Associate Director, GCP Quality Assurance

Olema Oncology is a biotechnology company dedicated to developing better medicines for breast cancer and beyond. The Associate Director, GCP Quality Assurance, will partner with Clinical Development/Operations, Pharmacovigilance and Safety to drive GCP/GVP compliance. This hybrid role requires up to 20% travel and involves performing internal and external audits, reviewing and approving study-related documents, and managing quality aspects related to clinical study start-up, execution, and close-out.

Requirements

• Bachelor’s Degree or higher in a scientific discipline
• Strong understanding of clinical trials and pharmacovigilance reporting
• In-depth knowledge of and ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines
• Understanding of industry quality management tools, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.)
• A minimum of 8 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment
• Demonstrated experience leading and/or conducting internal and external QA audits developing and executing risk-based audit plans
• Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors
• Hands-on experience with regulatory inspections and inspection readiness activities
• Experience writing and reviewing SOPs
• Experience using QMS (Veeva systems preferred)
• Knowledge and experience in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) regulations. In addition, preferred Good Laboratory Practice (GLP) experience

Benefits

• Competitive compensation and benefits package
• Flexible work environment
• Open and friendly work environment