Early Phase Quality Assurance Manager

United States, Bend (Oregon)

Responsible for building, maintaining and sustaining phase appropriate key quality functions for Early Phase pharmaceutical production including development, pre-clinical and clinical activities in a CRO/CDMO environment.  Develops staff in key quality systems and regulatory guidelines.  Escalates issues to the quality management and other Site leadership that could pose any compliance risks to the site.  Ensures R&D, product development and clinical procedures, equipment, facilities, people adequately meet regulatory requirements and are audit ready.   

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 Early Phase Quality Assurance Manager at our Bend, OR location. As an Early Phase Quality Assurance Manager, you will be responsible for building, maintaining and sustaining phase appropriate key quality functions for Early Phase pharmaceutical production including development, pre-clinical and clinical activities in a CRO/CDMO environment. 

Key responsibilities:

  • Exhibits technical depth in organizational management, cGMP quality systems, US and non-US cGMP regulations and FDA, EU and ICH guidelines with practical implications and applications for an early phase clinical setting
  • Able to architect and implement new phase appropriate cGMP systems (policy, procedures, work instructions etc.) to support early phase clinical offering
  • Demonstrates record of successful interaction with regulatory agencies, internal and external auditing groups, and preparation of all required correspondence
  • Demonstrates experience with clinical cGMP facilities, processing equipment, laboratory testing, manufacturing, and understanding of the technical, regulatory, development and commercial aspects of pharmaceutical products
  • Develops staff in key quality systems and regulatory guidelines
  • Escalates issues to the quality management and other Site leadership that could pose any compliance risks to the site
  • Ensures R&D, product development and clinical procedures, equipment, facilities, people adequately meet regulatory requirements and are audit ready
  • Provides guidance to the QA (Quality Assurance) team in the development, implementation and management of quality systems
  • Approves Certificate of Compliance for early phase products
  • Assures a steady flow of QA approval of early phase products
  • Works with internal and external customers, US and non-US regulatory agencies and partners on quality and compliance issues
  • Advises management on potential issues, and ensuring the implementation of the appropriate actions

Key requirements:

  • Bachelors degree
  • Pharmaceutical/Biotechnology or related FDA (Federal Drug Administration) regulated industry experience is required
  • Quality Assurance Management Experience preferred
  • Experience as a CRO (contract research organization)/CDMO (contract development and manufacturing organization) organization or closely interacting with a CRO/CDMO preferred

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: R23585