Manufacturing Jobs in Alkmaar, Netherlands (Now Hiring) — 6 open

Drive meaningful change

Are you ready to combine your role as Qualified Person with leading and developing a team of experienced QPs in an international environment? We are looking for an experienced and people-oriented Manager, who ensures compliant batch release decisions while strengthening the capabilities, consistency and collaboration within the Batch Release team. In this role, you will contribute directly to safeguarding patient safety and maintaining the highest quality standards across our supply chain.

Get a glimpse of the team

You will be based in Alkmaar and become part of the Global Batch Release department, reporting directly to the Director of Batch Release. You will lead and support a team consisting of Qualified Persons and collaborate closely with QA colleagues, Operations teams and international stakeholders across the Abacus Medicine Group.

Your main responsibilities

As Manager Qualified Person you combine your responsibilities as a certified Qualified Person with leading and developing a team of experienced QPs. You are responsible for the certification and release of medicinal products in accordance with applicable legislation and GMP requirements. Ensuring that products are only released when all quality and regulatory requirements have been met. You review and approve manufacturing documentation, batch records and other GMP-related documentation and oversee the proper retention of batch documentation and samples. In addition, you provide guidance and final approval for deviations, CAPAs and Change Controls and contribute to maintaining and continuously improving the Quality Management System.

Alongside your operational responsibilities, you play a key role in strengthening the capabilities and collaboration within the Batch Release organisation. You coach and develop the QP team, foster a positive and high-performing team culture and ensure competencies remain up to date through ongoing development and performance management. You work closely with internal stakeholders across Quality and Operations as well as with external manufacturing partners and health authorities to ensure efficient and compliant release processes. Furthermore, you support and coordinate inspections and audits and actively identify opportunities for continuous improvement across processes, systems and ways of working.

Fuel for your success in the role, we imagine you have:

• A university degree in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology;

• A valid Qualified Person status and several years of experience acting as a QP within the pharmaceutical industry;

• Extensive knowledge of EU-GMP requirements and a strong understanding of applicable ICH and WHO guidelines;

• Experience in leading, coaching and developing professionals within a quality environment;

• Fluency in both Dutch and English;

• Strong decision-making skills combined with a pragmatic and risk-based mindset;

• Experience with quality systems, audits, deviations, CAPAs and Change Controls;

• Willingness to complete and maintain all required GMP and GDP training courses.

Interested?

If you want to apply for the position, please follow the link and attach your CV and cover letter.

Would you like to know more about us?

Follow us on Instagram and LinkedIn and get an insight into everyday life at Abacus Medicine. For job openings, check our Career page.

Moving Healthcare. Moving You.

In Abacus Medicine Group, you’ll experience the power of Moving Healthcare. With our change mindset, we're moving the industry and improving healthcare as we broaden access to medicine.

But it's not just about moving healthcare, it's about Moving You. You’ll be part of a caring community of more than 1,800 people across the World. With us, you will be valued, empowered, and have a direct impact on driving change. Let's access the future of medicine and make a difference together. Your move.

Applications will be reviewed on an ongoing basis, so we encourage you to apply as soon as possible!