Related skills
risk management audits ich gmp sop📋 Description
- Assess and optimize Quality systems for CMC, Clinical, Regulatory, and IT.
- Drive cross-functional adoption and performance of Quality systems.
- Provide strategic support for product supply integrity and global GMP compliance.
- Partner with cross-functional leadership for integration with corporate systems.
- Represent Quality in internal and external forums; lead cross-functional teams.
- Use Continuous Improvement tools to improve QMS delivery and quality.
🎯 Requirements
- Bachelor's degree in biological sciences or related field.
- 13+ years in pharma with Quality systems experience.
- Expert knowledge of multi-regional regulatory requirements (ICH/US/EU).
- Ability to read, analyze, and interpret standards and regulatory guidance.
- Strong organizational, leadership and cross-functional skills.
- Experience coaching/mentoring and strong communication.
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