Manager, Inspection and Audit Management

United States, Portsmouth (New Hampshire)

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 Inspection and Audit Management Manager provides leadership for the Inspection and Audit Management group, responsible for implementing and executing the internal audit, customer audit and regulatory inspection programs. Ensures that site management is provided current assessments of the status of the Quality System, and that compliance risks are communicated in a timely manner. Works closely with site leadership and customers to implement effective corrective and preventive actions in response to deficiencies.

Key Responsibilities

  • Leads the internal audit program. Develops the internal audit schedule, taking into account potential compliance risks. Oversees internal audits, ensuring that the audit team has the appropriate knowledge, education and experience to be able to identify significant issues through coaching and educational opportunities.
  • Leads the customer audit program:
  • Works with customers to schedule audits, ensuring that requirements defined in Quality agreements are upheld.
  • Responsible for supporting execution of and response to customer audits
  • Leads the regulatory inspection program:
  • Ensures readiness for routine GMP inspections and pre-approval inspections through an effective internal audit program and ongoing inspection preparation.
  • Ensures readiness for pre-approval inspections through close coordination with customers and internal project teams. Manages inspection logistics and communications to the site, corporate management and customers.
  • Hosts Regulatory inspections and authors/oversees responses to Regulatory bodies.
  • Works with site leadership to identify and implement remediation in a timely manner.

Key Requirements

  • Bachelor’s degree, preferably within science/life science discipline.
  • Significant management experience, preferably within a GMP (Good Manufacturing) environment in the biotechnology or biopharmaceutical industry.
  • Substantial knowledge of pharmaceutical, biotechnology industry regulations, including FDA (Food and Drug Administration), CRF (Code of Federal Regulations or others.
  • Substantial experience performing internal audits and inspections, within the biologics, biotechnology and/or pharmaceutical industry.
  • Strong organizational skills and adherence to timeframes and deadlines.
  • Able to communicate effectively and build meaningful relationships and rapport across multiple functional areas, including but not limited to, Quality, Manufacturing, Engineering, Regulatory Affairs.

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: R31050
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