Olema Oncology
Director, GMP and Quality Systems Compliance
Olema Oncology, Cambridge, Massachusetts, us, 02140
Director, GMP and Quality Systems Compliance
Join to apply for the Director, GMP and Quality Systems Compliance role at 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 (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.
As the Director, GMP and Quality Systems Compliance, reporting to the Senior Director, Quality Assurance, you will lead and oversee compliance across Olema’s GMP and Quality Systems functions. You will establish procedural and system requirements for Supplier and Contract Service Provider Quality Management, maintain continuous inspection readiness across Olema’s clinical—and future commercial—network, develop and maintain a Regulatory Intelligence function, oversee internal audits and self‑assessments, and coordinate the execution of annual Quality System reviews, including Quality Management Review (QMR) and Annual Product Reviews following commercial launch. This role is based in either Cambridge, MA or San Francisco, CA and requires up to 25% travel, including some international.
Supplier / Contract Service Provider Quality Management
Partner with regulated business functions to identify Suppliers and CSPs requiring quality and compliance oversight
Establish appropriate assessment mechanisms, risk‑based controls, and monitoring and feedback loops to ensure compliant, effective oversight
Serve as a resource for the conduct of audits and other assessments, both internally and externally
Inspection Readiness and Compliance Infrastructure
Establish and maintain the infrastructure and processes required to prepare Olema and its business partners for inspections by U.S. and international regulatory authorities
Utilize electronic systems, including Artificial Intelligence‑enabled tools, to support inspection readiness activities
Deploy and maintain Inspection Management Software to ensure consistent and reliable inspection preparation and response
Regulatory Intelligence and Monitoring
Create and maintain a Regulatory Intelligence function focused on understanding inspectorate enforcement trends and providing insights that support accelerated product development
Monitor inspectional status and compliance trends within the Olema Supplier and CSP network
Apply Generative AI tools, where appropriate, to support the monitoring and interpretation of regulatory trends and inspection outcomes
Internal Compliance Risk Identification and Quality Improvement
Develop strategic, minimally disruptive methods to identify internal compliance risks and opportunities related to quality, efficiency, and effectiveness
Collaborate with internal partners to build commitment and alignment around the implementation of identified opportunities for improvement
Provide guidance and direction to ensure Quality and regulated functions meet annual Quality System commitments in a timely manner as Olema advances toward commercial operations
Annual Reviews and Quality System Leadership
Lead and coordinate the annual Quality Management Review process
Oversee the preparation and execution of Annual Product Quality Reviews upon commercial product launch
Collaborate with Quality Systems to plan and deliver annual GxP topical training for relevant functions
Additional Responsibilities
Deploy Inspection Management Software and ensure users receive appropriate training
Use and train others in the application of Artificial Intelligence toolsets for Quality and Compliance operations
Advise cross‑functional partners on the risk‑appropriate and timely deployment of additional Quality and GMP technologies
Perform audits and execute Supplier or CSP questionnaires
Process Supplier Corrective Action Requests (SCARs) and External Change Notifications (ECNs)
Ideal Candidate Profile Knowledge
Bachelor’s degree in biology or a related scientific field is required
Strong understanding of U.S., EU, California, and Rest‑of‑World (ROW) regulatory and compliance requirements
Demonstrated experience in Supplier Compliance and Inspection Management
Firm knowledge of GMPs and Quality Management Systems
Experience using Inspection Management Software
Experience
Minimum 15 years of experience in Biopharmaceutical industry
Minimum 10 years of experience in Supplier Quality Management
Experience with Oral Solid Dosage forms is required
Pharmaceutical Auditor certification is highly preferred
Oncology experience is preferred
People management or leadership experience is desirable, particularly given the need to oversee contract resources and support future functional growth
Attributes
Self‑directed and capable of independently setting and managing priorities
Able to adapt to a rapidly changing organization characterized by historical ambiguity and evolving process definition
Applies a risk‑based approach to quality and compliance, with strong appreciation for both business needs and patient impact
Demonstrates strong cross‑functional partnership, collaboration, and communication skills
Comfortable adopting new technologies and tailoring them to Olema’s Quality and Compliance needs
Team‑oriented, focused on collective success and delivering meaningful impact
Passionate about meaningful work and contributing to patient‑focused outcomes
Base pay range for this position is expected to be $225,000 - $240,000 annually. Total compensation 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.
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
olema.com/careers ; 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
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.
As the Director, GMP and Quality Systems Compliance, reporting to the Senior Director, Quality Assurance, you will lead and oversee compliance across Olema’s GMP and Quality Systems functions. You will establish procedural and system requirements for Supplier and Contract Service Provider Quality Management, maintain continuous inspection readiness across Olema’s clinical—and future commercial—network, develop and maintain a Regulatory Intelligence function, oversee internal audits and self‑assessments, and coordinate the execution of annual Quality System reviews, including Quality Management Review (QMR) and Annual Product Reviews following commercial launch. This role is based in either Cambridge, MA or San Francisco, CA and requires up to 25% travel, including some international.
Supplier / Contract Service Provider Quality Management
Partner with regulated business functions to identify Suppliers and CSPs requiring quality and compliance oversight
Establish appropriate assessment mechanisms, risk‑based controls, and monitoring and feedback loops to ensure compliant, effective oversight
Serve as a resource for the conduct of audits and other assessments, both internally and externally
Inspection Readiness and Compliance Infrastructure
Establish and maintain the infrastructure and processes required to prepare Olema and its business partners for inspections by U.S. and international regulatory authorities
Utilize electronic systems, including Artificial Intelligence‑enabled tools, to support inspection readiness activities
Deploy and maintain Inspection Management Software to ensure consistent and reliable inspection preparation and response
Regulatory Intelligence and Monitoring
Create and maintain a Regulatory Intelligence function focused on understanding inspectorate enforcement trends and providing insights that support accelerated product development
Monitor inspectional status and compliance trends within the Olema Supplier and CSP network
Apply Generative AI tools, where appropriate, to support the monitoring and interpretation of regulatory trends and inspection outcomes
Internal Compliance Risk Identification and Quality Improvement
Develop strategic, minimally disruptive methods to identify internal compliance risks and opportunities related to quality, efficiency, and effectiveness
Collaborate with internal partners to build commitment and alignment around the implementation of identified opportunities for improvement
Provide guidance and direction to ensure Quality and regulated functions meet annual Quality System commitments in a timely manner as Olema advances toward commercial operations
Annual Reviews and Quality System Leadership
Lead and coordinate the annual Quality Management Review process
Oversee the preparation and execution of Annual Product Quality Reviews upon commercial product launch
Collaborate with Quality Systems to plan and deliver annual GxP topical training for relevant functions
Additional Responsibilities
Deploy Inspection Management Software and ensure users receive appropriate training
Use and train others in the application of Artificial Intelligence toolsets for Quality and Compliance operations
Advise cross‑functional partners on the risk‑appropriate and timely deployment of additional Quality and GMP technologies
Perform audits and execute Supplier or CSP questionnaires
Process Supplier Corrective Action Requests (SCARs) and External Change Notifications (ECNs)
Ideal Candidate Profile Knowledge
Bachelor’s degree in biology or a related scientific field is required
Strong understanding of U.S., EU, California, and Rest‑of‑World (ROW) regulatory and compliance requirements
Demonstrated experience in Supplier Compliance and Inspection Management
Firm knowledge of GMPs and Quality Management Systems
Experience using Inspection Management Software
Experience
Minimum 15 years of experience in Biopharmaceutical industry
Minimum 10 years of experience in Supplier Quality Management
Experience with Oral Solid Dosage forms is required
Pharmaceutical Auditor certification is highly preferred
Oncology experience is preferred
People management or leadership experience is desirable, particularly given the need to oversee contract resources and support future functional growth
Attributes
Self‑directed and capable of independently setting and managing priorities
Able to adapt to a rapidly changing organization characterized by historical ambiguity and evolving process definition
Applies a risk‑based approach to quality and compliance, with strong appreciation for both business needs and patient impact
Demonstrates strong cross‑functional partnership, collaboration, and communication skills
Comfortable adopting new technologies and tailoring them to Olema’s Quality and Compliance needs
Team‑oriented, focused on collective success and delivering meaningful impact
Passionate about meaningful work and contributing to patient‑focused outcomes
Base pay range for this position is expected to be $225,000 - $240,000 annually. Total compensation 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.
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
olema.com/careers ; 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