Deviation Investigations Supervisor
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 Houston’s Cell and Gene Therapy Facility is the largest in the world and our facility is growing. We are looking for professionals to grow with us and we have an exciting opportunity in our Production/Quality Assurance Team. The Deviation Investigations Supervisor will be responsible for leading at team of deviation investigators of all levels ensuring accurate, succinct and timely completion of investigations.
- Monitor team workload, provide coaching and assistance to team members as needed, and continue to grow and develop the team to meet the business needs
- Ensure resources are available to support current workload, compile Resource Model predictions, and report departmental metrics out to the leadership team
- Set goals for the team in alignment with site priorities (alongside the Senior Manager, Strategic Operations), conduct performance reviews, and ensuring the team is on track for meeting departmental goals routinely throughout the year
- Maintain positive working relationships with supporting departments, as well as customers to ensure good working relationships pertaining to deviation investigations are maintained
- Ensure adherence to cGMPs, the daily management system (DMS), standard Operating procedures (SOPs), regulatory expectations of deviations, and maintain a compliant and quality mindset at all times
- Demonstrate expertise in project management, be technical experts on deviation investigations, and have an in-depth understanding of the manufacturing process so that guidance and direction for quality investigations and overall site deviation reduction is achieved
- Coordinate multiple departments and cross functional activities through strong meeting facilitation, conflict resolution, real-time troubleshooting, and prompt decision making
- Bachelor’s Degree in Biotechnology, Biology, Chemistry, Chemical Engineering
- 4-5 years of deviation investigation experience with in the Biotech/ Biopharma production industry.
- Expert level knowledge of cGMP facilities and cGMP requirements.
- Development of leadership teams delivering progressive continuous improvement in a multi-layered organization
- Prior experience working or troubleshooting in a manufacturing environment, and technical writing experience required.
- Ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for several direct reports at any given time
- Experience communication with customer and regulatory auditors
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.