Senior Director Quality Affairs
On-siteNew Albany, Ohio, United States or Columbus, Ohio, United States
Job Summary
Oversee and direct all aspects of compliance for sterile injectable manufacturing, including laboratory operations, documentation, and regulatory body inspections. Provide leadership for a professional team managing quality management systems, deviation investigations, CAPAs, change controls, and continuous improvement processes. Execute production records, approve batch releases, and ensure site-wide cGMP compliance with 21 CFR Parts 210/211 and USP requirements. Manage regulatory authority inspections, customer audits, and cross-functional activities with internal and external stakeholders. This role requires a Bachelor's in Life Science with 15+ years in pharmaceutical operations and 10+ years leading QA/QC functions. Full-time position with 10% travel; ability to work off-hours and weekends as needed. American Regent, a top-10 injectable manufacturer, supplies branded and generic specialty injectables for healthcare and veterinary markets across the US and Canada.
Required Qualifications
- Bachelors in Life Science or equivalent course of study
- Minimum 15 years progressive experience in pharmaceutical operations and interactions with regulatory agencies
- Minimum 10 years leading functional quality assurance; quality control, compliance, or manufacturing operations
- Expertise across multiple areas including developing quality system requirements for cGMP compliance of pharmaceutical drug production and laboratory facilities
- Validation for pharmaceutical manufacturing facility
- Understand the standards and principles of Compliance and Quality Assurance including the specific regulatory requirements and techniques of examining, questioning, evaluating and reporting to determine a quality system's adequacy and deficiencies
- Must have a thorough understanding of applicable regulations/guidelines/expectations and have a proven ability to apply them to a Pharmaceutical environment
- Proven excellence in written and verbal communication skills
- Proven record of exceptional people and program management skills
- Ability to work independently and deliver timely results
- Ability to work off hours and weekends as needed
- Able to travel 10% of the time
- Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves
- PPE is essential for the health and safety of employees
Desired Qualifications
- Master's Degree is a plus
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