pharmaceutical, biotech, and medical device industries. Proven expertise in GMP, GCP, GLP, and GVP audit management, with a strong record of partnering with R&D, clinical, and manufacturing teams to ensure regulatory compliance and product quality. Adept at building inspection-ready programs, implementing modern Quality Management Systems (QMS), and guiding cross-functional teams through FDA, EMA, and MHRA inspections. Experienced in advising on cybersecurity audit automation and leveraging AI technologies to modernize compliance practices. Holder of an active federal security clearance and committed to transforming regulatory obligations into strategic organizational advantages.
Overview
16
16
years of professional experience
6
6
Certifications
Work History
Associate Director, Quality Assurance – Global GCP/GLP/GVP Compliance & Audit Management
Exelixis
Alameda, CA
10.2023 - Current
- Spearhead global GVP, GCP, and GLP audit programs, ensuring compliance and inspection readiness.
- Mentor and develop global QA teams, fostering a culture of compliance and excellence.
- Lead adoption of Veeva Vault, LMS, and modernized compliance processes.
- Ensure inspection readiness for FDA, EMA, and MHRA regulatory bodies.
Advisor, Cybersecurity & Audit Automation
Ditan.ai
Campbell, CA
01.2024 - Current
- Advise on design and training of cybersecurity audit automation tools.
- Provide strategic insights on compliance frameworks, enhancing AI adoption and risk management.
- Support cross-functional collaboration to align with industry standards.
- Part-time
Manager, QA Training & Compliance
Penumbra, Inc.
Alameda, CA
08.2021 - 10.2023
- Developed and implemented inspection readiness programs across the organization.
- Launched validated LMS, streamlining QA training and compliance.
- Designed and executed mock audits, boosting FDA/global inspection readiness.
- Supported CAPA oversight and regulatory follow-up for continuous improvement.
Consultant, Compliance & Security Audits (Federal Clearance)
Vianova Security
Arlington, VA
06.2020 - Current
- Conduct comprehensive FISMA audits for U.S. federal agencies under federal clearance.
- Provide expert compliance strategies and risk management frameworks.
- Developed automation strategies, reducing audit preparation time by 30%.
- Consultant
Founder, Medical Transcription AI
Ritn.ai
Saratoga, CA
01.2021 - 06.2022
- Founded and led health-tech startup focused on AI-powered medical transcription.
- Directed product strategy, prototyping, and investor/clinician engagement.
- Gained experience in product-market fit, competition strategy, and operations scaling.
Civil Grand Juror
County of Santa Clara
Santa Clara, CA
12.2019 - 12.2020
- Investigated public agencies and officials, promoting transparency and accountability.
- Authored formal reports to strengthen government efficiency and compliance.
- Gained governance and civic engagement insights, enhancing analytical skills.
Multiple Roles
Thermo Fisher Scientific
Fremont, CA
08.2009 - 04.2019
- Business Development Account Manager – Life Sciences (2016 – 2019)
- Managed global accounts driving $15M+ revenue growth, aligning solutions with compliance needs.
- Supported international certifications ensuring readiness for regulatory markets.
- Partnered with R&D and QA to translate innovations into compliant solutions.
- OEM Account Manager / Materials Planning Supervisor (2013 – 2016)
- Oversaw supply chain operations and compliance for life sciences components.
- Achieved 100% on-time delivery for strategic accounts.
- Chaired Materials Review Board to optimize quality/compliance.
- R&D Scientist II – Monoclonal Antibodies (2009 – 2013)
- Led antibody development projects from design through scale-up.
- Delivered regulatory/commercially viable scientific outputs.
- Ensured GxP compliance in research environments.
Education
Bachelor of Science - Applied Sociology
Santa Clara University
Santa Clara, CA06.2002
Master of Arts - Philosphy And Religion
Chicago Theological Seminary
Chicago, IL 05.2001 -
Websites
Certification
Qualified & Trained Auditor – GVP, GCP, GLP
Timeline
Advisor, Cybersecurity & Audit Automation
Ditan.ai
01.2024 - Current
Associate Director, Quality Assurance – Global GCP/GLP/GVP Compliance & Audit Management
Exelixis
10.2023 - Current
Manager, QA Training & Compliance
Penumbra, Inc.
08.2021 - 10.2023
Founder, Medical Transcription AI
Ritn.ai
01.2021 - 06.2022
Consultant, Compliance & Security Audits (Federal Clearance)
Vianova Security
06.2020 - Current
Civil Grand Juror
County of Santa Clara
12.2019 - 12.2020
Multiple Roles
Thermo Fisher Scientific
08.2009 - 04.2019
Master of Arts - Philosphy And Religion
Chicago Theological Seminary
05.2001 -
Bachelor of Science - Applied Sociology
Santa Clara University
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