Job Description

Role Title: Associate Director, Quality Control

Location: Vacaville

Department: QC

Reports to: Senior VP of Quality

FLSA- Exempt

Salary Range - $160K-$175K

Role Summary

The Associate Director, Quality Control plays a key leadership role in developing and sustaining cGMP-compliant laboratory systems. This individual will oversee quality control operations, including analytical and microbiological testing, as well as daily QC laboratory activities. They will also support method development and validation in collaboration with the analytical development team.

The role involves establishing effective processes, optimizing resources, and ensuring timely product release for both in-house and contract manufacturing (CDMO) products. Success in this position requires a strong foundation in cGMP practices, the ability to lead cross-functional teams, and a commitment to continuous improvement, open communication, and data-driven decision-making.

Key Responsibilities

• Provide strategic and technical leadership for QC functions, including physicochemical, biological, and microbial testing.
• Collaborate with cross-functional stakeholders to maintain compliant, efficient, and high-quality QC operations.
• Lead implementation and qualification of new laboratory equipment and systems, including documentation and compliance processes.
• Manage all aspects of QC testing, including scheduling, sample management, documentation review, and data interpretation to ensure high-quality outputs.
• Develop and oversee project plans, lead meetings, and track progress, issues, and resolutions in a timely manner.
• Support regulatory submissions (e.g., IMPD, BLA) through data generation and documentation.
• Contribute to the development of control strategies for analytical and microbiological testing across product life cycles.
• Serve as subject matter expert (SME) in analytical and microbiology methods and work collaboratively with development, manufacturing, regulatory, and quality teams.
• Build and maintain effective partnerships with CDMOs and CROs to ensure quality standards and timelines are met.
• Support method transfers and validations in collaboration with internal and external stakeholders.
• Oversee QC documentation and quality events (e.g., deviations, investigations, and change controls).
• Ensure compliant and structured change control processes throughout project execution.
• Represent QC during FDA and other Health Authority inspections, audits, and prepare or support related responses.
• Recruit, develop, and lead a high-performing, inclusive, and collaborative QC team.
• Provide ongoing feedback, coaching, and development opportunities to team members.
• Identify and implement opportunities for process improvements and efficiencies.
• Champion a culture of quality, accountability, and compliance throughout all operations.

Required Skills

• Demonstrated expertise in maintaining cGMP-compliant QC and stability laboratories.
• Strong understanding of current Good Manufacturing Practices (cGMPs) and regulatory expectations.
• Proven ability to prioritize work, allocate resources effectively, and manage complex schedules.
• Clear and professional communication skills, both written and verbal, with the ability to convey complex information to varied audiences.
• Adaptability and problem-solving abilities, with a focus on meeting organizational goals.
• Prior leadership experience with direct supervision and team development.
• Proficient in analytical techniques, method validation, and regulatory quality systems.
• Experience supporting or leading FDA and other Health Authority inspections, including the preparation and management of inspection-related documentation and responses.
• Commitment to quality-focused practices, accurate documentation, and team collaboration.

Qualifications

• Bachelor’s degree in a scientific discipline (e.g., biology, biochemistry, chemistry) with 12+ years of relevant cGMP laboratory, team leadership, and FDA/Health Authority inspection experience.
• Master’s degree in a scientific discipline with 10+ years of relevant cGMP laboratory, team leadership, and FDA/Health Authority inspection experience.
• Ph.D. in a scientific discipline with 7+ years of cGMP laboratory, team leadership, and FDA/Health Authority inspection experience.

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