Senior QA Specialist – Digital Manufacturing Transformation (Pharmaceuticals) NL/EN

Are you a seasoned Quality Assurance professional with a passion for pharmaceutical manufacturing and digital innovation?

For a leading pharmaceutical client in the Antwerp region, Hays is looking for a Senior QA Specialist to play a pivotal role in a major digital transformation: the implementation of a new Manufacturing Execution System (MES).

Depending on your background, you will act as the key Quality partner within either Pharmaceutical Packaging / Device Assembly or Sterile / Aseptic Manufacturing. Prior MES experience is not required, we are looking for your strong QA foundation, business acumen, and ability to bridge the gap between Quality, Operations, and IT.

Your new role

As a Senior QA Specialist, you will ensure that manufacturing processes, master data, and digital workflows within the new MES environment fully comply with GMP and regulatory standards. You won't just review documents from behind a desk; you will actively shape the future of pharmaceutical production.

Your responsibilities will include:

• Driving Quality in digitalisation: Providing hands-on Quality support and oversight throughout the MES implementation.
• Multidisciplinary collaboration: Actively participating in interactive workshops, brainstorming sessions, and design discussions alongside IT developers, MES modelers, Operations, and fellow QA colleagues.
• Approving critical data: Reviewing and approving quality-relevant master data, manufacturing instructions, process changes, and GMP documentation.
• Optimising workflows: Identifying bottlenecks and helping to streamline review and approval processes for the site of the future.
• Stakeholder alignment: Acting as the main Quality Point of Contact, building strong partnerships, and influencing stakeholders to achieve compliant, win-win solutions.
• Risk-based decision-making: Making pragmatic, well-informed Quality decisions in a fast-paced, dynamic production environment.

Your profile

You are a senior QA expert who thrives in a collaborative environment. You enjoy translating complex quality regulations into practical digital solutions and have the communication skills to get people on board.

More specifically, you bring:

• A Master’s degree in pharmaceutical, chemical, or biological sciences, engineering, or a related scientific field.
• 5 to 10 years of experience in Quality Assurance within the pharmaceutical industry.
• Solid expertise in pharmaceutical packaging / device assembly and/or sterile / aseptic manufacturing (including strong knowledge of EU GMP Annex 1).
• Thorough knowledge of cGMP legislation, ICH guidelines, batch records, and batch release activities.
• Strong IT affinity: You do not need prior MES experience, as you will be trained on the system, but you pick up new software easily and enjoy working on digital processes.
• Workshop & influencing skills: You love brainstorming in multidisciplinary teams and possess strong persuasion skills to align IT, Operations, and Quality.
• An analytical, proactive mindset with the ability to manage changing priorities and make risk-based decisions under pressure.
• Fluency in Dutch and a good command of English (both written and spoken).

What you'll get in return

You will step into a high-impact role where you have the unique opportunity to help build a state-of-the-art digital production environment from the ground up at a leading pharmaceutical player. While you bring your strong QA expertise to the table, you will receive full training on the new MES system and collaborate closely with leading experts across Quality, Operations, and IT to shape the production site of the future. In return for your contribution, we offer a competitive salary package complemented by comprehensive extralegal benefits, including a company car.

Ready to take the lead in the digital transformation of pharmaceutical quality? Apply now or contact us for a confidential conversation!