Manager, QA Compliance & Validation
About The Position
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. Lonza Pharma & Biotech is looking for a Manager, QA Compliance & Validation to join our Quality Assurance team in Bend, OR. This is an exciting opportunity to lead a high-performing QA team and ensure compliance across pharmaceutical development and manufacturing. Your work will help shape processes that improve lives worldwide. What you will get An agile career and dynamic working culture. An inclusive and ethical workplace. Competitive compensation programs that recognize high performance. Medical, dental, and vision insurance. Access to global benefits: https://www.lonza.com/careers/benefits. 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.
Requirements
- Bachelor's degree or equivalent experience.
- Significant experience in the pharmaceutical or biotech industry.
- Strong compliance and regulatory knowledge.
- Prior management experience with leadership skills.
- Familiarity with GMP (Good Manufacturing Practices) preferred.
- Excellent communication and collaboration skills.
- Ability to work independently and as part of a team.
Responsibilities
- Support internal and external audits and regulatory inspections as a QA expert.
- Train staff on cGMP and regulatory standards.
- Oversee compliance evaluations for development and manufacturing activities.
- Identify and validate corrective and preventive actions (CAPA).
- Develop workflows and compliance metrics to improve efficiency.
- Supervise QA staff and manage quality systems documentation.
- Review and approve regulatory documents.
Benefits
- An agile career and dynamic working culture.
- An inclusive and ethical workplace.
- Competitive compensation programs that recognize high performance.
- Medical, dental, and vision insurance.
- Access to global benefits: https://www.lonza.com/careers/benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Industry
Professional, Scientific, and Technical Services
Number of Employees
5,001-10,000 employees
