Manager, QA Compliance & Validation

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.

• 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.

• 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.

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.