Quality Lab Lead: Elevate QC Operations & Team

NCSL International

Nijmegen

À distance

EUR 69 000 - 120 000

Plein temps

Il y a 3 jours
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Avantages offerts par ce poste

Annual bonus
Vacation days
Parental leave (minimum 12 weeks)

Résumé du poste

Johnson & Johnson in Nijmegen, Netherlands seeks a Quality Laboratory Lead to oversee the QC team, ensuring high-quality standards throughout the manufacturing process and regulatory compliance.

You will lead analytical method development, validations, SOP maintenance, training, and QA collaboration, supporting continuous quality improvement and timely product release in a fast-paced, regulated environment.

Qualifications

  • 5–8 years in regulated pharma/medical device industry.
  • At least 2 years in a supervisory/management role.
  • Working knowledge of 21 CFR Part 820, QSR, ISO 13485, MDR-related regulations.
  • Fluent in written and spoken English.
  • Strong leadership, mentoring and interpersonal skills.
  • Analytical mindset with data-driven problem solving.

Responsabilités

  • Oversee daily QC team operations, training, and development.
  • Develop, validate and implement QC analytical methods and procedures.
  • Review validation documents and user reviews.
  • Maintain SOPs for QC activities and equipment.
  • Ensure calibration and maintenance of QC equipment.
  • Manage QC reports, batch records, qualification and validation documents with QA.
  • Provide trend data to QA/Data & Trend Specialist.
  • Manage stock of QC consumables and equipment with owners.
  • Lead QC laboratory safety and high-quality control practices.
  • Serve as QC representative for release, NCR, CAPA, deviation, and audit activities.
  • Ensure animal-derived materials are handled under ISO 22442 compliance.
  • Maintain supplier controls for animal materials and intermediaries.

Connaissances

Quality Control
Leadership
Regulatory knowledge
English fluency
Communication

Formation

University/technical degree in medicine/science/engineering

Description du poste

Johnson & Johnson in Nijmegen, Netherlands seeks a Quality Laboratory Lead to oversee the QC team, ensuring high-quality standards throughout the manufacturing process and regulatory compliance.

You will lead analytical method development, validations, SOP maintenance, training, and QA collaboration, supporting continuous quality improvement and timely product release in a fast-paced, regulated environment.

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