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.