Head of Quality Operations

United States, Hayward (California)

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.

The Head of Quality Assurance Operations will oversee all aspects of quality assurance for the Lonza Hayward manufacturing facility, ensuring that the quality systems and controls meet Lonza global standards and regulatory requirements.  The individual who fills this role must be a strong partner with the Manufacturing Operations teams and other teams that support operations (QC, MSAT, FAC, ENG, VAL and QS).  The QA Operations Head must also be a strong partner with clients to ensure that project and delivery timelines and expectations for product quality and GMP compliance are met.  Prior experience in biologics manufacturing is desired, but not essential.  A strong foundation in application of GMPs in a drug substance manufacturing environment is critical, as is an ability to quickly assess facts and make the appropriate decision when process/product quality may be impacted.

Key Responsibilities:

  • Develops and implements the overall quality strategy for the facility. 
  • Partners with the Site Director, Head of Quality and Senior Leadership Team to ensure alignment with Manufacturing and support functions in executing the strategy. 
  • Acts as the lead SME for significant quality or compliance issues within the facility. 
  • Manages QA Ops budget and resources to maximize efficiency and maintain quality/compliance at high levels.
  • Develops, directs, and maintains quality systems in support of manufacturing in a manner consistent with global quality systems, Lonza Corporate requirements and standards and current regulatory requirements, (primarily US FDA and European requirements) and others as needed.  Quality systems include but are not limited to audits and inspections, documentation and records management. 
  • Interfaces with site QA functions to support or develop appropriate interfaces with the site-based QA systems. 
  •  Develop working relationships with other site functions for support of equipment, facility, utility, cleaning services and computer validation/qualification.
  • Oversees all aspects of QA operations within the facility, including but not limited to executed batch record review, on the floor QA support, raw material release, deviation investigations, change controls, Quality Agreements, customer quality support and SOP and master batch record review. 
  • Responsible for release of bulk drug substance batches.
  • Ensures QA support for internal and external project and team meetings. 
  • Interfaces with customers and internal groups for resolution of quality issues. 
  • Has decision-making authority for any Quality issues; informs Site Quality Head of critical issues in a timely manner.
  • Builds and maintains expertise in the QA Ops teams, including development of staff. 
  • Applies biologics manufacturing experience to ensure that operations meet customer and regulatory expectations and requirements for manufacturing at all phases of product development.

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: R39307