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Associate Director Quality Control Jobs in California

Moderna Therapeutics

The Role The Associate Director, Quality Control Lab Automation Strategy & Digital Integration is responsible for leading the strategy, implementation, and lifecycle management of laboratory ...

Marquee Staffing - CB

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Director, Quality Control

Carlsbad, CA · On-site

$195K - $205K/yr

The Director of Quality Control is responsible for leading and managing all aspects of laboratory operations within QC Chemistry and Microbiology programs. This role ensures compliance with Good ...

PCI Pharma Services

Director, QC

San Diego, CA

The role oversees QC Chemistry, Method Transfers,Stability, Raw Materials, and Logistics operations supporting GMP manufacturing, release testing,investigations, and regulatory compliance. This ...

PCI Pharma Services

Director, QC

San Diego, CA · On-site

The role oversees QC Chemistry, Method Transfers, Stability, Raw Materials, and Logistics operations supporting GMP manufacturing, release testing, investigations, and regulatory compliance. This ...

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Associate Director Quality Control information

What are the main challenges an Associate Director of Quality Control typically faces when managing a diverse QC team?

An Associate Director of Quality Control often manages teams with varied technical backgrounds, which can lead to challenges in aligning processes, maintaining consistent training standards, and ensuring clear communication across functions. Balancing the demands of regulatory compliance, tight production timelines, and continuous improvement initiatives is also a common challenge. Successful leaders in this role foster a culture of collaboration, prioritize ongoing training, and implement standardized procedures to help their teams deliver reliable results and support broader organizational goals.

What are Associate Director Quality Control?

An Associate Director of Quality Control is a senior management professional responsible for overseeing the quality control processes within an organization, often in industries like pharmaceuticals, biotechnology, or manufacturing. They lead teams that test and monitor product quality, ensure compliance with regulatory standards, and develop strategies to improve testing procedures. Their role involves managing budgets, mentoring staff, and collaborating with other departments to uphold product integrity. Associate Directors of Quality Control often report to higher-level executives and play a key role in maintaining customer trust and regulatory approval.

What are the key skills and qualifications needed to thrive as an Associate Director of Quality Control, and why are they important?

To thrive as an Associate Director of Quality Control, you need in-depth knowledge of quality management systems, regulatory compliance, and relevant scientific or technical expertise, typically supported by a degree in life sciences or engineering. Familiarity with laboratory information management systems (LIMS), quality assurance software, and certifications such as Six Sigma or ASQ are highly valuable. Leadership, problem-solving, and strong communication skills help drive team performance and foster cross-functional collaboration. These skills ensure rigorous product quality, regulatory adherence, and operational efficiency in quality-driven environments.

What is the difference between Associate Director Quality Control vs Quality Control Manager?

AspectAssociate Director Quality ControlQuality Control Manager
CredentialsBachelor's/Master's in Life Sciences, Quality Certifications (e.g., CQE)Bachelor's/Master's in Life Sciences, Quality Certifications (e.g., CQE)
Work EnvironmentLeadership role in labs or manufacturing facilities, overseeing teamsSupervises QC teams, conducts testing, and ensures compliance
Industry UsageUsed in pharmaceutical, biotech, and biotech manufacturing companiesCommon in similar industries, often reporting to Associate Directors

The Associate Director Quality Control typically holds a higher strategic and leadership role, overseeing multiple teams and ensuring compliance at a broader level. The Quality Control Manager focuses more on daily testing, team supervision, and operational tasks. Both roles require similar credentials but differ in scope and responsibility.

What are popular job titles related to Associate Director Quality Control jobs in California? For Associate Director Quality Control jobs in California, the most frequently searched job titles are:
What job categories do people searching Associate Director Quality Control jobs in California look for? The top searched job categories for Associate Director Quality Control jobs in California are:
What cities in California are hiring for Associate Director Quality Control jobs? Cities in California with the most Associate Director Quality Control job openings:
Associate Director Quality Control jobs near you
Infographic showing various Associate Director Quality Control job openings in California as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

Associate Director, Quality Assurance (GMP QC Lab Oversight)

Coherus Oncology

Camarillo, CA • On-site

Full-time

Posted 23 days ago

Job description

Title: Associate Director, Quality Assurance (GMP QC Lab Oversight)
Reports to: Head of Quality Assurance Operations
Location: Camarillo, CA (On-site)
Classification: Exempt
Overview:
The Associate Director, Quality Assurance provides strategic and operational QA oversight of GMP Quality Control laboratory activities at the Camarillo site and reports to the Head of QA Operations. This role requires a regular on-site presence to effectively support daily GMP QC laboratory operations.
Key responsibilities include ensuring compliant laboratory operations through oversight of laboratory systems, facilities, and the qualification and validation of instruments and equipment. The role is accountable for review and approval of Certificates of Analysis (CoAs) and other GMP documentation, supporting laboratory investigations and batch disposition decisions, and contributing to Quality Management Review processes. The Associate Director also serves as a key partner to QC in driving inspection readiness, continuous improvement, and sustained GMP compliance.
Responsibilities:
  • Provide QA oversight of GMP QC laboratory operations to ensure compliance with cGMP, FDA, and ICH requirements.
  • Oversee QC laboratory systems, instruments, and equipment throughout their lifecycle, ensuring they remain in a validated and inspection-ready state.
  • Review and approve QC-related GMP documentation, including analytical records, CoAs/CoTs, method qualification and validation reports, stability data, deviations, CAPAs, and change controls.
  • Lead and oversee laboratory investigations (e.g., OOS, OOT, deviations, and data integrity events), ensuring robust root cause analysis, appropriate impact assessment, and timely, compliant resolution.
  • Support batch disposition by ensuring QC data, CoAs, investigations, and associated documentation are complete, accurate, and compliant with internal procedures and regulatory expectations.
  • Partner cross-functionally with QC, Manufacturing, Regulatory, and site leadership to ensure compliant laboratory operations, drive continuous improvement, and maintain sustained inspection readiness.
  • Provide QA support and oversight for method transfer, validation, and technical transfer activities impacting QC laboratory operations.
  • Collaborate with Facilities, IT, and QC to support equipment implementation, qualification, maintenance, and resolution of operational issues impacting GMP laboratory activities.
  • Support and participate in internal audits, external audits, and regulatory inspections; contribute to inspection readiness activities and timely, effective responses.
  • Contribute to Quality Management Review processes (e.g., QMR, PQR/APQR), including analysis of QC performance metrics, identification of quality trends, and execution of continuous improvement actions.
  • Escalate significant quality risks and critical issues to the Head of Quality Assurance and senior leadership, as appropriate.
  • Drive development, enhancement, and continuous improvement of SOPs, QA processes, and QC-related quality systems.

Qualifications:
  • Bachelor's degree in a scientific discipline (or equivalent experience) with a minimum of 8 years of direct experience supporting GMP QC laboratory operations in a regulated pharmaceutical or biotechnology environment, including QA oversight.
  • Demonstrated experience in biologics/protein therapeutics, including manufacturing and testing of drug substance, drug product, and finished goods.
  • Demonstrated experience handling QC-related issues, records, and laboratory operations, including analytical documentation, deviations, and investigations, within a GMP environment; prior hands-on QC laboratory experience strongly preferred.
  • Experience reviewing and approving equipment and instrument qualification and validation documentation (e.g., IQ/OQ/PQ), with working knowledge of lifecycle management principles; experience applying risk-based approaches to computerized systems (GAMP 5) preferred.
  • Strong working knowledge of FDA cGMP regulations and ICH guidelines applicable to QC laboratory operations.
  • Experience leading and/or overseeing laboratory investigations, including OOS, OOT, deviations, CAPAs, change control, and data integrity events within a GMP environment.
  • Solid understanding of CoA/CoT generation and approval, and experience supporting batch disposition decisions in a GMP setting.
  • Demonstrated experience supporting internal audits, external audits, and regulatory inspections, including inspection readiness and response activities.
  • Strong written, verbal, and interpersonal communication skills, with the ability to effectively influence cross-functional teams.
  • Proven ability to exercise sound judgment, prioritize effectively, and operate successfully in a fast-paced, on-site GMP environment.

Additional requirements
  • On-site presence in Camarillo is required to support daily GMP QC laboratory operations.
  • Up to 20% travel may be required to support audits, external laboratories, or business needs.

The Base Salary Range for this position is $170,000 to $200,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.
Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.

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