Olema Oncology
Senior Manager, GCP Quality Assurance
San Francisco, California · Senior
Sponsorship not specified$160k-$180kDetected 21 days ago
GCPAuditingProcess ImprovementClinical TrialsFDA RegulatoryPharmacovigilanceLeadershipCommunicationProblem SolvingTime ManagementAdaptabilityGxP
About the role
- Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond.
- OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients.
- Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to generate further value and meaningfully impact the metastatic breast cancer treatment landscape - particularly in combination with palazestrant.
Responsibilities
- Perform internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines
- Provide a support role during regulatory authority inspections and assist with GxP inspection readiness activities
- Support Quality Management
- Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects
Requirements
- Bachelor's degree in scientific discipline
- Strong understanding of clinical trials and pharmacovigilance reporting
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
Nice to have
- Minimum of 8 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment
- Experience supporting regulatory agency inspections
- 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
Compensation
- The base pay range for this position is expected to be $ 160,000 - $180,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience.
Benefits
- Assist in preparation for health authority inspections, suppliers and/or clinical sites
- Strong understanding of FDA, EMA, and ICH Health compliance requirements
Company info
- 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
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