Director, Quality Control Manufacturing Support
Evonik · Lafayette, IN · 6 days ago
Quality AssuranceFull-time
Job Summary
The Director, QC Manufacturing Support leads a team of approximately 40 employees responsible for Quality Control and Environmental Analytical Services supporting pharmaceutical intermediate and API manufacturing. This role oversees laboratory operations, employee development, regulatory compliance, quality, and operational performance across QC testing, environmental testing, lab informatics, stability, and technical data review to ensure safe, efficient, and cGMP-compliant operations.
Responsibilities
- Ensure laboratory operations remain fully compliant with all applicable regulatory and safety requirements (cGMP, OSHA, etc.) while promoting operational excellence and continuous improvement of supporting processes and systems.
- Lead, develop, and retain a diverse team by fostering a challenging, open, and honest work environment; maintain responsibility for hiring, terminations, career development, performance management, merit increases, promotions, and resolving personnel issues for approximately 40 employees.
- Design and support career growth opportunities for laboratory technicians and scientists with diverse educational backgrounds while aligning individual objectives with team and department goals.
- Serve as a member of the Site Quality Leadership Team to help implement the strategic vision for Quality operations.
- Build strong relationships with customers by effectively communicating and influencing improvements in product control strategies and routine workflow management.
- Hold teams and individuals accountable for action plans, timelines, and performance results.
- Develop and maintain operational metrics to monitor laboratory efficiency, capacity, and overall performance.
- Participate in technical discussions to ensure operational excellence is balanced with quality and safety requirements.
- Plan for and maintain accountability for departmental financial metrics.
- Benchmark laboratory operations against internal Evonik sites and industry peers to identify and implement best practices.
Requirements
- Bachelor's degree in Chemistry, Engineering, Science, or equivalent experience required.
- 15+ years of industrial experience, including 5–7 years working in a GMP environment.
- Extensive knowledge of GMP compliance across a wide range of products, including APIs, food additives, excipients, and related products, with the ability to apply compliance standards to daily production activities.
- Strong leadership, communication, and people management skills.
- Ability to work effectively in a dynamic or undefined environment while driving operational excellence and continuous improvement.
- Must be willing to provide 24/7 support for assigned areas and work nights and weekends as needed.