Associate Director, Quality Assurance

This is a fully remote position, open to applicants in Kentucky, +12 more states.

📋 Description

• Act as the team leader for internal QA team members.

• Oversee QA activities for CDMO and internal processes, ensuring adherence to regulatory and GMP standards as well as established Quality Agreements.

• Assist in and uphold vendor assessment initiatives.

• Manage quality oversight of vendors through risk-based decision-making during manufacturing and testing processes.

• Facilitate quality performance and ongoing improvement initiatives.

• Supervise the quality of services from third-party suppliers, including manufacturing, filling, packaging, and shipping when necessary.

• Maintain consistent oversight through regular monitoring, auditing, and reviews of Quality Agreements.

• Handle Data Verification tasks to ensure data integrity and compliance with GDP.

• Recognize opportunities for enhancing quality systems and clinical-to-commercial operational procedures and drive their implementation to completion.

• Create, track, and report on quality metrics and KPIs to support Quality Management Reviews.

• Assist with quality systems, including internal and external deviations and changes controls.

• Evaluate product, compliance, and operational risks while collaborating with cross-functional teams to formulate and implement risk management strategies.

• Review and authorize controlled documents.

• Execute additional responsibilities as assigned.

⛳️ Requirements

• Bachelor's degree in Biology, Chemistry, or another relevant scientific field is preferred.

• 8-10 years of cGMP Quality Assurance experience in cell therapy, biologics, and/or small molecule programs.

• Over 5 years of experience managing a team of direct reports within QA.

• Experience in commercial QA is advantageous.

• Travel may be required up to 35% of the time.

• Familiarity with eQMS (e.g., ACE, TrackWise) is essential.

• Solid understanding of current industry practices and standards in an FDA-regulated biotechnology company.

• Exceptional record-keeping and documentation abilities.

• Strong verbal and written communication skills, capable of presenting information clearly in cross-functional environments.

• Experience collaborating with CDMOs is preferred.

• Proficient in using MS Office applications.

• Ability to quickly adapt to a changing environment and circumstances requiring flexibility, tolerance, and a strong sense of urgency while ensuring compliance with all cGMP and regulatory requirements.

• Capacity to work effectively both independently and as part of a team.

🏝️ Benefits

• Comprehensive health insurance coverage for employees and their families.

• 401(k) matching program.

• Employee Assistance Program (EAP).

• Flexible Spending Account (FSA).

• Generous Paid Time Off (PTO) policy.

• Paid parking facilities.

• Subsidized commuter passes.

• In-office catered lunches.

• Team-building events.

• Opportunities for community engagement projects.

• Competitive compensation packages.