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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP)

Location: United States

Proclinical is currently recruiting for a Quality Control Manager with a biopharmaceutical company located in Waltham, MA. The Quality Control Manager 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 drug substances in support of small molecule and/or 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 (IND, BLA and NDA), and manage projects associated with drug substance and products.

Job Responsibilities:

Assist in the management of drug substance and drug product analytical testing at contract laboratories
Assist in the management of stability activities including data review and trend evaluation
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
Review QC raw data and assist in batch release
Assemble data packages in support of specification and method changes associated with TESARO products
Represent QC in cross-functional teams with internal and external customers
Assist in the preparation of the analytical sections of regulatory filings (Supplements, and Annual Reports)
Review and approve various quality documents (internal and external) associated with TESARO products
Provide analytical support for manufacturing investigations as required
Participate in vendor and internal audits as needed
Contribute to company quality systems
Maintain current knowledge of all relevant USP/NF and EP requirements and FDA/EU guidance's
Other duties as assigned

Skills and Requirements:

BS in a scientific area
5+ years' experience in the pharmaceutical/bio-pharm manufacturing industry with at least 1 of those years at the QC manager level
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 ICH quality guidance, EU and FDA drug manufacturing regulations
Excellent written and oral communication skills.
Competency in MS Office Products and Adobe Acrobat
Independently motivated and detail oriented with good problem-solving ability
Ability to work a flexible work schedule to accommodate program priorities and international activities as needed

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Mary Jacobs at 312-291-4181 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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#Quality