Quality Assurance Manager
vor 2 Wochen
We are seeking a highly skilled Quality Support Manager to join our team at UCB-Pharma SA. As a Quality Support Manager, you will play a critical role in ensuring the quality of drug substances and drug products throughout the manufacturing process.
Key Responsibilities- Manage a team of 8 colleagues, 2 specialists, and 6 coordinators to ensure the quality of drug substances and drug products.
- Develop and implement efficient organizational systems to achieve operational goals and objectives.
- Collaborate with internal partners (Production, Supply) and external partners (Commercial Partners) to ensure seamless communication and quality control.
- Responsible Person for handling of 'narcotics' (controlled substances) and interaction with Swissmedic.
- Ensure compliance with FDA, European, and Japanese regulatory requirements.
- Develop and implement training programs to enhance the skills and abilities of team members.
- Conduct regular audits and inspections to ensure quality standards are met.
- Master's degree in a relevant Life Sciences, Quality, Chemical, or Biochemical engineering discipline.
- Minimum 5 years of experience in GMP regulated environments, with experience in team management and technical competencies in the pharmaceutical industry.
- Experience with FDA, European, and Japanese investigators during on-site inspections, and experience interacting with Regulatory review staff on submission issues.
- Strong analytical, troubleshooting, and problem-solving skills.
- Excellent interpersonal, verbal, and written communication skills in French and English.
UCB-Pharma SA is a global biopharmaceutical company focused on neurology and immunology. We are committed to creating value for our patients, employees, and the planet. We offer a caring and supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work.
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