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Snr QA Release Manager
- Posted: 07/07/2024
- Salary: Competitive
- Location: Geel, Belgium
- Job Type: Permanent/Fixed Term
We're seeking a Sr QA Release Responsible for New Product Introduction to join our clients Quality team. You'll oversee the development and clinical supply chain activities for Small Molecule Active Pharmaceutical Ingredients (SM-API), ensuring compliance and excellence from early development through to commercial supply.
Your role:
- Quality Oversight - Manage the quality of a defined API product portfolio throughout its development phase. Oversee the development of products across three pilot plants (two in Beerse, one in Geel).
- Manufacturing Excellence - Prepare batch records, investigate and resolve quality issues post-production.
- Product Release & Changes - Monitor product performance, manage changes, and release complex, low-volume batches of new modalities such as peptides, oligonucleotides, nucleotides, and chemical synthetics.
- Team Collaboration - Align with production and other departments, drive solutions for product-related issues.
- Continuous Improvement - Foster innovation, adapt to new challenges, stay current with industry trends, and implement phase-appropriate GMP procedures.
Ideal Candidate:
- Degree in a scientific field such as BPharm, MPharm, Bioengineering, Chemical engineering, Biology, Chemistry or similar. Industrial Pharmacist with EU certified Qualified Person status is a plus.
- Several years 'in Chemical/Pharmaceutical Supply Chain or Quality Assurance, with a strong focus on QA release experience.
- Experience in both R&D and commercial quality settings, with a keen understanding of quality assurance in a research and development context.
- Strong analytical skills, solution-oriented mindset, and ability to make risk-based decisions under pressure.
- Excellent negotiation, communication, and presentation skills across all organizational levels.
- In-depth knowledge of cGMP (domestic & international), ICH guidelines, policies, and Quality Systems. Experience with regulatory inspections and project management skills.
- Agile, scientifically-minded, flexible, mature, and a team player.
Your role:
- Quality Oversight - Manage the quality of a defined API product portfolio throughout its development phase. Oversee the development of products across three pilot plants (two in Beerse, one in Geel).
- Manufacturing Excellence - Prepare batch records, investigate and resolve quality issues post-production.
- Product Release & Changes - Monitor product performance, manage changes, and release complex, low-volume batches of new modalities such as peptides, oligonucleotides, nucleotides, and chemical synthetics.
- Team Collaboration - Align with production and other departments, drive solutions for product-related issues.
- Continuous Improvement - Foster innovation, adapt to new challenges, stay current with industry trends, and implement phase-appropriate GMP procedures.
Ideal Candidate:
- Degree in a scientific field such as BPharm, MPharm, Bioengineering, Chemical engineering, Biology, Chemistry or similar. Industrial Pharmacist with EU certified Qualified Person status is a plus.
- Several years 'in Chemical/Pharmaceutical Supply Chain or Quality Assurance, with a strong focus on QA release experience.
- Experience in both R&D and commercial quality settings, with a keen understanding of quality assurance in a research and development context.
- Strong analytical skills, solution-oriented mindset, and ability to make risk-based decisions under pressure.
- Excellent negotiation, communication, and presentation skills across all organizational levels.
- In-depth knowledge of cGMP (domestic & international), ICH guidelines, policies, and Quality Systems. Experience with regulatory inspections and project management skills.
- Agile, scientifically-minded, flexible, mature, and a team player.
Hannah Hughes
Team Lead/Senior Consultant