Manager, Quality Assurance Validation

United States, Bend (Oregon)

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, Validation within the Quality Assurance team in their Bend, OR location. We're looking for a Manager, Validation with deep subject matter expertise and a strong track record as a people leader who wants to bring their outstanding problem-solving skills into a fast-paced and driven environment.

Key Responsibilities:

  • Manage Quality Assurance qualification and validation activities
  • Responsible for the master planning and management of the Site Validation Program as Subject Matter Expert (SME)
  • Assure that execution of protocols and validation documents is performed using controlled change management processes and procedures
  • Review and approve process validations, including equipment, cleaning, and computer systems
  • Direct involvement with client and regulatory agency audits, when required
  • Perform document generation, coordination of protocol routing and approval, and handling of discrepancy reports
  • Review and approve Installation Qualification, Operational Qualification and Performance Qualifications per Company guidelines in accordance with schedule
  • Coordinate and communicate with clients, system owners, and project management of protocol activities and status on a frequent basis
  • Lead / facilitate development of sound risk based test strategies and plans that provide adequate consideration to business and technical drivers
  • Provide discrepancy reporting and investigational support, perform data tabulations and analysis, maintain detailed protocol status and metrics and manage project timelines

Key Requirements:

  • BS in related engineering discipline or related science
  • Significant experience with a quality organization or related position in pharmaceutical/biotechnology or related industry
  • Commercial pharmaceutical manufacturing experience required
  • Prior experience as a Validation Manager or related position
  • Experience with FDA CFR Parts 11, 210, 211 and 820 quality management processes, procedures and qualification
  • GMP (Good Manufacturing Practices) experience required

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. 

Reference: R35386