Responsibilities
- Lead audit readiness program and maintains regulatory requirements for Facilities and Engineering department
- Interface regularly with Quality Assurance, Manufacturing and other departments to facilitate decisions pertaining to quality system deliverables
- Responsible for specifying and coordinating training, development, and compliance for Engineering Compliance personnel
- Work closely with Quality and Regulatory groups for the Facilities and Engineering departments to address potential compliance issues
- Provide primary support for all regulatory and partner audits and inspections
- Develop, track, and maintain Facilities and Engineering department metrics for presentation to site leadership.
Requirements
- Bachelor’s Degree in Science or Engineering and a minimum of 3 years of quality and compliance experience in the pharmaceutical manufacturing industry
- Demonstrated proficiency and knowledge of CGMPs, industry validation practices, and change control practices
- Demonstrated ability to effectively write technical documents, including test plans, protocols, and reports
