Director of Commercial Quality Assurance

The Director of Commercial Quality Assurance plays a key role in fostering a culture of quality, efficiency, and excellence, ensuring quality and compliance are integrated into day-to-day operations and long-term Quality strategy.

Requirements

• General knowledge of aseptic manufacturing processes
• Expert knowledge of GMP guidelines and Quality expectations for preclinical and clinical phase programs
• In-depth understanding and application of cGMP principles, concepts, practices, and standards
• Experience with regulatory inspections by the FDA and EU authorities
• Ability to influence diverse stakeholders and drive accountability and decision-making cross functionally
• Demonstrated ability to partner with other functional groups to achieve business objectives
• Broad knowledge of FDA and international regulations related to GMPs and Pharmaceuticals
• Experience organizing and managing work responsibilities while working independently with minimal oversight
• Time and project management skills with the ability to multi-task and meet deadlines
• Excellent verbal and written communication skills
• Excellent organizational skills and attention to detail
• Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside of the company
• Accepts feedback from a variety of sources and constructively manages conflict
• Strong analytical and problem-solving skills
• Proven ability to lead organizations
• Ability to prioritize tasks and to delegate when appropriate
• Proficient with Microsoft Office Suite or related software

Benefits

• Over four weeks of paid time off annually
• Employer contributions to a retirement account
• Various health plans with minimal employee contributions
• Basic life and long-term disability coverage
• Employee Assistance Program
• Pet insurance