Associate Director, GCP Quality Assurance
Olema Oncology, Cambridge, MA, United States
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 (CERAN) 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 >>> Associate Director, GCP Quality Assurance As the Associate Director, GCP Quality Assurance, reporting to the Senior Director GCP Quality Assurance, you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety in cross‑functional study teams to drive GCP/GVP compliance. This will include 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 either our
San Francisco, CA
or
Cambridge, MA
office and requires up to 20% 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), and communicate audit results to internal stakeholders
Partner with QA leadership during regulatory authority inspections and drive 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
Prepare 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
Manage Quality Management System (QMS) including, but not be limited to, 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 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.)
Experience:
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
Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines
Attributes:
Excellent verbal and written communication skills
Ability to work independently and collaboratively, as required, in a fast‑paced, matrixed, team environment consisting of internal and external team members
Analytical thinker with excellent problem‑solving skills and the ability to adapt to changing priorities and deadlines
Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects
Ability to work hands‑on and be a strong individual contributor
The base pay range for this position is expected to be
$190,000 - $210,000
annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position 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. Thank you.
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 olema.com; our careers page is lhes them; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. 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 of any kind, and does not make job offers without an in‑person interview.
#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 >>> Associate Director, GCP Quality Assurance As the Associate Director, GCP Quality Assurance, reporting to the Senior Director GCP Quality Assurance, you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety in cross‑functional study teams to drive GCP/GVP compliance. This will include 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 either our
San Francisco, CA
or
Cambridge, MA
office and requires up to 20% 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), and communicate audit results to internal stakeholders
Partner with QA leadership during regulatory authority inspections and drive 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
Prepare 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
Manage Quality Management System (QMS) including, but not be limited to, 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 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.)
Experience:
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
Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines
Attributes:
Excellent verbal and written communication skills
Ability to work independently and collaboratively, as required, in a fast‑paced, matrixed, team environment consisting of internal and external team members
Analytical thinker with excellent problem‑solving skills and the ability to adapt to changing priorities and deadlines
Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects
Ability to work hands‑on and be a strong individual contributor
The base pay range for this position is expected to be
$190,000 - $210,000
annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position 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. Thank you.
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 olema.com; our careers page is lhes them; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. 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 of any kind, and does not make job offers without an in‑person interview.
#J-18808-Ljbffr