QA Release Supervisor
il y a 2 semaines
QA RELEASE SUPERVISOR
- Biotechnology- GhentABOUT THE COMPANY
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.
- 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.
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