Website Lonza
Lonza
Company : Lonza
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 Pharma & Biotech is looking for a Manager, Compliance & Validation to join the Quality Assurance team in Bend, OR. This role provides an outstanding opportunity to lead an exceptional QA team in a company that values innovation and collaboration. Join us and help drive the future of life sciences forward!
Key Responsibilities:
- Provide assistance in internal audits, audits from external parties, and regulatory inspections of designated Quality Management Systems as the QA subject matter expert.
- Maintain current knowledge of applicable regulations, mentorship, and standards, and train personnel on cGMPs and applicable regulations.
- Participate in compliance evaluation of regulated activities within pharmaceutical development and cGMP manufacturing.
- Report to management any departures from regulations and cGMP noted during the assessment of manufacturing operations, internal audits, supplier audits, external audits, and regulatory inspections. Help in identifying necessary CAPA and validate the successful execution and efficacy of assigned measures.
- Develop efficient workflows and processes, and appropriate metrics to track compliance, efficiency, and efficiency.
- Manage and supervise designated aspects of the Quality Assurance and Management System.
- Ensure procedures, systems, and processes are effective and meet regulatory requirements and business needs.
- Supervise QA staff at various levels responsible for lifecycle management of quality system documents.
- Review and approve regulatory documents.
- Perform other duties as assigned.
Key Requirements:
- Bachelor's Degree or equivalent experience required.
- Significant experience in the pharmaceutical/biotech industry.
- Compliance and Regulatory experience required.
- Prior Management experience required.
- GMP (Good Manufacturing Practices) experience preferred.
- Strong leadership, writing, and communication/presentation skills are required.
- Must be independent, self-motivated, organized, able to multi-task, and skilled in communication, facilitation, and collaboration.
- Individual must be a great teammate prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
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.