Olema Oncology
Senior Manager, GCP Quality
Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP‑1250), is a complete estrogen‑receptor antagonist currently in development for metastatic breast cancer. We also develop OP‑3136, a potent KAT6 inhibitor.
About the Role As the Senior Manager, GCP Clinical Quality reporting to the Director, GCP Quality, you will partner with Clinical Development/Operations, Pharmacovigilance and Safety to participate in cross‑functional study teams. Your primary focus will be ensuring GCP/GVP compliance, identifying and communicating clinical‑trial‑related risks, improving processes, reviewing and approving study documents, and supporting audits.
Location: Hybrid – office in San Francisco, CA or Cambridge, MA. Requires 2 days per week onsite and up to 25% travel.
Responsibilities
Perform internal and external audits to ensure compliance with GCP/GVP regulations and guidelines.
Lead GCP/GVP audit activities, including preparation, execution, report preparation, follow‑up actions, and corrective/preventive actions (CAPAs). Communicate audit results to stakeholders.
Support regulatory authority inspections and GxP inspection readiness activities.
Oversee quality aspects of clinical study start‑up, execution, and close‑out, providing leadership and direction to staff.
Assist in preparation for health authority inspections, suppliers, and/or clinical sites.
Maintain clinical compliance and quality within cross‑functional study teams.
Continuously improve Olema’s global risk‑based GCP compliance approach.
Support the Quality Management System (QMS): review/approve deviations, CAPAs, and change controls.
Draft, review, and approve policies, procedures, and work instructions.
Ideal Candidate Profile 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.
Familiarity with industry quality‑management tools and systems (QMS, eTMF, EMR, EDC, etc.).
Experience
8+ years in Quality Assurance or related roles within pharmaceuticals, biotechnology, or related environments.
Experience leading and conducting internal and external QA audits, developing and executing risk‑based audit plans.
Demonstrated ability to foster collaborative relationships with internal staff and external vendors.
Experience supporting regulatory agency inspections.
Experience writing and reviewing SOPs.
Experience using QMS systems (Veeva preferred).
Knowledge and experience of GCP, GVP regulations; GLP experience preferred.
Attributes
Excellent verbal and written communication skills.
Ability to work independently and collaboratively in a fast‑paced, matrixed team environment.
Analytical thinker with strong problem‑solving skills and adaptability.
Excellent planning, organization, and time‑management skills.
Hands‑on work style with the ability to be a strong individual contributor.
Compensation Base pay range: $160,000 – $185,000 annually (salary may vary by location, market, and experience). Total compensation includes equity, bonus, and benefits.
Equal Opportunity We provide equal opportunity to all employees and applicants for employment.
Benefits We offer a competitive compensation and benefits package. A summary of benefits is available for all applicants.
Important Information Please note: Olema does not accept agency resumes and is not responsible for any fees related to unsolicited resumes.
Fraud Alert Olema’s official email addresses end in
@olema.com . Official sites:
olema.com
and careers page
olema.com/careers .
Apply To apply, sign in or create an account to submit your application.
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About the Role As the Senior Manager, GCP Clinical Quality reporting to the Director, GCP Quality, you will partner with Clinical Development/Operations, Pharmacovigilance and Safety to participate in cross‑functional study teams. Your primary focus will be ensuring GCP/GVP compliance, identifying and communicating clinical‑trial‑related risks, improving processes, reviewing and approving study documents, and supporting audits.
Location: Hybrid – office in San Francisco, CA or Cambridge, MA. Requires 2 days per week onsite and up to 25% travel.
Responsibilities
Perform internal and external audits to ensure compliance with GCP/GVP regulations and guidelines.
Lead GCP/GVP audit activities, including preparation, execution, report preparation, follow‑up actions, and corrective/preventive actions (CAPAs). Communicate audit results to stakeholders.
Support regulatory authority inspections and GxP inspection readiness activities.
Oversee quality aspects of clinical study start‑up, execution, and close‑out, providing leadership and direction to staff.
Assist in preparation for health authority inspections, suppliers, and/or clinical sites.
Maintain clinical compliance and quality within cross‑functional study teams.
Continuously improve Olema’s global risk‑based GCP compliance approach.
Support the Quality Management System (QMS): review/approve deviations, CAPAs, and change controls.
Draft, review, and approve policies, procedures, and work instructions.
Ideal Candidate Profile 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.
Familiarity with industry quality‑management tools and systems (QMS, eTMF, EMR, EDC, etc.).
Experience
8+ years in Quality Assurance or related roles within pharmaceuticals, biotechnology, or related environments.
Experience leading and conducting internal and external QA audits, developing and executing risk‑based audit plans.
Demonstrated ability to foster collaborative relationships with internal staff and external vendors.
Experience supporting regulatory agency inspections.
Experience writing and reviewing SOPs.
Experience using QMS systems (Veeva preferred).
Knowledge and experience of GCP, GVP regulations; GLP experience preferred.
Attributes
Excellent verbal and written communication skills.
Ability to work independently and collaboratively in a fast‑paced, matrixed team environment.
Analytical thinker with strong problem‑solving skills and adaptability.
Excellent planning, organization, and time‑management skills.
Hands‑on work style with the ability to be a strong individual contributor.
Compensation Base pay range: $160,000 – $185,000 annually (salary may vary by location, market, and experience). Total compensation includes equity, bonus, and benefits.
Equal Opportunity We provide equal opportunity to all employees and applicants for employment.
Benefits We offer a competitive compensation and benefits package. A summary of benefits is available for all applicants.
Important Information Please note: Olema does not accept agency resumes and is not responsible for any fees related to unsolicited resumes.
Fraud Alert Olema’s official email addresses end in
@olema.com . Official sites:
olema.com
and careers page
olema.com/careers .
Apply To apply, sign in or create an account to submit your application.
#J-18808-Ljbffr