QA Project Manager
United States, Portsmouth (New Hampshire)
The QA (Quality Assurance) Project Manager (PM) 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 (Corrective and Preventative Action), Product Quality Reviews and Quality Agreements and facilitates discussions between customers and internal groups.
For these quality-related items, the QA Compliance PM will manage 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.
- Lead 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
- Partners with internal customers as part of the change control process serving as the Quality subject matter expert and/or final QA approval
- Supports the Deviation, Investigation, and CAPA processes specific to their assigned customers; reviews and approves investigation reports
- Manages and tracks customer Key Performance Indicator quality metrics
- Reviews and approves various product specific documents as needed such as Quality Agreements, Product Quality Reviews etc.
- Identifies opportunities for improvement, defines the project plan, scope, and deliverables
- Represents department at site meetings (lot release, CC and CAPA board)
- Supports Customer audits and Regulatory inspections
- 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, SAP, Syncade and Microsoft Suite 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.
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.