Director, Quality Control Analytical Sciences & Technology
Lead Analytical Excellence in Biopharmaceutical Quality Control
Great opportunity for experienced Quality Control leaders with strong analytical sciences expertise in GMP biologics manufacturing
Are you passionate about analytical method lifecycle management, scientific leadership, and quality excellence? We're looking for a Director, Quality Control Analytical Sciences & Technology to lead analytical strategy and provide scientific oversight for Quality Control operations supporting clinical and commercial biopharmaceutical manufacturing.
If you thrive in a data-driven, highly regulated environment and enjoy solving complex analytical challenges while leading high-performing teams, this could be your next opportunity.
What You'll Do
- Lead the lifecycle management and governance of GMP analytical methods to ensure they remain fit-for-purpose and compliant throughout their operational lifecycle
- Serve as the scientific leader for complex OOS, OOT, deviation, atypical result, and recurring invalid assay investigations
- Drive root cause investigations, corrective actions, risk mitigation strategies, and analytical continuous improvement initiatives
- Oversee analytical performance monitoring programs, statistical trending, dashboards, and management reviews
- Establish and maintain analytical control strategies, method governance processes, and performance metrics
- Lead and develop the Analytical Sciences & Technology team, ensuring effective resource allocation and succession planning
- Partner with QC Operations, Analytical Development, MS&T, QA, Regulatory Affairs, and clients on analytical strategy and issue resolution
- Serve as the analytical SME during audits, inspections, regulatory submissions, client interactions, and strategic business initiatives
What We're Looking For
- B.S. in Chemistry, Biochemistry, Biology, or a related scientific field required; M.S. or higher preferred
- Minimum 10 years of industry experience in a QC or analytical laboratory
- Experience with analytical testing and equipment, writing reports, procedures and specifications, GMP environments, and regulatory audits
- Quality Control
- Analytical Sciences & Technology
- Analytical Testing
- Laboratory Instrumentation
- GMP Compliance
- OOS/OOT Investigations
- Deviation Management
- Method Lifecycle Management
- Statistical Trending
- Regulatory Compliance
- FDA Guidelines
- USP
- EP
- EU Annexes
- ICH Guidelines
Base Salary: $163,000 - $204,000 annually , depending on experience and qualifications.
Additional compensation and benefits package available
Please Note
- On-site in Tustin, CA
- Full-time leadership position supporting biopharmaceutical Quality Control operations
- Schedule is typically Monday through Friday, with overtime and weekend support as business needs require
- Occasional overnight travel may be required for conferences, seminars, or client meetings
Director, Quality Control Analytical Sciences & Technology in tustin at Unknown Company
This position is listed as full time and onsite.