Senior Manager, Quality Assurance
Senior Manager, Quality Assurance
There is nothing conditional about what we do.
Or who we are.
Or how we treat you.
We do what’s right.
We put science for patients first,
disrupting the model to go beyond
the concepts of conventional care.
We don’t treat a condition.
We treat people & partners.
We care to change the future.
Your Impact at TESARO:
Responsible for the Quality oversight of assigned projects in production of the regulatory starting material(s), API and drug product, and the various activities in the disposition of commercial product. Review and approve non-conformance and CAPA issues, as well as approve and monitor the validated status of the GMP environment. Responsibilities include conducting quality audits of contracted production services and managing the vendor qualification and periodic audit program. Perform training on the company quality systems, as needed and will write and review company SOPs, and may participate in the auditing of regulatory dossiers.
- Review and approve master batch records, master labeling/packaging records, product specifications, stability protocols, stability reports, and other process related documents from contract sites.
- Perform batch disposition through batch record and data review/approval and managing process deviations for timely release
- Review and/or approve deviations, OOSs, 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
- Write, revise and periodically review SOPs to further develop the Quality System and control over the quality of vendor services and products
- Review and approve manufacturing validation protocols and reports..
- Assist in the development and tracking of Quality metrics. Prepare metrics for the Management Review and Annual Product Review.
- Assist in the QC review of various documents, including regulatory dossiers and reports
- As appropriate, attend project meetings and provide development quality input and lead the resolution of quality-related issues
- Supports the preparation, coordination, and management of regulatory agency Preapproval or regular inspections.
- Provides Quality Assurance leadership, guidance, and direction to CMOs consistent with cGMPs and TESARO quality compliance.
- Bachelor’s degree in a scientific area or combination of education and work experience.
- 8+ years’ experience in the pharmaceutical/bio-pharm manufacturing industry with at least 3 of those years at the QA manager level.
- Experience and working knowledge about the small molecules chemistry, tablets and capsules as well as sterile formulation
- 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
- Ability to travel (includes international), 20%
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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