Director of Commercial Quality Assurance

The Director of Commercial Quality Assurance plays an integral role in fostering a culture of quality, efficiency, and excellence, ensuring that quality and compliance are integrated into the day-to-day operations and long-term Quality strategy. The focus of this position will be to support the Commercial Manufacturing Facility that is currently underway, giving the selected candidate the ability to truly be a visionary leader in the development and implementation of the Commercial Quality Assurance program.

Requirements

• General knowledge of oral solid dosage manufacturing processes
• Experience with Commercial Manufacturing oversight, with a preference for those who have built and developed programs
• Expert knowledge of GMP guidelines and Quality expectations for late-phase and commercial programs
• In-depth understanding and application of cGMP principles, concepts, practices, and standards
• Experience with regulatory inspections by the FDA and EU authorities
• 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
• Strong analytical and problem-solving skills
• Proven ability to lead organizations
• Ability to prioritize tasks and to delegate when appropriate

Benefits

• Paid Time Off
• Retirement Plan
• Health Plans
• Life Insurance
• Disability Insurance
• Employee Assistance Program
• Pet Insurance