Olema Oncology
About Olema Oncology
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 with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow‑on product candidate, OP-3136, is a potent KAT6 inhibitor with best‑in‑class potential.
Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for
our patients, for your career, for what’s beyond
.
About the Role Senior Manager, GCP Clinical Quality reporting to the Director GCP Quality will partner with Clinical Development/Operations, Pharmacovigilance and Safety to participate in cross‑functional study teams, ensuring GCP/GVP compliance, identifying and communicating clinical trial‑related risks and opportunities for process improvement, reviewing and 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 two days a week on site and up to 25% travel.
Responsibilities
Perform internal and external audits to ensure compliance with GCP/GVP regulations and guidelines.
Conduct GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow‑up to findings/observations, including CAPAs; communicate audit results to internal stakeholders.
Support 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.
Assist in preparation for health authority inspections, suppliers and/or clinical sites.
Oversee clinical compliance and quality in the context of cross‑functional study teams.
Continue to improve/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, quality systems (QMS, eTMF, EMRs, EDC, etc.).
Experience
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 and developing risk‑based audit plans.
Demonstrated ability to develop and foster positive, collaborative relationships with internal staff and external third‑party vendors.
Experience supporting regulatory agency inspections.
Experience writing and reviewing SOPs.
Experience using QMS (Veeva systems preferred).
Knowledge and experience in GCP, GVP regulations; preferred GLP experience.
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 ability to adapt to changing priorities and deadlines.
Excellent planning, organization, and time‑management skills, including ability to support and prioritize multiple projects.
Compensation The base pay range is $160,000 – $185,000 annually. Total compensation also includes equity, bonus, and benefits.
Important Information We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long‑term careers. A summary of benefits is available for all applicants.
Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes.
Fraud Alert We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olem.com; our careers page is olem.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments, and does not make job offers without an in‑person interview.
Job Details Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Research, Science, and Manufacturing
Industries: Biotechnology Research and Pharmaceutical Manufacturing
Location: San Francisco, CA OR Cambridge, MA
#J-18808-Ljbffr
Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for
our patients, for your career, for what’s beyond
.
About the Role Senior Manager, GCP Clinical Quality reporting to the Director GCP Quality will partner with Clinical Development/Operations, Pharmacovigilance and Safety to participate in cross‑functional study teams, ensuring GCP/GVP compliance, identifying and communicating clinical trial‑related risks and opportunities for process improvement, reviewing and 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 two days a week on site and up to 25% travel.
Responsibilities
Perform internal and external audits to ensure compliance with GCP/GVP regulations and guidelines.
Conduct GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow‑up to findings/observations, including CAPAs; communicate audit results to internal stakeholders.
Support 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.
Assist in preparation for health authority inspections, suppliers and/or clinical sites.
Oversee clinical compliance and quality in the context of cross‑functional study teams.
Continue to improve/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, quality systems (QMS, eTMF, EMRs, EDC, etc.).
Experience
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 and developing risk‑based audit plans.
Demonstrated ability to develop and foster positive, collaborative relationships with internal staff and external third‑party vendors.
Experience supporting regulatory agency inspections.
Experience writing and reviewing SOPs.
Experience using QMS (Veeva systems preferred).
Knowledge and experience in GCP, GVP regulations; preferred GLP experience.
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 ability to adapt to changing priorities and deadlines.
Excellent planning, organization, and time‑management skills, including ability to support and prioritize multiple projects.
Compensation The base pay range is $160,000 – $185,000 annually. Total compensation also includes equity, bonus, and benefits.
Important Information We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long‑term careers. A summary of benefits is available for all applicants.
Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes.
Fraud Alert We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olem.com; our careers page is olem.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments, and does not make job offers without an in‑person interview.
Job Details Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Research, Science, and Manufacturing
Industries: Biotechnology Research and Pharmaceutical Manufacturing
Location: San Francisco, CA OR Cambridge, MA
#J-18808-Ljbffr