Senior Director of Quality Control

Asahi Kasei

. Lead Bionova Scientific’s QC function and set strategy for QC operations.

Posted 9/15/2026full-timeFremont • California • United StatesSenior💰 $240,000 - $280,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Control leadership, analytical method development, and compliance with cGMP standards. Proven ability to drive continuous improvement and effectively communicate across teams in a biopharmaceutical environment.

Highest-signal resume keywords

Leadership Experience in Analytical SciencesCGMP Compliance ExpertiseMethod Development and ValidationRegulatory Agency InteractionBiopharmaceutical Development Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Analytical Methods ExpertiseMethod OptimizationMethod TransferMethod QualificationMethod ValidationStability TestingRelease TestingData IntegrityQuality Control OperationsContinuous Improvement Initiatives

Soft Skills

Team LeadershipCoachingStrategic CommunicationRisk AssessmentCollaboration

Industry Keywords

PharmaceuticsBiochemistryBiochemical EngineeringGMP Laboratory EnvironmentGlobal Regulatory AgenciesBiopharmaceutical DevelopmentEnvironmental Monitoring ProgramsQuality AssurancePerformance MetricsKPI Management

About the role

Key responsibilities & impact

Lead Bionova Scientific’s QC function and set strategy for QC operations.
Provide strategic and tactical leadership for QC laboratories and related operations.
Apply analytical methods expertise to development, clinical, and commercial testing, including troubleshooting and investigations.
Ensure phase-appropriate compliance with global cGMP expectations for release, stability, and environmental monitoring programs.
Partner with clients and internal teams to assess program risks and define analytical strategies.
Oversee method development, transfer, qualification, and validation for development and commercial programs.
Partner with Quality Assurance to maintain fit-for-purpose QC quality systems and data integrity.
Drive continuous improvement initiatives, performance metrics, and KPIs.
Lead, coach, and develop the QC team.
Communicate goals, risks, decisions, and results across development and commercial teams.

Requirements

What you’ll need

Advanced degree in Pharmaceutics, Biochemistry, Chemistry, Biochemical Engineering, or a related discipline; equivalent experience may be considered.
15+ years of leadership experience in Analytical Sciences, Quality Control, or a related GMP laboratory environment.
Strong understanding of biopharmaceutical development, from cell line generation through market authorization.
Direct experience interacting with global regulatory agencies.
Strong experience with method optimization, transfer, qualification, and validation for release and stability testing.
Extensive knowledge of cGMP requirements and data integrity expectations.

Benefits

Comp & perks

Direct Hire
Medical, Dental, Vision
401K (match up to 5%, plus an additional 3%, total 8%)
Paid time off
Annual Bonus eligible