Senior Department Manager, QA Cell & Gene Therapy
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 is 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 Senior Department Manager, QA Cell Therapy will be responsible to provide oversight to the manufacturing in the Cell and Gene Therapy contract manufacturing facility.
- Provide oversight to day-to-day Quality Assurance activities in accordance with approved SOPs / Plan / Policies for a large scale, multi-product, GMP biotech contract manufacturing facility
- Mastery and knowledge of processes is recognized by colleagues as a source of expertise
- Strategic in Quality Systems or Quality Operations planning
- Work within the Lonza Global network and establish themselves as an industry expert within both Lonza and outside
- Direct appropriate follow-up actions on any compliance issues
- Excellent knowledge and adherence to all relevant codes, standards and regulatory requirements
- Lead a team to identify problems, troubleshoot and complete or coordinate corrective action
- Participate in policy making
- Communicate quality operations and compliance perspective effectively to senior management
- Own and lead special projects, often complex in nature
- Lead the activities of a section, Quality Systems or Quality Operations
- Understand and articulate company business strategy. Maintains a broad view of the business recognizes changes and trends in the appropriate area in which the individual operates
- Mentor supervisors and senior specialists, provide input to and involve in their personnel reviews/appraisals
- Designee for QA Associate Director / Director to perform product lot dispositions, and assure that product has been manufactured and tested in accordance with cGMP requirements, company SOPs, policies and specifications
- Assign projects to staff for cost-savings
- Provide direction to staff and/or lead projects in global harmonization/ efficiency
- Any other tasks as and when assigned by Associate Director / Director.
- Extensive experience in in Validation / Quality Unit in the pharmaceutical / biotech industry
- Degree from recognized institution
- Extensive QA Operations background from the Biopharma environment
- Hands-on experience coordinating & interacting with internal departments on manufacturing activities
- Good knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility
- Good leadership skills
- Exhibit good quality decision making traits
- Meticulous and Systematic
- Analytical Mind
- Ability to define specific goals clearly, to develop and prioritize activities
- Team player, with strong focus on safety, quality and timelines.
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 achieve 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.