QA Compliance Project Manager

United States, Portsmouth (New Hampshire)

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 Compliance Project Manager is assigned as the primary liaison to an external customer (or customers) 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. The QA Compliance 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 Compliance Project Manager also identifies opportunities for improvement with Lonza quality systems and/or customer interactions, leads the improvement project team in defining and implementing effective solutions. The Project Manager requires little to no guidance on quality decision making or problem-solving and will define the strategy for the remediation of issues.  The Project Manager mentors less experienced QA Project Managers and/or members of the Compliance team and can act as a delegate for the department manager.

Key responsibilities:

  • Interacts with internal and external customers as part of joint and internal project teams serving as the Quality Subject Matter Expert (SME) for any customer related quality issues

  • Partners with internal customers such as MSAT, Manufacturing, and Engineering etc. as part of the change control process serving as the Quality SME and/or final QA approver.

  • Supports the Deviation, Investigation, and CAPA processes specific to their assigned customers; reviews and approves investigation reports including root cause analysis and assures corrective and preventive actions address the root cause to prevent recurrence.

  • 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

  • Mentors more junior QA Project Managers and Compliance Specialists.

  • Acts as the Compliance Manager delegate when requested including meeting coverage and delegation of tasks.

Key requirements:

  • Bachelor’s Degree or equivalent experience. Preferred area of study:  Scientific related field

  • Extensive experience in GMP environment

  • Substantial experience in Quality Assurance

  • Biotechnology manufacturing background is preferred

  • Project Management including public speaking/presentation skills, building and maintaining strong Customer relationships, meeting facilitation

  • Experience with Trackwise, SAP, Syncade and Microsoft Suite preferred

  • Detail-oriented

  • Organized

  • Self-motivated

  • Displays a clear willingness to listen to others and is able to successfully train others

  • Demonstrates quality decision making

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. 

Reference: R38778