QA Manager - Raw Materials Compliance (Biotech)
Today, Lonza is a global leader in life sciences operating across five 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.
Are you prepared to become a part of a top-tier team and contribute significantly in the life sciences industry? Lonza AG is looking for a QA Manager - Raw Materials Compliance who demonstrates dedication to lead our hard-working team in New Hampshire, USA. This challenging role involves providing strategic and tactical guidance, maintaining impeccable compliance and quality standards within our rapidly expanding organization.
Key responsibilities:
- Provide strategic, tactical, and objective leadership for the Quality Raw Materials staff
- Lead a team of Quality Raw Material Specialists, ensuring value stream objectives and timelines are met
- Hire, train, and retain energized, motivated, team-oriented staff
- Maintain scheduling and training of staff, prioritize workload, and ensure delivery dates are met
- Understand regulatory requirements and Lonza policies; ensure policies and procedures are appropriate and revise as necessary
- Ensure regulatory and customer inspection readiness; represent the department in audits
- Collaborate and prioritize with QC/QA leaders and other departments
- Develop technical, GMP, and leadership skills of Quality Raw Material personnel; perform mid-year and annual reviews
- Provide general direction, support, and act as a point of escalation for staff and customers
- Ensure objectives align with customer Quality Agreements, Lonza SOPs, and regulatory requirements
- Partner with internal customers to assess and resolve higher-risk issues with Change Controls, Deviations, CAPA, and Investigations
- Manage and track Key Performance Indicating Quality Metrics; report to senior site management
- Identify and implement improvements to quality processes
- Conduct regularly scheduled one-on-one and team meetings
- Support Regulatory and Customer Audits as needed
Key requirements:
- Bachelor's degree with 5-10 years of experience or a combination of education and equivalent experience
- Proven leadership and team management skills
- Strong understanding of regulatory requirements and compliance standards
- Outstanding communication and collaboration abilities
- Demonstrated experience in quality assurance within the life sciences industry
- Ability to assess and resolve complex quality issues successfully
Join us and contribute to delivering life-changing solutions to people worldwide!
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.
