Position Summary

Tesaro is a growing oncology-focused biopharmaceutical company whose passionate associates are dedicated to improving the lives of cancer patients by developing and providing safer and more effective therapeutics and supportive care products. The Manager, Quality Assurance will be responsible for the Quality oversight of assigned projects in production of clinical materials (API and drug product) and the various activities in the conduct of clinical trials.   Reporting to the Director, Quality Assurance, the Manager will review and approve non-conformance and CAPA issues, as well as approve and monitor the validated status of GMP and GCP environments.  Responsibilities include conducting quality audits of contracted production and clinical services and managing the vendor qualification program.  The Manager will also perform training on the company Quality System, as needed and will write and review company standard operating procedures and may participate in the auditing of regulatory dossiers.

Responsibilities

• Assist in batch release through batch record and data review/approval and managing process deviations for timely release
• Develop in-process and release specifications
• Operate the systems for deviations, CAPAs, change control in an efficient manner for adequate and timely closeout of these events
• Maintain the vendor qualification program through timely audits and follow-up actions
• Schedule, perform and manage GxP audits
• Evaluate, approve and track manufacturing deviations, CAPAs and change control
• Write SOPs to further develop the Quality System and control over the quality of vendor services and products
• Assist in the building and management of the documentation system
• Assist in the development of Quality metrics
• Train appropriate personnel on quality procedures
• Assist in the QC review of various documents, including regulatory dossiers and reports
• Assist in the planning of budgets
• As appropriate, attend project meetings and provide development quality input and lead the resolution of quality-related issues
• Clearly communicate issues to vendors and Tesaro management in a timely basis
• Regularly meet with the Director of QA to update activities, resolve issues, maintain time lines and plan in order to meet the company’s goals

Education/Experience

• Bachelor’s degree in a scientific area.
• 8+ years’ experience in the pharmaceutical/bio-pharm manufacturing industry with at least 3 of those years at the QA manager level.
• Experience building relationships and working with in-house drug manufacturing and CMOs and auditing vendors
• Working knowledge ICH quality guidance, EU and FDA drug manufacturing regulations
• Relevant ASQ certifications (auditing or quality management) are a plus.
• GCP experience is a plus
• Competency in MS Office Products and Adobe Acrobat
• Able to work a flexible work schedule to accommodate program priorities and international activities as needed
• Ability to travel (includes international), 10%