QA Project Manager
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.
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. Responsible to facilitate 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. 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 Quality Compliance Project Manager interacts directly with Lonza's internal and external customers on change management, projects, deviations, standalone investigations and CAPAs and contributes to the decision making for compliance related quality issues. Capable of reviewing investigation reports and root cause analysis for low and medium risk/minor and major deviations to assure corrective and preventive actions will prevent recurrence however high risk and critical deviations require review by a QA PM3 or department manager.
Responsibilities:
- 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.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations
- Perform other duties as assigned.
Key Requirements:
- Bachelor’s degree. Preferred area of study: Scientific related field
- 5-10 years of experience in GMP
- Ability to balance and prioritize tasks
- Willingness to ask questions and/or to seek input from more experienced peers and management
- Ability to maintain and build internal and external relationships, works effectively individually and with teams
- Questioning attitude and critical thinking required to make quality related decisions
- Displays a clear willingness to listen to others
- Demonstrates quality decision making
- Self-starter
- Solid written and verbal communication, good attention to detail
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.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.