Biopharmaceutical Quality Assurance Operations Manager
2 days ago
We are seeking an experienced and seasoned QA professional to join our flagship Biologics manufacturing facility as Quality Assurance Operations Manager in Ireland. This role is crucial for leading and oversight of the production of sterile products, ensuring compliance with regulatory standards and company requirements.
Main Responsibilities:
- Ensure aseptic products meet user, regulatory, and company standards
- Oversee manufacturing compliance with EU GMP Annex 1 and FDA regulations
- Perform necessary checks, tests, and documentation for quality control
- Maintain awareness of technical and scientific advancements and keep QA and Operations teams updated
- Collaborate with global Quality Assurance, Regulatory groups, and RD teams
- Work with QA Director and Quality Control to achieve customer, quality, regulatory, and financial goals
Requirements:
- Degree in a science discipline with 7+ years of experience in the biopharmaceutical/pharmaceutical industry
- PREFERRED: MSc in Industrial Pharmaceutical Science for Qualified Person (QP) status
- 3+ years supervisory/managerial experience in Manufacturing within Biotechnology, Pharmaceutical, or medical device sectors
- Experience in drug product manufacturing processes, including aseptic filling and sterilisation operations
- Proven track record in audit and regulatory interaction management
Compensation: The estimated salary for this position is approximately €80,000 - €110,000 per annum, depending on qualifications and experience.
About Us: Lifelancer is a talent-hiring platform connecting professionals with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.
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