Senior Director, Quality Control (QC Head) β La Verne, CA (based at La Verne facility)
Key Responsibilities
- Lead and oversee all QC functions (analytical, microbiology, raw materials, in-process, drug substance, drug product, stability) across small molecule and biologics.
- Define and execute site QC strategy aligned to global quality and business objectives.
- Ensure support for commercial manufacturing, PPQ, technical transfers, and new product introduction.
- Ensure QC operations meet global GMP requirements and maintain inspection readiness.
- Represent QC during regulatory inspections/audits with strong compliance and data integrity.
- Build technical capabilities (analytical expertise, method lifecycle management, advanced technologies).
- Develop talent via training, knowledge management, and technical succession planning; lead a high-performing QC organization and foster a quality culture.
- Drive QC network harmonization, adoption of global QC policies/systems, and continuous improvement (Lean Laboratory, KPIs, digitalization/automation).
- Partner cross-functionally (Manufacturing, MSAT, QA, Regulatory, Supply Chain) for aligned execution and reliable supply.
Knowledge/Skills
- Experience with commercial manufacturing, PPQ, and technical transfers; global QC initiatives and cross-site collaboration.
- Balance technical rigor, compliance, and business needs; strong people leadership and stakeholder engagement.
Required
- BS + 14+ years OR MS + 12+ years OR PhD + 12+ years in pharma/biopharma with significant QC leadership in GMP environment.
- Deep expertise in analytical sciences/QC across small molecule and biologics; science-based decision making.
- GMP, inspection management, and data integrity (ALCOA+); track record supporting FDA/EMA/PMDA inspections.
- Lean Laboratory and continuous improvement (process optimization, digitalization, automation).
Preferred
- MS or PhD in a scientific discipline.
Benefits/Compensation (as stated)
- Salary range: $221,000.00β$286,000.00; may be eligible for discretionary bonus/LT incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday.