Senior Manager, GCP Quality Assurance

Olema Oncology is  a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with  breast cancer  and beyond.   It’s  an exciting time to be part of Team Olema ,  with   our transfor mation into a fully   integrated oncology company well underway ,  t op-line data from our lead program expected  later  this  year ,   and our first potential commercial launch on the horizon. Our lead product candidate, palazestrant, is a novel, orally available complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) currently in two pivotal Phase 3 clinical trials. We expect top-line data from OPERA-01, our ongoing Phase 3 trial of palazestrant as a monotherapy in patients with second- or third-line ER+/HER2- metastatic breast cancer (MBC), in the fall which, if successful, could lead to our first potential approval and commercial launch in 2027. OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients. Together with its mechanism of action, pharmacokinetic properties, and the potential to demonstrate activity in both ESR1 wild-type and mutant tumors, palazestrant has the potential to transform the metastatic breast cancer treatment paradigm and access a $15 billion global market opportunity. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to generate further value and meaningfully impact the metastatic breast cancer treatment landscape – particularly in combination with palazestrant. We recently reported encouraging Phase 1 monotherapy data from this program across multiple solid tumor types and are advancing patient enrollment in the ongoing combination arms in MBC. Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and a passionate team dedicated to helping the patients we serve feel better, longer. We possess a deep commitment to our shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution.  Team Olema is made up of nimble self-starters who bring consistency in their quest for the extraordinary every single day. If you’re ready to be part of a tenacious, courageous, agile, and growing team, join us in making a profound impact, together –  for  our patients, for your career,  and  for  what’s  beyond . About the Role  >>> Senior Manager, GCP Clinical Quality As the Senior Manager, GCP Clinical Quality reporting to the Senior Director GCP Quality Assurance, you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety to actively participate in cross-functional study teams to ensure GCP/GVP compliance, assisting in identifying and communicating clinical trial-related risks and opportunities for process improvement as well as reviewing / approving study-related documents and plans and supporting audits. This hybrid role is based out of our San Francisco, CA or Cambridge, MA office requires 2 days a week on site and up to 25% travel. Your work will primarily encompass: Perform internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders Provide a support role during regulatory authority inspections and assist with GxP inspection readiness activities Oversee quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP Assist in preparation for health authority inspections, suppliers and/or clinical sites Oversee clinical compliance and quality within the context of cross-functional study teams Continue to improve/refine Olema’s risk based GCP compliance approach globally Support Quality Management System (QMS) including, but not be limited to, the following activities: QA review/approval of deviations, CAPAs and change controls Draft, review, and approve policies, procedures and work instructions Ideal Candidate Profile >>> Key Requirements A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge , experience , and attributes for this role. Knowledge: Bachelor’s degree in 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, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.). Experience: 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 Experience supporting regulatory agency inspections 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) e