Quality Laboratory Lead

Johnson Johnson; Nijmegen; Presencial; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

Johnson & Johnson GATT Technologies is recruiting a Quality Laboratory Lead for Nijmegen, Netherlands. The role will oversee the QC team and ensure reliability and regulatory compliance for ETHIZIA, our hemostatic sealing patch.

You will drive method development, validation, and batch release activities to support high-quality medical devices. The position involves leading staff, aligning QC processes with GATT's strategy, and implementing continuous quality improvements in a fast-paced,

Formación

• 5-8 years of experience in regulated pharma/medical device industries.
• At least 2 years in a management/supervisory role.
• Knowledge of GMP/QSR and ISO 13485 is required.

Responsabilidades

• Oversee daily QC team operations, training, and development.
• Develop, validate, and implement QC analytical methods and procedures.
• Review and approve validation documents and QC records.
• Maintain and improve QC SOPs and calibration programs.
• Ensure proper storage and handling of QC reports and batch records.
• Lead supplier and material controls within ISO 22442 guidelines.

Conocimientos

Quality management

Regulatory knowledge

Leadership

Educación

Biology / Microbiology degree

Descripción del empleo

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.

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

People Leader

All Job Posting Locations:

Nijmegen, Netherlands

Job Description:

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.

Role summary

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.

Key responsibilities include:

• 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

Qualifications

Education:

• 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.

Experience and Skills

Required:

• 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 Regula