Global Quality Operations Manufacturing Senior Specialist

Galapagos , d Generaal De Wittelaan L11 A3 2800 Mech Amsterdam, Zuid-Holland 4056 NL

Posted: 11/04/2025 2025-11-04 2025-12-05 Employment Type: Contract Job Category: Quality and Compliance Job Number: 623648 Is job remote?: Hybrid Country: Netherlands

Job Description

Join Our Team as a Global Quality Operations Manufacturing Senior Specialist

Are you a seasoned quality professional seeking a dynamic role in the biotech manufacturing landscape? We are looking for a dedicated and detail-oriented Global Quality Operations Manufacturing Senior Specialist to play a pivotal role in ensuring the highest standards of GMP compliance and quality in ATMP manufacturing. This 6-month consulting opportunity offers you the chance to contribute to innovative projects, optimize quality processes, and work within a collaborative environment that values your expertise.

What You Will Do:

• Review and oversee ATMP manufacturing batch records to ensure accuracy and compliance
• Manage deviations, CAPAs, and change control processes to uphold quality standards
• Monitor and review clinical batches across connected DMUs, ensuring adherence to GMP regulations
• Serve as QA representative for Kitting, SAP-related activities, and supply chain processes, including batch review and SAP release of kits
• Oversee SAP BOM activation/inactivation, audit trails, and procedure approvals related to Kitting and Supply Chain
• Facilitate block/unblock activities and manage return shipments logs for effective quality control
• Identify opportunities for continuous improvement in GMP manufacturing processes

Required Skills:

• Bachelor’s or Master’s degree in Biology, Biotech Sciences, Chemistry, or related field
• 3-5 years of experience working within a GMP environment, with a solid understanding of cGMP QA processes
• Proven experience in ATMP manufacturing and commercial GMP settings
• Strong knowledge of deviations, CAPAs, change controls, and QA documentation
• Excellent attention to detail and problem-solving skills
• Effective communication and collaboration abilities

Nice to Have Skills:

• Experience with SAP systems, particularly in a GMP manufacturing context
• Familiarity with clinical batch review processes
• Prior involvement in quality management activities related to kitting and supply chain

Preferred Education and Experience:

• Bachelor’s degree in a relevant scientific discipline; Master’s degree preferred
• 3 to 5 years of hands-on GMP QA experience, ideally within ATMP or cell therapy manufacturing

Other Requirements:

• Willingness to work in Leiden on a full-time basis for the duration of the contract
• Ability to coordinate across multiple departments and manage documentation rigorously
• Knowledge of industry regulations and compliance standards

If you're ready to leverage your expertise in a challenging and rewarding environment, we encourage you to apply now. Join us in shaping innovative therapies and making a meaningful impact in healthcare!

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

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