Senior Global Quality Compliance Auditor (Biotech)
Today, Lonza is a global leader in life sciences operating across five 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.
Join Lonza AG as a Senior Global Quality Compliance Auditor and be part of a team dedicated to achieving detailed quality and compliance! This role is vital to our New Hampshire, USA location, where innovation and collaboration drive our success! As a Senior Global Quality Compliance Auditor, you will perform audits and advise sites to ensure compliance.
Key responsibilities:
Perform Supplier Quality assessments/audits of critical Suppliers and Contractors to the annual plan and follow up on agreed upon CAPAs.
Assess Suppliers' quality and ability to meet requirements using tools like Quality Risk Management (QRM), supplier assessment/audit, organizational change, and complaint/deviation trend management. This ensures uninterrupted supply of materials and services.
Act as Single Point of Contact (SPOC) for assigned suppliers from a global portfolio, representing the Head of Global Quality Compliance US.
Plan and complete corporate GMP compliance audits/assessments for medium and low risk manufacturing sites and operations as a Co-auditor.
Advise and support sites in devising and completing remediation actions to ensure compliance with regulatory and Lonza expectations.
Provide expertise on GMP compliance and standard methodologies to sites and the global organization.
Develop and maintain audit plans based on risk assessment principles, complete supplier audits/assessments, produce detailed reports, and communicate deficiencies and compliance risks.
Contribute to the reporting on QA Supplier performance, including ranking the Risk Assessment and handling critical metrics.
Key requirements:
Bachelor's degree or equivalent experience required; Master's of Science preferred.
5-10 years of validated experience in a similar role within the pharmaceutical or biotechnology industries.
Expertise in Quality Risk Management, supplier assessment/audit, and compliance risk analysis.
Strong proficiency in regulatory guidelines and quality management systems.
Outstanding attention to detail and ability to work closely within regulatory guidelines.
Proven track record to determine and successfully implement quality and compliance improvements.
Strong collaborative skills, with a dedication to contributing to an inclusive and world-class team environment.
If you are prepared to compete at a high level and make a meaningful impact, we encourage you to apply for this outstanding opportunity at Lonza AG.
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.
