QA Project Manager, APR

Lonza

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. 

Our vision:

We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission:

We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
 

Do you want to help us as we shape the future of this great organization?

 

Job Description Summary

The APR Project Manager is responsible for management of the APR program for the Portsmouth facility according to ICH Q7 and other regulatory requirements such as Eudralex.  This position must be able to effectively work with all Lonza departments and applicable customers to provide technical support and expertise with the APR Program.The APR Project Manager must also be able to present the APR program to a diverse portfolio of existing clients.

Primary Responsibilities

  • Lead all activities associated with Annual Product Review (APR) process.
  • Coordinate with internal and external representatives at various levels in the creation of APR reports for commercial products manufactured at Lonza Portsmouth.
  • Work with customers and internal departments to implement an agreed project plan with milestone dates and Takt times.
  • Creation of and adherence to an annual APR schedule.
  • Perform Project Manager function by liaising with affected departments and ensuring adherence to the approved project plan.
  • Be knowledgeable of the information required to be included and be able to assist in compiling the data to support departments with competing priorities.
  • Report on progress, obstacles, and risks to Senior management and Quality Council.
  • Streamline APR process, improve adherence with regulations, ensure consistency in format and contents, and reduce cycle times. 
  • Draft new and review and edit existing SOPs for accuracy and compliance with internal procedure/policy and applicable regulations.
  • Create standardized tools for site users, including training materials
  • Train SMEs on APR requirements and regulations
  • Assist with development and maintenance of metrics or key performance indicators
  • Assist with development and refinement of the APR program
  • Act as SME for audit and inspection requests regarding APR program.
  • Work with Project Managers to ensure MSA amendments are in place.
  • Assist with projects as assigned by Management

 

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.

 

Lonza.  The place to Go, Stay and Grow.

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Confirmed 6 hours ago. Posted 30+ days ago.

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