Posted in Other 30+ days ago.
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Type: Full Time
Location: Waltham, Massachusetts
SENIOR MANAGER QUALITY CONTROL - I/O PROGRAMS
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:
The Senior Manager, Quality Control is responsible for the day-to-day oversight of analytical testing at contract laboratories and contract manufacturing facilities for testing of development pharmaceutical products and Active Pharmaceutical Ingredients (API) in support of TESAROs immuno-oncology programs. The individual will interact with internal multidisciplinary teams to ensure successful delivery schedules of analytical test reports or certificates. This includes assisting with QC checks and preparation of regulatory filings (INDs and NDAs), and managing projects associated with drug substance and products.
* Manage drug substance and drug product analytical testing at contract laboratories.
* Execute and manage stability activities including maintenance of master stability protocols and individual study plans, set-up of stability studies, data review and trend evaluation and report writing
* Investigate and resolve analytical test failures (OOS and atypical results).
* Monitor contract laboratory activities to ensure compliance and timeliness of certificates of approval and reports.
* Summarize and report laboratory performance metrics.
* Review QC raw data and assist in batch release.
* Assemble data packages in support of specification and method changes associated with TESARO products.
* Assist in the preparation of the analytical sections of regulatory filings (Supplements, and Annual Reports).
* Review and approve various quality documents associated with TESARO products.
* Provide analytical support for manufacturing investigations as required.
* Participate in vendor and internal audits, as needed.
* Maintain current knowledge of all relevant USP/NF and EP requirements and FDA/EU guidances.
* BS in a scientific discipline with 8 years biotech/pharmaceutical industry experience, including at least 3 years at the QC manager level. Experience with biologic products a plus.
* Knowledge of analytical testing concepts and current cGMPs including laboratory controls and good documentation practices.
* Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts.
* Experience building relationships and working with CMOs
* Working knowledge of ICH quality guidance, EU and FDA drug manufacturing regulations
* Ability to work a flexible work schedule to accommodate program priorities and international activities as needed
* Ability to travel (includes international) approximately 10%.
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.