Oorspronkelijke vacature omschrijving:

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.

Here at Lonza we have an exciting opening for a Quality Assurance Project Manager II to join us on site in Geleen on a full time basis. The QA Project Manager is assigned as the primary liaison to an external customer(s) for all quality-related items including temporary and permanent change controls, deviations, standalone investigations, CAPAs, Product Quality Reviews and Quality Agreements and facilitates discussions between customers and internal groups such as MSAT, Manufacturing, Engineering and QC. For these quality-related items, the incumbent manages the process for notifying the customer and assuring the customer’s feedback and comments are addressed, verifies that the quality records are complete; that there is sound justification/scientific rationale, that root cause analysis and corrective and preventive action is appropriate and, where applicable, that customer approval is received.

You will be leading Joint Quality Team meetings –establishes agendas, publishes meeting minutes and tracks action items; participates in Internal and Joint Project Team (IPT/JPT) meetings as the QA representative and tracks and publishes monthly and quarterly quality KPIs. As QA Project Manager you are responsible to make quality decisions and performs problem-solving however high risk items such as major or critical deviations, change controls and CAPA will require input and agreement from the department manager.

Key responsibilities:

• Partner with internal functional areas as part of the change control process.
• Participates in departmental Functional Leadership Team meetings and provides input on departmental strategic decisions.
• Manage projects from concept to completion; create and manage project plan, work cross functionally to ensure right first time and provide adequate training to impacted areas
• Support the Deviation, Investigation, and CAPA processes specific to their assigned customers; review and approve investigation reports including root cause analysis and assure corrective and preventive actions address the root cause to prevent recurrence
• Interact with internal and external customer as part of Joint and Internal project Teams serving as the Quality Subject Matter Expert for any customer related quality issues.
• Track and present customer metrics.
• Review and approve various product specific documents such as Quality Agreements, Product Quality Reviews etc.
• Support customer audits.

Key requirements:

• Bachelor’s Degree or equivalent experience. Preferred area of study: Scientific related field
• Significant experience in GMP environment and Quality Assurance or similar discipline. Biotechnology manufacturing background is preferred
• Knowledge of GMP’s and regulations
• Project Management Experience: Presentation, Customer Liaison, Meeting facilitation
• Demonstrates flexibility to adapt to changing business priorities.
• Ability to work inter-departmentally and with customers.
• High level of suite specific operations and technical skills.
• Demonstrates role model behaviors for operating in a GMP manner.
• Demonstrate ability for effective Planning, Organizing and Controlling competency
• Demonstrate sound decision making, considering broad scope of factors
• Able to manage multiple priorities and achieve results.
• Good ability to complete assignments under tight timelines, and work under pressure.
• Demonstrates knowledge on continuous improvement within the adherence to standardized procedures & cGMP compliance
• Experience with Trackwise, SAP, Document management system preferred
• Detail-oriented
• Self-motivated
• Displays a clear willingness to listen to others
• Self-starter, solid written and verbal communication, good attention to detail, works effectively individually and with teams, positive attitude, customer focused, Practices safety awareness at all times.

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.