Olema Oncology · 2 weeks ago
Director, GMP and Quality Systems Compliance
San Francisco, CA
Full-time
Hybrid
Director/Executive
$225K/yr - $240K/yr
15+ years expOlema Oncology is dedicated to developing better medicines for breast cancer and beyond. As the Director, GMP and Quality Systems Compliance, you will lead and oversee compliance across Olema’s GMP and Quality Systems functions, establishing procedural requirements and maintaining inspection readiness while collaborating with various business functions to ensure quality oversight.
BiopharmaBiotechnologyHealth CareMedicalOncologyPharmaceutical
Responsibilities
Lead and oversee compliance across Olema’s GMP and Quality Systems functions
Establish the procedural and system requirements for Supplier and Contract Service Provider (CSP) 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
Coordinate the execution of annual Quality System reviews, including Quality Management Review (QMR) and Annual Product Reviews following commercial launch
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
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
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
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
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
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)
Qualification
Required
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
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
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
Preferred
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
Benefits
Equity
Bonus
Benefits
Competitive compensation and benefits package
Company
Olema Oncology
Olema Oncology is a preclinical biotechnology company that develops new drugs for the treatment and prevention of breast cancer.
51-200 employees
H1B Sponsorship
Olema Oncology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (3)
2022 (2)
Funding
Current Stage
Public CompanyTotal Funding
$765.05MKey Investors
Paradigm BioCapital AdvisorsSilicon Valley BankVivo Capital
2025-11-20Post Ipo Equity· $190M
2024-12-02Post Ipo Equity· $250M
2023-09-05Post Ipo Equity· $130M
Leadership Team
Naseem Zojwalla
Chief Medical Officer
Shane Kovacs
Chief Operating and Financial Officer
Recent News
2025-12-25
thefly.com
2025-12-11
Company data provided by crunchbase