Quality Compliance Officer

Netherlands, Geleen

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.

The Quality Assurance Officer in Quality Events, reporting to the Compliance Manager, is responsible to ensure GMP Compliance of the site. These include monitoring, trending, review, and timely closure of the Quality events (Deviation, Change Control, and CAPA).

The Compliance team supports the facility by investigating into non-product related non-conformance (deviation) and adverse product quality trends.

Key responsibilities:

Quality Compliance / Supplier Management:

  • Monitor Quality Performance and trends Quality Events of the site via either Trackwise or a Microsoft Excel System.
  • Serves as the Trackwise Subject Matter Expert for the site.
  • Work with the Compliance Manager and other Department Managers to ensure timely closure of all quality events such as change controls, non-conformances, investigations, corrective / preventive actions (including audit commitments), and effectiveness checks.
  • Analyze and present Quality related metrics reports, data and Key Performance Indicators (KPIs).
  • Investigate non-product related non-conformance with the required personnel / department on site to develop CAPA and effectiveness checks.
  • Frequent review into the Quality Events to ensure the Quality Events are completed to the level as required.
  • Participate in the Quality Risk Management Program and Assessment. Work with the Quality Risk Management team to develop Quality Risk Assessment Reports.
  • Work with the Compliance Manager to evaluate new Lonza Global Quality Standards, and implement locally where appropriate.
  • Participate in the internal audit programs as internal auditor, when required.
  • Perform and report Annual Product Review / Product Quality Review, when required.

People Communication:

  • Communicate potential quality risks / issues based on trends / observations to the management team.

Continuous Compliance Improvement:

  • Support in the Development and maintenance of Department Policies, SOPs, and other documents to ensure compliance to Lonza Global Quality Standards.
  • Work with team members and department managers to evaluate and identify gaps on regulatory guidelines.
  • Identify improvement opportunities in the Quality Compliance related areas.
  • Perform the improvement related activities when required.

Key requirements:

•   Ability to influence effectively across levels, functions, and sites.

•   Must have GMP, Quality, and Risk Management knowledge.

•   Compliance knowledge of regulations in multiple GMP area(s); ability to translate regulations into operational requirements (21 CFR 210, 211, 600s, 1271, as well as Eudralex Volume 4 Part 4 for ATMP Manufacture).

•   Experience in site based manufacturing or quality operations roles.

•   Ability to investigate, recognize and diagnose trends and patterns.

•   Action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, and analytical thinking.

•   Knowledge of Cell and Gene Therapy Products and Processes.

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: R21481