Senior Quality Assurance Project Manager, Bioscience
United States, Walkersville (Maryland)
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.
Lonza Walkersville is actively seeking a Senior Quality Assurance Project Manager to join our team! This individual will be responsible for providing Quality and Compliance oversight to all activities specific to Bioscience Research and Technology (R&T) related projects. A wide degree of creativity and latitude is necessary. Individual should be able to work independently with little direction. The individual provides guidance and reviews documentation supporting Bioscience R&T projects including technical transfer documentation. No direct reports are expected; however, the individual may manage the status of cross-functional team members regarding the quality aspects of a project.
- Verification of R&T project design, planning and execution of R&T projects to ensure compliance with current ISO/cGMP requirements. Provide oversight for compliance of validation master plan, design documentation, technical transfer requirements and review of final reports.
- Provide immediate support to Operations and Quality Control staff to address compliance related concerns with regard to specific projects as they transition from Research to Operations. Act as Quality Assurance (QA) representative on cross-functional teams, including conference calls, meetings and other standard means of communication.
- Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams. May need to lead and direct the work of others both cross-functionally and within QA.
- Audit internal quality system elements of research and development projects to ensure technical transfer to manufacturing and operational support areas is completed on time and in compliance with international cGMP regulations.
- Collaborate with internal QA management and team members to ensure alignment with current site SOP, policies and procedures. Maintain sense of urgency to manage QA aspects of project to ensure timelines are met.
- Bachelor’s degree in life sciences required. Master degree or PhD preferred. Preferred area of study: Life Sciences
- Substantial GMP related experience in the biologics or related industry, with significant direct QA experience.
- Working knowledge of cell culture, cell culture starting materials and aseptic processing experience required, or an equivalent amount of aseptic processing, cell therapy or cell culture manufacturing experience
- GMP compliance knowledge including knowledge of 21CFR210, 211, 610 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing; ISO 9001:2015, 13485 and Part 11 compliance knowledge preferred.
- Working knowledge of principles and practices of aseptic processing and the associated international aseptic processing regulations. Working knowledge of endotoxin testing required.
- Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic.
- The ability to interface and communicate directly with clients may be required. Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.
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.