Quality Laboratory Lead

• 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.

Compliance Management, Leadership, Quality Standards, Standard Operating Procedure (SOP), Team Management

• 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.

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees' and companies' performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location's eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

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.

Quality

Quality Control

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

People Leader

Nijmegen, Netherlands

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.

• 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
• undefined

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

Quality Control (QC)

€68 600,00 - €119 600,00