QA Project Manager, Inspection and Audit Management

United States, Portsmouth (New Hampshire)

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 Quality Project Manager for inspection and audit management interacts directly with internal/external stakeholders and customers on various project teams and serves as a quality subject matter expert for quality issues. Will serve as a liaison for internal Lonza quality and customer quality preparing for and hosting audits as well as for managing post-audit activities. The Project Manager will ensure superior customer service to internal and external customers.

Key Responsibilities:

  • Participation in Internal and External audits
  • Ensures readiness for routine GMP inspections and pre-approval inspections through ongoing inspection preparation
  • Supports consistent adherence to compliance regulations
  • Assists teams and individuals in problem-solving relating to maintaining quality compliance
  • Participates in the planning of inspection logistics and communications
  • Identify issues of concern and partners with internal personnel to address as appropriate to ensure compliance
  • Implement effective corrective and preventative actions to deficiencies as required

Key Requirements:

  • Bachelor’s Degree or equivalent experience. Preferred area of study: Scientific related field
  • Substantial experience in a GMP (Good Manufacturing Practices) environment
  • Significant experience working within quality assurance or similar discipline
  • Biotechnology manufacturing background preferred
  • Experienced with Trackwise, SAP, Syncade and Microsoft Suite preferred
  • Strong attention to detail and organizational skills
  • Ability to manage tasks independently and make independent quality decisions
  • Excellent written and verbal communication skills
  • Able to tolerate challenging workloads and changing priorities effectively

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: R22712