QA Project Manager - US02 Lonza Biologics Inc.

Today, Lonza is a global leader in life sciences operating across three continents. 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 is building a large scale dedicated facility to allogenic product for a key customer. The QA Project Manager is responsible supporting and managing operational QA aspects of the dedicated manufacturing facility.  Accountable to manage operational QA projects need to be executed  during the construction, and process fit out of the dedicated facility.  Develop the project scope, define project guidelines, obtain cross-functional sponsor approvals where needed, and coordinate the resources necessary to successfully complete the project.

Key Responsibilities:

• This position is responsible for the internal running of QA projects for dedicated facility.   Accountable for project initiation, planning and for oversight of project execution, implementation and closeout
• Develop the project scope, define project guidelines, obtain cross-functional sponsor approvals where needed, and coordinate the resources necessary to successfully complete the project
• Identify potential project risks, and conduct regular status meetings to review project activities, address project challenges and recognize project successes. Communicate major milestones as directed by the Head Quality Assurance Operations
• Responsible for the generation and issue of meeting minutes from any project meeting
• Manage internal conflicting resource demands with the objective of keeping the project on track
• Supply feedback on internal project team members to their supervisor to allow for development, or reinforce positive behaviors

Key Requirements:

• Bachelor's in Life Sciences or related field  required
• 5+ years of experience in a regulated/ compliant pharmaceutical or biotechnology production environment; aseptic experience preferred
• Thorough knowledge of cGMPs required.
• Strong analytical and problem solving skills coupled with the ability to work both independently and in a team environment
• Experience with method validation and technology transfer
• Proficient in the use of spreadsheets, databases, and word processing software
• Ability to perform statistical analysis of data
• Knowledge of LIMS, SAP and TrackWise systems a plus
• Experience with implementation of new QC Equipment preferred
• Exposure to Six Sigma methodologies and concepts, including process improvements / efficiency projects a plus

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.