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Manager Quality Assurance I-O Development Quality

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Waltham, MA

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Manager Quality Assurance, I-O Development Quality

Do you have the passion to join a young global biopharmaceutical whose sole mission is to improve the lives of patients bravely facing cancer? Does it excite you to be a part of a rapidly expanding company with multiple marketed products and a diverse and robust pipeline? If yes, you may be a great fit for our community of dedicated and innovative associates.

Your Impact at TESARO:

Responsible for the Quality oversight of assigned projects in the immuno-oncology clinical trial manufacture. Review and approval of deviations and CAPAs, as well as approve and monitor the status of GMP environments. Batch record review and release, assist in conducting quality audits of contracted production and managing the vendor qualification program.

Job Responsibilities:

• Maintaining time-lines for the release of Immuno-oncology (IO) product
• Review master and executed batch records and associated documentation
• Perform activities associated with lot disposition
• Assist in the qualification of new facilities for drug substance and drug product manufacturing
• Review and approve stability data
• Review of data associated with certificate of analysis generation
• Oversee any investigations and ensure the execution and closure of CAPA plans.
• Provides oversight of compliance of third parties to GMPs and established quality agreements.
• Review and identify trends in environmental monitoring data.


• Bachelor’s Degree in the natural or biological science or related experience
• 5-7 years of Quality Assurance experience in the biopharmaceutical industry
• 2-4 years of Pharmaceutical Auditing experience or Certified Quality Auditor
• Preferred Biologics Quality Assurance experience
• Ability to travel, including international is required.

TESARO is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

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