Senior Manager, Quality Assurance

Proclinical is seeking a Senior Manager, Quality Assurance for a cutting-edge biotech company located in Cranbury, NJ.

The incumbent will ensure conformance to quality standards and regulatory requirements while developing and continually improving quality systems and related processes such as validation, material control and disposition, risk management and training.

Must be eligible to work in the US.

Job 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

Skills and 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.
• Demonstrated ability to think and communicate clearly.
• Ability to work as part of a cross-functional team in a dynamic, fast-paced environment

If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at +(1) 617-830-1769 or b.forsen@proclinical.com.

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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