Associate Director of Quality Assurance Operations
INCOG BioPharma ServicesFishers, Indiana, United States
Posted March 12, 2025
Full Time
About the Company
INCOG BioPharma Services specializes in injectable drug product formulation development, analytical method development, process scale-up, and formulation & filling of vials, syringes, and cartridges. The company also offers customized packaging services including labeling, device assembly, final packaging, and integrated storage solutions at various temperature conditions. INCOG's expertise lies in providing comprehensive pharmaceutical solutions that meet the highest quality standards.
Job Description
The Associate Director of QA Operations will drive Quality Mindset and foster efficiency, precision, and timely delivery. The role involves strengthening operational performance, ensuring adherence to quality standards, and collaborating with cross-functional teams to improve processes and ensure product quality. A strong team player and communicator are crucial, requiring expertise in GMP compliance, regulatory scrutiny, and process improvement.
Requirements
- Lead and manage a QA Operations group across three shifts, 24/5
- Ensure compliance with quality standards and regulatory requirements
- Train, mentor, and develop QA team members
- Prioritize and coordinate QA resources for efficient product manufacture
- Lead strategy and direction of the QA team
- Develop and maintain room/line clearance processes
- Manage deviation investigations
- Ensure safety compliance
Benefits
- Competitive salary
- Comprehensive benefits package
- Opportunity for professional development
