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Salary: EUR 68,600 - 119,600 / annual
Johnson & Johnson GATT Technologies is recruiting a Quality Laboratory Lead to oversee daily operations of the Quality Control (QC) team in Nijmegen, Netherlands. This role is critical to ensuring the reliability and excellence of ETHIZIA, an innovative hemostatic sealing patch used in surgical procedures worldwide.
Reporting to the Site Quality Lead, you will be responsible for managing the QC team, including training, qualification, coaching, and development of QC employees. Key responsibilities include:
• Overseeing daily QC team operations and ensuring compliance with all applicable federal, state, local, and corporate regulations
• Developing, validating, and implementing analytical methods and procedures for QC inspection, testing, and evaluation
• Reviewing and approving validation documents and user review documents
• Developing, implementing, and maintaining standard operating procedures for QC activities and equipment
• Ensuring proper equipment maintenance, calibration, and storage of QC reports, batch records, and validation documents
• Providing trend data related to QC activities (stability studies, release data) to QC/QA specialists
• Managing QC laboratory stock and consumables in cooperation with warehouse and equipment managers
• Managing the QC laboratory to ensure safe operations and high-quality control procedures
• Serving as QC representative for product release, non-conformance reports (NCR), corrective/preventive actions (CAPA), deviations, and audits
• Ensuring product release compliance and incorporating animal-derived materials into the risk management strategy per ISO 22442
• Ensuring supplier control for animal materials, intermediaries, and medical devices per ISO 22442
• Ensuring team compliance with EHS guidelines and maintaining necessary resources
• Performing other duties as assigned
Qualifications:
Education: University or technical college diploma in medicine, science, or engineering (e.g., Biology, Microbiology, Chemistry, Biochemistry, Material Sciences, Engineering—Electrical, Mechanical, Biomedical, Bioengineering, Pharmacy, Physics, Biophysics).
Required Experience and Skills:
• 5–8 years of working experience in regulated (pharma, medical device) industry, including at least 2 years in a management/supervisory role
• Working knowledge of 21 CFR Part 820, QSR, ISO 13485, SOR 98-282 CMDR (Canada Medical Device Regulations), J-PAL (Japanese), EU-MDR (European) requirements, Brazil GMP, and other applicable regulations and standards
• Leadership skills to confidently manage and support a team on a daily basis
• Strong interpersonal skills to build relationships and foster an engaged, high-performing team
• Mentoring abilities to effectively transfer knowledge and skills to team members
• Communication skills to convey information clearly across different departments
• Analytical skills to analyze processes and data for effective problem-solving
• Working knowledge of regulatory standards including ISO 13485, MDR, ISO 22442, and 21 CFR Part 820
• Openness to feedback and continuous development
• Pattern recognition to identify trends and optimize team operations
• Decision-making skills to maintain smooth workflow
• Strategic planning to prioritize tasks aligned with company goals
• Fluent in written and spoken English
Preferred:
• Thorough understanding of medically regulated plant operations, industry standards, regulations, and practices across different departments
• Experience with audits (Notified bodies and/or Competent Authorities)
• Ability to function in FDA cGMP and ISO-regulated environments and handle confidential data
• Ability to develop and enhance quality system processes while ensuring regulatory compliance
• Dutch language skills (considered a plus)
