QA Release Supervisor

Join this innovative company with a mission to improve healthcare drastically. Our client is a global biotechnology company dedicated to treating life-threatening diseases. They are focussing on advanced cell-based immunotherapies across a diverse array of technology platforms. They apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. The

QA Release Supervisor

holds a pivotal role, ensuring the quality oversight of personalized cell therapy production for both clinical and commercial requirements within a sterile GMP environment. This position involves supervising QA release associates, collaborating with manufacturing to troubleshoot issues, and working in a shift regime to support continuous production. Key Responsibilities: Ability to read, interpret and revise documents such as SOPs, work instructions. Develop positive relationship with the QA teams, Quality Control, Information Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, and peers. Harmonize with Environmental, Health, and Safety personnel, Product Development, and Quality/Manufacturing personnel. Independently makes appropriate and compliant GMP decisions. Independently resolves problems through the use of quality systems. Develop improvement ideas and independently implement associated solutions. Support QA team development. Possess the ability to positively influence peers, key stakeholders and management. Generates shift schedules, to ensure efficient coverage for all operational needs. Maintain individual training completion in a compliant state. Supports the completion of corrective and preventive actions, as necessary. Supports internal/external audits. Supports Quality risk assessment teams. Review/approve documents as a Quality Subject Matter Expert (SME). Remain current in skills and industry trends. Detailed knowledge of Quality and Compliance standards. Required competences & skills

Education: A minimum of a Master’s Degree in Science or equivalent technical discipline is required. Experience: Minimum 6 years of relevant work experience. Preferably experienced in an aseptic manufacturing facility, particularly in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Minimum 2 years of experience with quality support in GMP manufacture is preferred. Minimum 1 year of leadership experience is required. Key Capabilities, Knowledge, and Skills: Knowledge of cGMP regulations, FDA/EU guidance, and Good Tissue Practices related to manufacturing cell-based products. Strong interpersonal and written/oral communication skills. Ability to process complex information and make critical decisions with limited information. Proficient in applying process excellence tools and methodologies. Highly organized, capable of working in a team environment, and positive attitude under supervision. Good written and verbal communication skills. Experience directly supervising employees is preferred. Familiarity with Microsoft Office applications (Outlook, Excel, Word, and Powerpoint). Interested?

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