QA Manager, Raw Materials

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 Assurance-Raw Materials Manager is responsible for providing strategic, tactical and objective leadership for Quality Operations staff directly supporting Manufacturing Operations. This roles key deliverables are to provide general leadership, guidance and support to ensure staff is meeting QA objectives and deliverables on-time and in-full.

The Manager will provide guidance for the entire team with regards to the vision of the department and develop the roadmap to achieve the goals.  The Manager will look for opportunities for the staff to participate in ongoing continuous improvement opportunities that are specific to the team as well as the individual contributors.  

Key Responsibilities:

  • Provide general leadership, guidance and support to ensure staff is meeting QA objectives and deliverables on-time and in-full, perform key functions and support overflow of tasks needed to ensure deliverables are met, manage and track key Performance Indicator metrics for Quality.
  •  Review material release documentation as well as other ancillary attachments such as vendor technical documentation, certificate of analysis/compliance and confirmatory test results, in order to ensure the timely release of raw material for production.  
  • Provide guidance for the entire team with regards to the vision of the department and develop the roadmap to achieve the goals.  
  • Identify opportunities for the staff to participate in ongoing continuous improvement opportunities that are specific to the team as well as the individual contributors.
  • Provide guidance to the supervisors, provide support and will review the material process as a whole to determine where efficiencies in the system are required.
  • Provide vision for the QA Material department and Supervisor.  Seek continuous improvement through team goals.
  •   Develop innovative process that allows for the continuity of the department and to facilitate reduction of cycle time.
  • Work with internal partners to ensure continuous improvement for the Quality Review of records and the review of master batch records. 
  • Engage internal partners in dialogue regarding continuous improvement of both.
  • Review and give final approval on Master Batch Records
  • Develop and maintain continuous tracking of the Review process to realize potential efficiencies in the system and work with internal teams to implement efficiencies
  • Participate in all teams as requested to include: Deviation Reduction, Process Improvement
  • Provide vision for the QA Material department and Supervisor.  Seek continuous improvement through team goals.  Develop innovative process that allows for the continuity of the department and to facilitate reduction of cycle time.
  • Work with internal partners to ensure continuous improvement for the Quality Review of records and the review of master batch records.  Engage internal partners in dialogue regarding continuous improvement of both.
  • Reviewer and final approver on Master Batch Records
  • Develop and maintain continuous tracking of the Review process to realize potential efficiencies in the system.  Once identified work with internal teams to implement efficiencies
  • Participate in all teams as requested to include: Deviation Reduction, Process Improvement

Key Requirements:

  • Bachelor’s Degree or equivalent experience.  Preferred area of study:  Engineering or Scientific related field
  • Substantial experience in GMP environment; Biotech/Pharmaceutical preferred.
  • Significant experience managing direct reports
  • Pharmaceutical manufacturing background is preferred
  • Excellent knowledge of GMP’s and regulations. Demonstrated critical thinking, decision making and analytical skills.
  • Experience with Trackwise, SAP, Syncade and Microsoft Suite preferred. 
  • Ability to lead and coach staff for success
  • Strong communication skills and the capability to influence, direct change and promote learning and growth

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: R25161