✨ AI Insights & Summary
Olema Oncology is seeking a Senior Manager, GCP Clinical Quality to ensure compliance and drive process improvements in their groundbreaking breast cancer therapies. This hybrid role, based in San Francisco or Cambridge, offers a critical opportunity to oversee quality assurance for clinical trials, contributing directly to the development of potentially life-saving medicines. If you have extensive experience in pharmaceutical quality assurance, a deep understanding of GCP/GVP regulations, and a passion for making a profound impact in oncology, this position provides a chance to shape the future of cancer treatment within a dynamic and supportive biotech environment.
About Olema Oncology
Olema Oncology is dedicated to developing advanced medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist, and our follow-on candidate, OP-3136, is a KAT6 inhibitor. We foster a culture where scientific breakthroughs are accelerated through mutual support, motivation, and challenge.
About the Role
As the Senior Manager, GCP Clinical Quality, you will report to the Senior Director GCP Quality Assurance. You will partner with Clinical Development/Operations and Pharmacovigilance/Safety teams to ensure GCP/GVP compliance, identify clinical trial-related risks, and drive process improvements. This hybrid role requires 2 days a week on-site at our San Francisco, CA, or Cambridge, MA office, with up to 25% travel.
Your Work Will Primarily Encompass:
- Perform internal and external audits to ensure compliance with GCP/GVP regulations and guidelines.
- Provide GCP/GVP auditing activities, including preparation, execution, report preparation, and follow-up on findings/CAPAs.
- Support regulatory authority inspections and assist with GxP inspection readiness.
- Oversee quality aspects of clinical study start-up, execution, and close-out, providing leadership and guidance.
- Assist in preparation for health authority inspections, suppliers, and/or clinical sites.
- Oversee clinical compliance and quality within cross-functional study teams.
- Refine Olema’s risk-based GCP compliance approach globally.
- Support the Quality Management System (QMS), including QA review/approval of deviations, CAPAs, and change controls.
- Draft, review, and approve policies, procedures, and work instructions.
Ideal Candidate Profile: Key Requirements
Knowledge:
- Bachelor’s degree in a scientific discipline.
- Strong understanding of clinical trials and pharmacovigilance reporting.
- Strong understanding of FDA, EMA, and ICH Health compliance requirements.
- Understanding of industry quality management tools and systems (e.g., QMS, eTMF, EMRs, EDC).
Experience:
- Minimum of 8 years of relevant experience in Quality Assurance or a related role in a pharmaceutical, biotechnology, or related environment.
- Demonstrated experience leading and/or conducting internal and external QA audits and developing risk-based audit plans.
- Demonstrated ability to develop and foster positive, collaborative relationships with internal staff and external vendors.
- Experience supporting regulatory agency inspections.
- Experience writing and reviewing SOPs.
- Experience using QMS (Veeva systems preferred).
- Knowledge and experience in Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) regulations. GLP experience is preferred.
Attributes:
- Excellent verbal and written communication skills.
- Ability to work independently and collaboratively in a fast-paced, matrixed team environment.
- Analytical thinker with excellent problem-solving skills and adaptability.
- Excellent planning, organization, and time management skills.
Compensation & Benefits
- The base pay range for this position is expected to be $160,000 - $180,000 annually, depending on location, market, knowledge, skills, capabilities, and experience.
- Total compensation includes equity, bonus, and benefits.
- Olema provides equal opportunity and fosters a culture where differences are celebrated.
- We offer a competitive compensation and benefits package in an open, flexible, and friendly work environment.