Quality Assurance Project Manager
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 (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 (Manufacture, Science and Technology), Manufacturing, Engineering and QC (Quality Control).
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. The QA Project Manager leads 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.
The QA Project Manager makes 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.
- Partner with internal functional areas as part of the change control process.
- 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.
- Bachelor’s Degree or equivalent experience. Preferred area of study: Scientific related field
- 3-7 or more years in GMP environment. Minimum 3-5 years in Quality Assurance or similar discipline. Biotechnology manufacturing background is preferred
- Knowledge of GMP’s and regulations
- Project Management Experience: Presentation, Customer Liaison, Meeting facilitation
- Experience with Trackwise, SAP, Document management system preferred
- Displays a clear willingness to listen to others
- Demonstrates quality decision making
- Self-starter, solid written and verbal communication, good attention to detail, works effectively individually and with teams, positive attitude, customer focused, works well under pressure, capable of making quality decisions. Practices safety awareness at all times.
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.