Manager, Inspection and Audit
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.
The Manager, Inspection and Audit is responsible to provide overall management for Customer Audits, Regulatory Inspections and Internal Audit program at Lonza Houston.
- Manage all audit/inspection communication with external customer and internal departments.
- Serve as the main for supplier qualification program, host for Quality Audits, supervise back room and audit personnel.
- Ensure that all relevant parties are informed about potential audits and that all relevant personnel are available.
- Plan and coordinate the audits, maintain the audit calendar and provide audit forecasts to relevant parties.
- Gather and present all information requested by auditors in a timely manner.
- Ensure audit observations are responded within the given timelines and that the responses adequately address the observations.
- Maintain the audit records, assign audit reports and observations to the relevant Subject Matter Experts (SMEs).
- Review the responses provided by the SMEs and asses the suitability of responses and associated Corrective and Protective Actions (CAPAs).
- Ensure that CAPAs and observations are completed on time and that any overdue actions are escalated appropriately.
- Provide Good Manufacturing Practice (GMP) compliance oversight Audit systems.
- Establish the annual internal audit plan and internal audit report in a timely manner.
- Provide KPIs for audits and inspections
- Bachelor Degree in a related field and advanced level of experience in a cGMP environment within the Quality field.
- Preferences include Certified Quality Auditor and Lean/Six Sigma Certification.
- Display ability to incorporate rapid changes in priorities into the Audit program projects or scheduled of activities and to communicate those changes in a positive way to the stakeholders.
- Ability to communicate status, needs, forecasts, risks and timelines effectively to management. Deliver data as appropriate demand planning or staffing planning.
- Experience with regulations (US, EU and other)
- Experience in Audit and Inspection
- Experience in a biopharmaceutical manufacturing environment
- Experience in an aseptic manufacturing environment
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.