Manager, QA Compliance & Validation

Lonza-posted 3 months ago
Full-time • Manager
Bend, OR
5,001-10,000 employees
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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!

  • 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 effectiveness.
  • 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.
  • 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.
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