Manager, Compliance, Training & QA Document Control
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 has an opening for a Manager, Compliance, Training & QA Document Control within the Quality Assurance team in their Bend, OR location with a strong track record as a people leader who wants to bring their outstanding problem-solving skills into a fast-paced and driven environment.
- Support internal audits, client audits and regulatory inspections of assigned Quality Management Systems as the QA subject matter expert
- Maintain current knowledge of applicable regulations, guidance and standards and train personnel on cGMPs, applicable regulations
- Participate in compliance evaluation of regulated activities within pharmaceutical development and cGMP manufacturing
- Inform management of deviations from regulations and cGMP observed during review of manufacturing operations, internal audits, supplier audits, client audits, regulatory inspections; assist in determining appropriate CAPA as needed; and verify that assigned actions have been implemented and are effective
- Develop effective workflows and processes and appropriate metrics to track compliance, productivity and effectiveness
- Manage and oversee assigned 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
- Bachelor's Degree at a minimum
- 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 team player 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.