About this role
Role Overview
- Report to the Head of Global Compliance.
- Ensure overall cGMP compliance profile is maintained.
- Develop and implement compliance processes and systems consistent with global quality systems requirements.
- Engage with key global regulators to assure that practices and policies meet current regulatory expectations.
- Support the established Quality Compliance strategy.
- Work on continuous improvements regarding national and international cGMP compliance standards.
- Develop and execute inspection readiness programs.
- Provide guidance on compliance-related matters.
- Develop education training regarding regulatory requirements.
Requirements
- Degree in Chemistry, Biotech, Pharmacy or equivalent.
- 12+ years of cGMP experience in a global pharmaceutical industry.
- Experience with regulatory authorities from an auditing perspective in a pharmaceutical GMP environment.
- Experience with remediation, interpersonal build or transformational work is highly preferred.
- Knowledge and experience with quality assurance functions.
- Capability to network within the pharmaceutical industry and partner strategically with international regulators.
- Capability to collaborate and effectively communicate under pressure.
- Up to 50% domestic and international travel.
Benefits
- Health insurance
- 401(k) matching
- Paid time off
- Professional development opportunities