Associate Director, GMP Quality Assurance - Qualified Person

Olema Oncology is seeking an Associate Director, GMP Quality Assurance - Qualified Person to ensure Clinical and Commercial medicinal products are manufactured, tested, and released in compliance with EU regulatory requirements. The role will also involve conducting Supplier and Contract Service Provider audits, monitoring changes to EU regulatory requirements, and hosting inspections.

Requirements

• Eligible to act as a Qualified Person under EU legislation (Directive 2001/83/EC)
• Pharmaceutical Quality System (PQS) Auditor certification is highly preferred
• Bachelor's degree in pharmacy, chemistry, biology or a related scientific field is required
• Strong understanding of EU and Rest-of-World (ROW) regulatory and compliance requirements
• Demonstrated experience in Supplier Compliance and Inspection Management
• Firm knowledge of GMPs, GDPs and Quality Management Systems
• Experience using Inspection Management Software
• Minimum 10 years of experience in Biopharmaceutical industry
• Minimum 7 Years of experience in Supplier Quality Management
• Minimum 3 Years of experience with Oral Solid Dosage forms
• Minimum 4 Years of experience in a Qualified Person role

Benefits

• Competitive compensation and benefits package
• Open, flexible, and friendly work environment
• Platform to develop long-term careers