QA Project Manager, PQR

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 goal of the QA Project Manager, PQR (Product Quality Review) is to assure compliance with ICH and EU regulations; commercial products are required to be periodically reviewed.  Will be responsible for management of report contributors to a defined PQR schedule, compilation and delivery of PQR report(s) as per procedure.  The PQR Quality Project Manager must be able to effectively work with internal/external personnel providing PQR Program support to meet timely report submission timelines.

Key Responsibilities:

  • Coordinate with internal and external representatives at various levels in the creation of PQR reports for commercial products manufactured at Lonza Portsmouth
  • Set up and manage PQR files
  • Support Customer PQR alignment meetings/ discussions
  • Lead PQR kickoff activities
  • Ensure PQR sections are delivered per the defined schedule, escalate accordingly.
  • Manage Asset boards/communication and report to asset of sections at risk of untimely delivery to ensure final PQR delivery date is achieved on time
  • Perform compliance review and edit PQR contributor delivered sections
  • Compile final draft of PQR and start/manage DMS workflow
  • Support process optimization activities when not directly supporting PQR report compilation activities.
  • Assist with audits of the PQR program

Key Requirements:

  • Bachelor’s Degree or equivalent experience. Preferred area of study: Scientific related field
  • Substantial experience in GMP (Good Manufacturing Practices) environment, Biopharma manufacturing background is preferred.
  • Experience in Quality Assurance or similar discipline, within biologics, biotechnology, pharmaceutical or clinical environment.
  • Project Management Skills, including Presentations, Customer Liaison, Meeting facilitation
  • Knowledgeable of the information required to be included in a PQR (including specific customer requirements)
  • Demonstrated generation of PQR schedule, proofreading, editing and management of PQR content while adhering to delivery timelines; escalates appropriately.  
  • 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. 

Reference: R31579
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