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 at the new Morrisville small molecule manufacturing site. Provide quality leadership for product release, batch record review, and disposition activities while investigating deviations, out-of-expectation results, and complaints to ensure effective corrective actions. Manage resources, capacity planning, and quality metrics to achieve business and compliance objectives, supporting validation, technology transfer, and commissioning of new manufacturing processes. Ensure ongoing inspection readiness by successfully supporting internal, customer, and regulatory audits. Develop and coach high-performing teams while fostering a culture of accountability, utilizing data and technology to support the site's transformation journey in line with Novartis Technical Operations strategy.
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
- Quality
- 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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