Quality Laboratory Lead

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

J&J GATT Technologies is recruiting for a Quality Laboratory Lead, located in Nijmegen, Netherlands.

Join our dynamic team as a Quality Laboratory Lead and play a pivotal role in ensuring the reliability and excellence of ETHIZIA, our innovative hemostatic sealing patch. Your expertise will directly impact patient outcomes, making a difference in surgical procedures worldwide while advancing the field of medical technology.

The Quality Laboratory Lead (in GATT Technologies SOPs, also referred to as Quality Control (QC) Manager) is responsible for overseeing the daily operations of the QC Team.

Reporting to the Site Quality Lead, this role ensures that high-quality standards are maintained throughout the product manufacturing process and that all activities comply with applicable regulatory requirements.

The Quality Laboratory Lead is also accountable for optimizing QC systems and processes to align with GATT’s strategy and mission, supporting continuous quality improvement. In addition, this role is responsible for preventing quality issues and avoiding regulatory compliance actions by government agencies.

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• →Responsible for the daily operations of the QC team including proper training/qualification, coaching, and development of the QC employees.
• →Responsible for the development, validations and implementation of (analytical) methods and procedures of QC (routine) inspection, testing, and evaluation.
• →Reviewing and approving validation documents and user review documents.
• →Ensuring proper development, implementation, and maintenance of standard operating procedures for QC activities, including procedures for equipment.
• →Ensuring the equipment maintenance and calibration are performed.
• →Evaluating and ensuring the correct storage of QC reports/documents, including batch records (in cooperation with QA), qualification reports (IQ, OQ, PQ), and validation documents.
• →Assisting and providing trend data related to QC activities, such as stability studies and release data of intermediates, and final products to QC/QA Data & Trend Specialist.
• →Responsible for stock management of QC consumables, requisites, and equipment in cooperation with the designated owners (e.g., warehouse manager or QC equipment owners).
• →Managing the QC laboratory to ensure safe operations and high-quality control procedures.
• →QC representative for release, NCR, CAPA, deviation, and audit activities.
• →Responsible for product release and for ensuring that animal-derived materials are incorporated into the risk management strategy within the GATT Technologies QMS in compliance with ISO22442 “Medical Devices Utilizing Animal Tissues and their Derivatives”.
• →Ensure supplier control specifically for suppliers of animal materials, intermediaries, and medical device in compliance with ISO 22442 “Medical Devices Utilizing Animal Tissues and their Derivatives.”
• →For those who supervise or manage staff, responsible for ensuring that subordinates follow EHS guidelines and that all necessary resources are available and maintained in good condition, if applicable.
• →Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• →Performs other duties assigned as needed

• Holds a diploma from a university or technical college in medicine, science, or engineering, e.g.  Biology, Microbiology, Chemistry, Biochemistry, Material Sciences, Engineering - Electrical, Mechanical, Biomedical, Bioengineering, Pharmacy, Physics, and Biophysics.

• 5-8 years of working experience in regulated (pharma, medical device) industry, including at least 2 years specific experience in 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, and knowledge of Brazil GMP and other applicable regulations and standards.

• Leadership skills to confidently manage and support a team on daily basis.
• Strong interpersonal skills to be able to build relationships on both a personal and professional level to foster an engaged, high-performing team.
• Mentoring abilities to effectively transfer knowledge and skills to the team members.
• Communication skills to be able to convey information clearly and appropriately across different departments to achieve shared goals.
• Analytical skills to accurately analyze processes and data to support effective problem-solving when issues arise.
• Working knowledge of regulatory standards, including ISO 13485, MDR, ISO 22442, and 21 CFR Part 820.
• Openness to feedback to accept and act on feedback to continuously develop both soft and hard skills.
• Pattern recognition to identify trends and opportunities to optimize daily team operations.
• Decision-making skills to quickly assess needs to maintain a smooth workflow.
• Strategic planning to prioritize tasks in alignment with company goals, considering both long-term objectives and daily/weekly activities.
• Fluent in written and spoken English
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• Thorough understanding of medically regulated plant operations, including knowledge of industry standards & regulations, processes and practices in a variety of different departments and operations.
• Experience with audits (Notified bodies and/or Competent Authorities).
• Ability to function in a controlled manner regulated by FDA cGMPs & ISO standards, and handle confidential data.
• Ability to develop and/or enhance quality system processes while ensuring compliance to applicable regulatory standards.

• Language required: English – Dutch is considered a plus.