Quality Affairs Sr Director
On-site · New Albany, Ohio, United States
Job Summary
The Quality Affairs Sr. Director is a strategic leader responsible for ensuring compliance and excellence in quality across production and testing of various pharmaceutical products. This role includes leadership of a professional team, managing quality systems such as CAPA and change control, and ensuring cGMP compliance. Key duties involve overseeing regulatory audits, continuous quality improvement initiatives, and maintaining effective communication with regulatory agencies. The position requires a Bachelor's in Life Science, with a preference for a Master's, and extensive experience in pharmaceutical quality assurance and regulatory interactions.
Required Qualifications
- Minimum 15 years progressive experience in pharmaceutical operations and interactions with regulatory agencies
- Minimum 12 years leading functional quality assurance, quality control, compliance, and manufacturing quality operations
- Expertise across multiple areas leading quality system requirements for cGMP compliance of pharmaceutical drug production and laboratory facilities
- Thorough understanding of applicable regulations/guidelines/expectations and ability to apply them in a Pharmaceutical environment
- Exceptional written and verbal communication skills
- Strong people and program management skills
Desired Qualifications
- Master’s Degree in Life Science or related field
Additional Requirements
- Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status
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