Headquartered in Switzerland, our client has production, R&D and business sites around the world, including Europe, North America, and Asia. Currently there are several positions available, among which the Audit and Inspection Manager.
The Compliance Manager, with his / her team members, are responsible to ensure GMP Compliance of the site. These include monitoring, trending, review, and timely closure of the Quality events, Quality Risk Management, and Supplier Management. The Compliance team supports the facility by investigating into non-product related non-conformance (deviation) and adverse product quality trends.
Delivery of services in this role will include, but not be limited to:
• Work with the Senior Manager in QA Systems to monitor Quality Performance and events of the site.
• Work with the Department Managers to ensure timely closure of all quality events such as change controls, non-conformances, investigations, corrective / preventive actions (including audit commitments), and effectiveness checks.
• Analyze and present Quality related metrics reports, data and Key Performance Indicators (KPIs).
• Randomly review into the Quality Events to ensure the Quality Events are completed to the level as required.
• Develop strategies for Quality Risk Management and Continuous Improvement. Maintain a system for managing, handling, and evaluating Quality Risks.
• Acquire and maintain knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on Quality Compliance Matters is provided to the site.
• Assess and evaluate new Lonza Global Quality Standards, and implement locally where appropriate.
• Participate in the internal audit programs as internal auditor, when required.
• Manage and maintain a system for handling, evaluating, and reporting customer complaints.
• Manage and maintain a system for Annual Product Review / Product Quality Review with the Customers, when required.
People Development / Communication:
• Coach and develop team members on the new local and international regulatory and legislative requirements, and to interpret and implement locally.
• Communicate potential quality risks / issues based on trends / observations to the senior management team via mechanism such as Quality Council and / or management meetings.
Continuous Compliance Improvement:
• Support in the Development and maintenance of Department Policies, SOPs, and other documents to ensure compliance to Lonza Global Quality Standards.
• Work with team members and department managers to evaluate and identify gaps on regulatory guidelines.
• Identify improvement opportunities in the Quality Compliance related areas.
• Perform the improvement related activities when required.
• Interpersonal skills, including leadership, coaching and development, performance management, motivation, communications and negotiations.
• Must have GMP, Quality, and Risk Management knowledge.
• Compliance knowledge of regulations in multiple GMP area(s); ability to translate regulations into operational requirements (21 CFR 210, 211, 600s, 1271, as well as Eudralex Volume 4 Part 4 for ATMP Manufacture).
• Experience in site based manufacturing or quality operations in managerial roles.
• Ability to investigate, recognize and diagnose trends and patterns.
• Action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, and analytical thinking.
• Knowledge of Cell and Gene Therapy Products and Processes.
Robin Bisschof +31 43 326 08 00
Robin Bisschof +31 43 326 08 00