What are the responsibilities and job description for the Regulatory Compliance Expert position at Zenith LifeScience?
About this Opportunity
Zenith LifeScience is seeking a Regulatory Compliance Expert to join our team. In this role, you will be responsible for ensuring the company's Quality Systems comply with applicable regulations, including GMP's and CGMP's.
You will work closely with Quality System personnel in other Company sites to maintain and improve Quality Systems, serving as a subject matter expert for GMP and DI requirements.
Key Responsibilities
- Maintain and improve Quality Systems for the Americas Region to ensure ongoing compliance with applicable compendia, GMP's, and regulatory guidance.
- Provide expert reviews to ensure records, documents, and Quality Systems meet GMP and DI requirements.
- Support external and internal audits for the Company Americas sites.
- Contribute to the oversight of Quality Systems core responsibilities by trending quality metrics for Company Americas sites.
Requirements
- Bachelor's degree (preferably in a science-related discipline).
- 5-7 years of experience working with Quality Systems (Deviation, Change Control, CAPA, audit, etc.).
- Demonstrated proficiency and experience in working with Quality Systems IT applications.
- Training within a regulated Pharmaceutical/biotech/medical device environment.
- Understanding and application of CGMP's (EU, JP, US).
- Detailed knowledge and application with electronic Quality Systems (e.g., TrackWise, Documentum).
