QA Operations Head (Associate Director)
$138,600–$257,400 year
On-siteDurham, North Carolina, United States
Job Summary
Lead Quality Operations oversight to ensure compliance across manufacturing activities and drive operational excellence for product release, batch record review, and disposition. Investigate deviations, out-of-expectation results, and complaints while managing resources, capacity planning, and quality metrics. Support validation, technology transfer, and commissioning for new manufacturing processes, ensuring ongoing inspection readiness for internal, customer, and regulatory audits. Coach high-performing teams and champion continuous improvement initiatives to strengthen quality performance and regulatory compliance at the new Morrisville small molecule manufacturing site.
Required Qualifications
- Bachelor of Science or Master of Science in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related scientific discipline
- advanced degree
- Minimum 8-10 years of relevant pharmaceutical experience
- direct experience in oral solid dosage manufacturing
- expert roles in Production, Manufacturing Science and Technology and/or Engineering
- Demonstrated Quality Operations leadership experience
- responsibility for product release
- compliance
- inspection readiness
- people leadership
- talent development
- performance management
- cross-functional collaboration
- Experience with Heath Authority inspections (preferably FDA)
- regulatory procedures
- Proven experience leading deviation investigations
- corrective and preventive actions
- validation activities
- continuous improvement initiatives
Desired Qualifications
- Previous involvement with facility start-ups
- qualifications
- validations
- transfers
- Qualifications or certification in Lean Management
- Operational Excellence
- continuous improvement methodologies
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