Manager, Quality Systems and Compliance (Cell Therapy)

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 Cell and Gene Technologies team at Lonza Portsmouth is generating hope for many patients where there are no other options to provide meaningful benefits. As a contract development and manufacturing organization, Lonza offers experts in various job functions exposure to various pharmaceutical players. In this role you will be responsible for defining and executing systems and processes that meet the highest quality standards for the development of life-saving cell and gene therapies.

The Quality Systems and Compliance Manager leads a team of QA Specialists and QA Project Managers responsible for supporting Lonza’s internal and external customers with deviation, CAPA, and change control management; review and revision of customer’s quality agreements; and preparation, review, and approval of material and lot release documentation.  The Manager ensures staff is meeting objectives and deliverables on time and in full, performs key functions such as lot release and co-chair of the Deviation Review Board, CAPA Review Board and Change Control Committee.  This position supports the overflow of tasks as needed to ensure deliverables are met.  The manager assigns the resources and priorities for the team, ensures adequate training, coaches and develops staff, and evaluates performance.  Responsible for actively pursuing opportunities for improvement and promoting a strong culture of quality awareness and GMP compliance.

Key Accountabilities

  • Provides general direction and support and acts as a point of escalation for QA staff and customers.
  • Ensures objectives are met and expectations align with customer Quality Agreements, Lonza SOPs, and regulatory requirements.
  • Identifies and implements improvements to quality processes including deployment of Cell Therapy specific Quality Systems.
  • Partners with internal customers (MSAT, Manufacturing, Engineering, QC, QO, Validation, and PP&L) to assess and resolve higher risk issues with Change Controls, Deviations, CAPA, and Investigations.
  • Attends and/or co-chairs Change Control Committee, Deviations Review Board and CAPA Board meetings.  Attends CGT Quality Council and Lot Disposition meetings.
  • Manage and track Key Performance Indicating Quality Metrics including monthly/quarterly deviation trending reports for senior site management.
  • Performs Lot Release/Disposition activities
  • Provides general direction for department.  Develops team goals, monitors progress and ensures continuous improvement.
  • Conducts regularly scheduled 1 on 1 meetings with staff, and conducts regularly scheduled team meetings to review objectives, provide support and feedback, and assistance resolving issues.
  • May participate in the hiring process, provides performance feedback, coaches, mentors and supports career development.
  • Hosts Regulatory and Customer Audits as needed and manages associated responses and CAPAs.
  • Perform other duties as assigned.

Key Requirements

  • Experience managing direct reports and demonstrated ability to mentor and coach to achieve common goals
  • Significant experience in a GMP environment
  • Biotechnology manufacturing background is preferred, especially experience with sterile manufacturing
  • Deep knowledge of GMPs and regulations.
  • Demonstrated quality decision making skills
  • Experience with TrackWise, SAP and Microsoft suite of products is desired
  • Self-motivated person with excellent written and verbal communication skills to all levels, ability to tolerate challenging workloads and changing priorities.
  • Strong attention to detail is required

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 it is 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: R28951