Senior Director, Quality Assurance

July 31

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Olema Oncology

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pharmaceuticals • biotechnology • drug development • oncology • breast cancer

51 - 200

Description

• Lead all quality activities supporting Olema's pipeline • Oversee the development, implementation and maintenance of quality assurance systems and activities • Manage business relationships with defined stakeholder groups • Strategic development and delivery of risk-based quality management and vendor quality oversight • Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions • Oversee all audits and proactively prepare the organization for inspection readiness • Lead and manage all regulatory inspections • Ensure compliance and constant state of inspection readiness across all GxP functions • Implement and maintain quality metrics, systems and documentation associated with developmental activities • Prepare the QA function to support registrational trials and commercial activities • Collaborate with R&D, product, manufacturing, clinical and regulatory teams

Requirements

• Bachelor's degree is required, preferably in a scientific field; advanced degree is a plus • High level of familiarity with a broad range of compliance areas and ability to assess risk and develop solutions • Advanced knowledge of Quality Assurance principles, concepts, industry practices and standards • Strong knowledge of US, EU and other regulatory compliance/GxP requirements • Deep understanding of small molecule and oncology drug product development • 15+ years of drug development, including 10+ years of quality assurance experience in the Biotech/Pharmaceutical industry • Strong proven hands-on experiences with GLP, GCP, GPV and GMP compliance matters, and contractor management in the bio/pharma industry • Extensive experience handling regulatory inspections required • Previous experience with building and implementing QA systems (QMS, RIM, LMS, etc.) • Experience supporting products from early-stage development to post-approval • Experience leading BIMO and PAI inspections • Experience leading and developing team of individual contributors • Strong business acumen and ability to successfully work with international and cross functional partners • Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism • Excellent verbal, written and communication skills • Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders • Fosters open communication. Listens and facilitates discussion • Flexible, able to be successful in a past paced, lightly structured environment

Benefits

• Competitive compensation and benefits package • Open, flexible, and friendly work environment • Summary of benefits available for applicants