Senior Director Quality Affairs
On-siteShirley, New York, United States
Job Summary
Lead a multi-disciplinary team overseeing sterile injectable production phases, including laboratory operations, documentation, and regulatory compliance. Manage the Quality Management system for deviations, CAPA, change control, and document management while ensuring site-wide cGMP adherence to 21 CFR Parts 210 and 211. Direct oversight of regulatory authority inspections, customer audits, and continuous improvement initiatives through statistical methodology. Provide leadership for QA Operations, Inspection, and Finishing teams to assure timely oversight of manufacturing, filling, and packaging activities. Own Quality Control labs for stability, chemistry, microbiology, EM, and particulate analysis. Collaborate cross-functionally with Production, Regulatory Affairs, Engineering, and R&D to implement new technologies and harmonize policies across domestic and international locations.
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
- Understands 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
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