QA Compliance Project Manager, Quality Systems
The QA Project Manager, Quality Systems is assigned as the primary liaison to internal customer(s) for all quality-related items including temporary and permanent change controls, deviations, standalone investigations, and CAPAs. Responsible to facilitate discussions between internal groups such as MSAT, Manufacturing, Engineering and QC. For these quality-related items, the Project Manager coordinates the process for owning the quality systems for Deviation, Change Control and CAPAs. Responsibilities include oversight of the system process, training, metrics, and hosting meetings (Deviation Review Board, CAPA Review Board, and Change Control Committee).
- 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.
- 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
- Substantial experience in GMP (Good Manufacturing Practices) environment.
- Biotechnology manufacturing background is preferred.
- Significant experience in Quality Assurance or similar discipline, within biologics, biotechnology, pharmaceutical or clinical environment.
- Project Management Skills, including Presentations, Customer Liaison, Meeting facilitation
- Experience with Trackwise required.
- SAP, Syncade experience preferred
- Demonstrates quality decision making
- Self-starter, excellent written and verbal communicator at all levels, able to tolerate challenging workloads and changing priorities, attention to detail, works effectively individually and with teams, positive attitude, customer focused, works well under pressure, confident making quality decisions, able to motivate others.
- Practices safety awareness at all times and considers impact of actions prior to executing activities.
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.