Olema Oncology · 20 hours ago
Senior Manager, GCP Quality Assurance
Cambridge, MA
Full-time
Hybrid
Senior Level
$175K/yr - $190K/yr
7+ years expOlema Oncology is dedicated to developing better medicines for breast cancer and beyond. As the Sr. Manager GCP Clinical Quality, you will partner with Clinical Development/Operations, Pharmacovigilance, and Safety to ensure GCP/GVP compliance and support audits while identifying risks and opportunities for process improvement.
BiopharmaBiotechnologyHealth CareMedicalOncologyPharmaceutical
Hiring Manager
Colleen Kabongo SHRM-CP
Responsibilities
Assist in preparation for, and support of health authority inspections
Supporting the training of cross-functional teams on inspection expectations and processes
Verifying the completeness, accuracy, and availability of inspection-ready documentation
Contributing to the development of inspection storyboards and key messaging
Facilitating and participating in mock inspection activities
Serving in front-room and back-room roles as required during inspections
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), communicate audit results to internal stakeholders
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
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
Support 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
Qualification
Required
Bachelor's degree is required
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 (e.g., QMS, eTMF, EMRs, EDC, etc.)
Minimum 7 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
Experience preparing for and supporting regulatory agency inspections, primarily FDA; additional experience with other global regulatory agencies is an advantage
Experience writing and reviewing SOPs
Knowledge and experience in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) regulations
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
Preferred
Advanced degree (MS, PharmD, PhD)
Experience using QMS (Veeva systems preferred)
Preferred Good Laboratory Practice (GLP) experience
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
2026-01-13
2025-12-25
Company data provided by crunchbase