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Job description
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
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Worksite address
tustin, CA, 92681, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.