Join a leading manufacturer as the Quality Systems Manager to implement and oversee the daily activities of their FDA-regulated Tennessee facility!
Responsibilities:
- Managing and supporting deviation/non-conformance investigations and processes.
- Overseeing the trending, reporting, and investigations of the Customer Complaint process.
- Managing the Product Release Program, batch record review process, metrics, and customer CofAs.
- Leading Annual Product Reviews and Quarterly Management Reviews.
- Supervising the change control and metrics of the Document Control program.
- Creating and revising quality documents related to job accountabilities.
- Managing the training, system development, and metrics of the Internal Auditing program.
- Collaborating closely with QA operations, QA lab, and manufacturing operations to develop and maintain quality systems and processes, ensuring regulatory compliance.
- Acting as a key participant in regulatory inspections, Customer, and 3rd party audits. Managing Cost of Quality.
- Developing and mentoring direct reports.
Qualifications:
- Bachelor's degree in Chemistry, Microbiology, Biology, Engineering, or other related discipline. Advanced degree preferred.
- 7 years minimum in the pharmaceutical, medical device, or other FDA-regulated industry, with at least 3 years of leadership/advisory experience.
- 5+ years interfacing with regulatory agencies (e.g., FDA, TGA).
- Prior experience with root cause analysis, risk analysis methods, leading investigations, managing audits, regulated document systems, change management, complaint management, and non-conformance/deviation management.
