Sr. Manager, Quality Assurance

Proclinical 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

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.