At Norgine, we have been transforming people's lives for over a century through innovative healthcare solutions. We are looking for an experienced Operations QA Compliance Manager to lead quality oversight across our Hengoed manufacturing site and help ensure the delivery of safe, effective and compliant products to patients., Reporting into the Quality organisation, you will provide leadership and governance for operational QA activities across manufacturing and engineering operations. You will ensure compliance with cGMP, regulatory requirements and the Pharmaceutical Quality System while promoting a culture of quality, continuous improvement and inspection readiness.,
- Lead Quality Assurance oversight of manufacturing operations and provide expert GMP guidance.
- Manage deviations, CAPAs, change controls, risk assessments and quality investigations.
- Ensure batch documentation and quality records remain compliant and inspection-ready.
- Oversee quality compliance of engineering systems, utilities and validation activities.
- Monitor quality performance metrics and drive continuous improvement initiatives.
- Support regulatory inspections, audits and licence-to-operate requirements.
- Lead, coach and develop a high-performing team, ensuring effective training and capability development.
- Partner with Operations, Engineering and cross-functional stakeholders to strengthen quality performance across the site.
Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.
Essential
- Degree in a scientific, pharmaceutical, engineering or related discipline.
- Significant experience within pharmaceutical quality assurance, manufacturing or compliance.
- Strong knowledge of cGMP regulations and pharmaceutical quality systems.
- Experience leading investigations, root cause analysis, CAPA management and change control processes.
- Working knowledge of validation, qualification, calibration and engineering compliance requirements.
- Proven ability to lead teams, influence stakeholders and drive continuous improvement.
- Strong planning, data analysis, written and verbal communication skills.
Success in this role You will thrive in this role if you:
- Hold yourself and others accountable for high standards.
- Build trust through integrity and sound decision-making.
- Are action-oriented and comfortable working in complex environments.
- Communicate effectively across all levels of the organisation.
- Collaborate to achieve shared goals while embracing diverse perspectives.
At Norgine, we encourage our people to Dare, Drive and Develop. We offer a multidimensional career where you can grow professionally, contribute to meaningful healthcare outcomes and work alongside colleagues who are passionate about making a difference for patients.
Join us and help transform lives through quality, innovation and collaboration.
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Operations QA Compliance Manager - 12 month FTC employer: Norgine B.V.
Norgine B.V. is an excellent employer that fosters a collaborative and innovative work culture, where employees are empowered to make a meaningful impact on product quality and compliance. Located in a dynamic environment, the company offers robust growth opportunities through professional development and training, ensuring that team members can advance their careers while contributing to the success of the Global Quality Team. With a strong commitment to employee well-being and a focus on teamwork, Norgine provides a rewarding workplace for those passionate about quality assurance in the pharmaceutical industry.
