VP of Quality
Vice President of Quality - Confidential Biologics CDMO
📍 Location: Fremont, CA - On-site
🧪 Industry: Biologics / Drug Substance Manufacturing
A fast-growing, innovation-driven Contract Development and Manufacturing Organization (CDMO) specializing in biologics is seeking a visionary Vice President of Quality to lead its Quality Compliance function. This executive role is ideal for a seasoned leader with deep expertise in GMP environments, biologics, and drug substance manufacturing-particularly monoclonal antibodies and microbial systems such as E. coli.
About the Opportunity:
This is a pivotal leadership position responsible for overseeing all aspects of Quality Assurance, Quality Control, and Quality Systems. The VP of Quality will be instrumental in shaping the company's compliance strategy, driving operational excellence, and ensuring readiness for clinical and commercial manufacturing. The role offers the chance to influence the future of biologics development in a dynamic, agile environment backed by global investment.
Key Responsibilities:
- Lead and evolve the company's Quality Compliance strategy across GMP operations.
- Serve as the final decision-maker for product quality and compliance, including release of materials, intermediates, drug substance, and drug product.
- Oversee internal and external audits, inspection readiness, and regulatory interactions.
- Drive continuous improvement across QA, QC, and Quality Systems, including CAPAs, deviations, change controls, and risk management.
- Provide strategic oversight of vendor quality, including audits, agreements, and batch disposition.
- Support cross-functional teams through all phases of product development, from clinical to commercial readiness.
- Build and mentor a high-performing quality team, fostering a culture of excellence and accountability.
- Collaborate with technical operations, regulatory affairs, and analytical development to ensure robust quality support.
- Lead EH&S and contribute to expansion into new modalities such as viral vectors and PDNA.
Ideal Candidate Profile:
- 20+ years of progressive leadership in Quality Compliance within GMP-regulated environments.
- Extensive experience in biologics and drug substance manufacturing, including monoclonal antibodies and E. coli systems.
- Strong understanding of CDMO operations and commercialization requirements.
- Proven ability to lead large teams, manage complex quality systems, and influence cross-functional stakeholders.
- Expertise in analytical method validation, stability testing, and regulatory compliance.
- Advanced degree in a relevant scientific discipline (Pharmaceutics, Biochemistry, Biochemical Engineering, etc.).
- High ethical standards, sound judgment, and exceptional communication skills.
If you believe you're a strong fit for this opening, please apply.
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