Compliance Lead Manufacturing

Netherlands, Geleen

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza Geleen is looking for  a Manufacturing Compliance Lead to join our Manufacturing team. The MFG Compliance Lead ensures manufacturing readiness for routine GMP inspections and pre-approval inspections through ongoing inspection preparation. Manufacturing owner of Change Control and CAPA. Assists the manufacturing teams and individuals in problem-solving relating to maintaining quality compliance and has oversight SOP/SOI/WI preparation, adherence and compliance. Manufacturing point of contact for sterility assurance and quality engineering/validation activities.

Key responsibilities:

  • Manufacturing Lead accountable for continuous audit readiness for routine GMP inspections and pre-approval inspections through ongoing inspection preparation for the manufacturing facility.
  • Manufacturing responsibility for gap analysis with the SMEs (Subject Matter Experts) against standards/regulatory guidance and implementing appropriate solutions to close gap.
  • Supports consistent adherence to compliance through participation in Internal and External audits.
  • Manufacturing point of contact for Change Control and CAPA in conjunction with the wider organization support process improvement initiatives for Quality Issues.
  • Manufacturing Lead for the microbial control strategy for production processes with QA/QC specialists and accountable for executing improvements.
  • Initiation of Quality Events as NC’s, CRF’s, CAPAS as required ensuring that NC’s are raised, investigated and completed as appropriate. NC’s and CAPAs are all complete and closed within agreed due dates to ensure timely batch release/audit readiness.
  • Point of contact for the cryopreservation process for manufacturing, QE/QA Validation ensuring that activities are supported and coordinated between the departments.
  • Supports the facility through QE and shutdown activities.
  • Manufacturing Equipment Co- Ordinator (manufacturing lead responsible for equipment installation transfer in and out of the cleanroom and implementation plans) in conjunction with project and Engineering.
  • Suggesting and implementing process, planning and training improvements.
  • Identify and implement potential improvement projects, as appropriate.
  • Responsible for appropriate handover of information between involved departments.

Key requirements:

  • Bachelor degree in Biotechnology with pharmaceutical background.
  • People’s managerial skills in a complex, changing environment.
  • Mentoring skills for direct reports (Production Support leads/Associates)
  • Able to have helicopter view of departmental and site status.
  • Internal and external customer orientation.
  • Strong planning and prioritization skills.
  • Excellent problem solving skills. Pragmatic approach to change behavior or strategy based on new information.
  • Strong ability to cooperate with other departmental managers.
  • Excellent ability to communicate in both written and verbal format.
  • Positive can do attitude, good listener.
  • Able to make quality decisions independently, knows when to consult with the Quality department.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R34875