Sr. Manager, Quality Assurance job in Cranford, USA

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Job type: Permanent

Discipline: Senior/Director & VP

Location: United States

This vacancy has now expired. Please see similar roles below...

̽��ϼ� are seeking a Senior Manager, Quality Assurance responsible for in-house and outsourced activities supporting our GMP viral vector drug substance manufacturing and testing facility.

Responsibilities:

Provide support for the transition from phase-appropriate to commercial expectations for site-related GMP activities
Perform equipment, utility, and facility qualification/validation protocol review and approval including both pre and post execution. Support closure of exceptions and approval of final reports.
Perform product release activities, including reviews of batch records, and other documentation for product release/disposition.
Assess and approve analytical related documents, including validation protocols/reports, stability, shelf-life extension, drug substance and drug product testing data and OOS
Assess change controls for risks and impact on processes, product, and programs
Pro-actively identify and escalate business-critical issues affecting Compliance, Operations, and Quality Assurance
Review raw data and data summaries presented in internal reports and regulatory submissions
Work with subject matter experts to define and implement process and procedure improvements
Review and approve SOP's, specifications, and other controlled documents
Provide support with tracking and trending deviations, corrective actions, and process data
Provide support to ensure audit observations, changes, and corrective actions are addressed and closed in a timely manner
Provide support for reviews of product and program risk, working with subject matter experts and key stakeholders to ensure communication and timely follow-up of mitigation activities
Provide support with coordination and execute quality assurance activities during technology transfer projects

Requirements:

BS degree (minimum) in biological sciences or related field of study. Advance degree is a plus
8+ years of relevant experience in biological sciences or biotechnology within quality assurance, quality control, biomanufacturing, clinical and/or regulatory operations.
6 + years of experience with Masters degree in biological sciences or biotechnology
Preference given to candidates with +3 years of cell and gene therapy experience, in manufacturing, Quality Control or Quality Assurance
Hands-on experience in the interpretation and application of cell and gene therapy regulations and guidance documents
Thorough knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines as they apply to drug manufacturing and aseptic processing
Demonstrated ability to interpret and apply pharmaceutical industry regulatory compliance requirements with an emphasis on US and EU GMP/GLP/GCP regulations.

If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at Bo.forsen@proclinical.com

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

̽��ϼ� Staffing is an equal opportunity employer.

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