Transform Lives. Drive Quality. Develop People.
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.
We are a company built on three core values:
Drive - Take ownership, deliver results and make decisions that matter.
Dare - Challenge the status quo, embrace innovation and demonstrate courage.
Develop - Collaborate, value different perspectives and help others reach their potential.
The Role:
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.
Requirements
Key Responsibilities
- 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.
Skills & Experience
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.
Why Norgine?
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.
This advert summarises the key responsibilities of the role and is not exhaustive. Responsibilities may be adjusted to meet business and organisational needs.
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Benefits
Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.
Sound good? Find out more about the career you’ll have with Norgine, then apply here.
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Skills Required
- Degree in a scientific, pharmaceutical, engineering, or related discipline
- Significant experience in 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 communication, and verbal communication skills
What We Do
Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. Our commitment to transforming people’s lives drives everything we do and our European experience, fully integrated infrastructure and exceptional partnership approach enables us to quickly apply creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access. Norgine is proud to have helped 24 million patients around the world in 2021 and generated €505 million in net product sales, a growth of 10% over 2020. Norgine has a direct presence in 16 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing infrastructure. This enables us to acquire, develop and commercialise specialist and innovative products that make a real difference to the lives of patients around the world. In 2012, Norgine established Norgine Ventures, a complementary business which supports innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.
