Your Impact at TESARO:
Responsible for the Quality oversight of assigned projects in production of drug product, primary and secondary packaged 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. The Sr. 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.
• Review and approve master batch records, master labeling/packaging records, product specifications, validation protocols/reports and other process related documents from contract sites. • Perform batch release 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 • Schedule, perform and manage GMP audits • Write, revise and periodically review SOPs to further develop the Quality System and control over the quality of vendor services and products • Attend project meetings and provide commercial quality input and lead the resolution of commercial quality-related issues • Support regulatory inspections at commercial contract sites. • Provides commercial quality assurance leadership, guidance, and direction to CMOs consistent with cGMPs and TESARO quality compliance.
• Bachelor’s degree in a scientific area. • 6-8 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 with small molecules (tablets, sterile injectable), primary and secondary packaging; sterile formulation a plus. • Experience building relationships and working with CMOs as well as auditing vendors. • Working knowledge ICH quality guidance, EU and FDA drug manufacturing regulations. • Relevant ASQ certifications (auditing or quality management) are a plus. • QC 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), 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.