Quality Project Specialist Pharma

We are looking for a motivated Quality Project Specialist to join the Launch Excellence department of our client in the pharmaceutical sector.

This is a full-time position where you will play a key role in ensuring compliant, right-first-time product launches.

You will act as the independent, product-oriented quality authority, responsible for validation, registration, and implementation activities for one or more assigned launch products.

Your responsibilities will include:

Validation

• Act as the quality authority in compliance with cGMP and current regulatory expectations for:
• Process qualification/validation
• Method validation
• Filter validation
• Component qualification
• Raw material evaluation
• Design History File (DHF) reviews

Registration

• Ensure regulatory CMC (Chemistry, Manufacturing & Controls) compliance of plant processes with market registration dossiers.
• Participate in:
• Data verification and QA review of initial marketing authorizations, variations, and responses to health authority queries
• Compliance checks between registration dossiers and site practices

Implementation

• Oversee the correct and timely implementation of approved regulatory changes on site, including follow-up on approvals and commitments across different markets.

Experience & Skills:

• Master’s degree in a scientific discipline (e.g., Pharmacy, Biomedical Sciences, Bio-engineering)
• Ideally 2 years of relevant experience in the pharmaceutical or medical device industry, or equivalent through a PhD
• Specific experience or interest in Quality Assurance, Compliance, and Regulatory Affairs (CMC) for (Bio-)Pharmaceutical products
• Strong quality mindset and pragmatic approach
• Excellent analytical, problem-solving, communication, and interpersonal skills
• Solid scientific knowledge and ability to work cross-functionally
• Fluency in Dutch and English
• Strong knowledge of cGMP, regulatory guidelines, and relevant medical device/combination product regulations

Offer:

As a Project Specialist:

• Permanent contract with us, including:
• Monthly expense allowance
• Company car & fuel card (or monthly gross bonus)
• €8 meal vouchers
• Group & hospitalization insurance
• Mobile phone subscription
• Year-end bonus
• Access to Benefits at Work, sports & culture vouchers, and eco vouchers
• Dynamic training program (job-specific & professional courses)
• Regular feedback and career guidance from your HR Business Partner
• Networking events and team-building activities with fellow specialists
• Kickstart your career with our exclusive 2-day Bootcamp
• Extra career flexibility: Not a consultant at heart? After one year, there’s always the possibility to join the client’s team directly as a permanent employee.

As a Freelancer:

• Use the USG EASY app to:
• Receive tailored project offers based on your profile and availability
• Track your invoicing process transparently
• Manage all admin in one platform
• Attend Innovation Meetups to network with top companies and peers

If you want to make a real impact in launching high-quality, compliant pharmaceutical products, we’d love to hear from you.