Associate Director, Quality Assurance (Operations)

The Associate Director, Quality Operations will lead quality operations and compliance across the company's GxP activities, with a primary focus on GMP operations, and cGMP readiness in support of CGT and LVV manufacturing.

What You Will Do

The role will oversee quality aspects of starting material, intermediates, drug substance and drug product manufacturing, review and approve specifications affecting product quality, and ensure effective CAPA management.

Why It Might Be a Fit

The role requires strong leadership skills, demonstrated success in managing a team, and in-depth knowledge of the regulatory environment (FDA, ICH, EU) for the manufacture of medicinal or investigational products.

Requirements

• Bachelor's Degree in life science or engineering
• A minimum of eight years' leadership experience in Quality Assurance, cGMP Compliance, or related fields in biopharmaceutical products
• In-depth knowledge of the regulatory environment (FDA, ICH, EU) for the manufacture of medicinal or investigational products, specifically aseptically filled products
• Strong leadership skills and demonstrated success in managing a team
• Knowledge of the Contract Manufacturing business is preferred. Experience with biologics is preferred
• Demonstrated expertise in inspection readiness, regulatory inspections, and inspection response management, including FDA Form 483 responses, commitments, and remediation strategies
• To perform this job successfully, an individual should have knowledge Excel spreadsheet software and MS Word Processing software and SAP knowledge is a plus

Benefits

• Comprehensive benefits package, including health, vision, and dental insurance
• 401(k) plan