Job Title: GMP Compliance Manager or Associate Director
Job Location: Cranbury & South Plainfield NJ
Direct Report: Head of Quality Assurance
Job Summary:
This position will work with cross-functional teams to drive activities that will ensure a state of continuous GMP compliance. This role will also promote and drive compliance by building inspection readiness processes across the organization. This individual will also play a leading role in the preparation and execution of regulatory inspections, client audits and internal audits, as well as follow up post audit/inspection on any items requiring response and action. Specific responsibilities of the position include, but are not necessarily limited to, the items listed below.
Primary Responsibilities:
- Working with department leaders and cross functional teams to educate, build and maintain an inspection readiness structure across the organization
- Leading proactive evaluation and education of site GMP compliance against current and emerging regulatory requirements and trends
- Supporting regulatory inspections and client audits in creating, maintaining and managing inspection content, ensuring it is organized, current and readily accessible at all times
- Responding to incoming enquiries during inspections and audits and ensuring timely and accurate responses
- Evaluating outcomes of regulatory authority inspections/client audits to identify near misses, lessons learned and other best practices and working cross-functionally to ensure identified process or system improvement opportunities are sustainably implemented
- Establishing and maintaining a communication process mechanism to supervisor on the status of inspection readiness and CAPA commitments
- Evaluating and managing proposed commitments to regulatory authorities/audit bodies in response to inspection/audit findings
- Work collaboratively with commitment owners to ensure that all commitment timelines are met via proactive CAPA tracking, and confirm their timely closure and ensure suitable effectiveness checks are in place
- Generating, developing and reporting metrics / trends for program adherence to requirements and effectiveness
- Revise SOPs and quality system designs to implement practices and improvements to make sure site inspection-ready at all times
- Manage and review deviations, change controls, and CAPAs including providing metrics and trending of relevant data
- Building and implementing tools to improve site inspection readiness; determine system improvements through effective project management
- Participating in internal committees/teams, as required
- Cross-site support of inspection readiness and inspection activities
- Other QA duties assigned by supervisor.
Qualifications:
- Education: A minimum of a Bachelor’s degree in a scientific discipline or equivalent experience.
- Experience: Minimum of 5-7 years of experience in GMP compliance within the CDMO or pharmaceutical industry. This role will be considered at different levels depending on experience.
- Technical Skills: Rich knowledge of GMP guidelines, such as ICH Q7, Q9, Q10, ect. and regulatory requirements, such as CFR 21, part 210, 211, and 11. Proficient in using Microsoft Office.