Executive Director, Global Head of Quality, Biologics

Executive Director, Global Head of Quality, Biologics

Lonza

Basel, Switzerland

We have a new opportunity at Lonza to lead the global quality network across Lonza's biologics mammalian sites. This role is responsible for all Quality aspects globally and to deliver a Quality strategy for the biologics mammalian business. The Senior Director Global Head of Quality, Mammalian Manufacturing will work in partnership with the business unit to create competitive manufacturing.

Key responsibilities:

• Providing leadership for all Quality activities related to the mammalian organization;
• Sets the strategy of the quality function for mammalian manufacturing, developing and maintaining Quality Assurance and Quality Control standards, guidelines and developing policies and procedures to ensure the quality of work in all disciplines;
• Identifies and resolves problems through stakeholders by implementing project-based solutions which deliver improved business performance against critical quality factors. Detects potential gaps and initiates corrective and preventive actions (continuous improvement);
• Responsible for promoting recognition of company quality programs among customers, as well as developing and implementing employee communication and training programs in connection with the company’s quality objectives, strategies and processes;
• Leads a team of Quality Site Heads: hiring and developing top talent to create high performing teams and succession pipelining. Ensuring active training and development plans for Quality staff with the objective of driving the overall competence and professionalism of the Quality functions;
• First contact within mammalian manufacturing for any Quality related topic. Ensures that new clients receive appropriate information regarding Lonza’s quality systems;
• Supporting the sites in the collaboration with authorities and customers which are linked to strategic growth projects.

Key requirements:

• Master’s Degree or equivalent experience ideally in Quality Management, Engineering or related science discipline;
• Significant experience in a regulated pharmaceutical industry including, manufacturing, quality assurance, quality control, R&D and/or drug regulatory affairs. Experience in biological manufacturing with demonstrated ability to interpret and implement related quality and regulatory requirements;
• Proven management experience in an EMA/FDA regulated environment, excellent working knowledge of regulatory requirements and their implementation;
• Leadership role in operations readiness including the onboarding and training of new staff – both quality and operations;
• Experience in managing Swissmedic, USFDA, EMA, MHRA Audits etc.;
• Excellent knowledge of computer systems (i.e. Microsoft Word, Excel, PowerPoint, and Visio) with demonstrated skills in the use of information management systems in a GxP environment (TrackWise, DMS, LIMS, SAP etc.);
• Effective influencing skills. Ability to communicate quality and compliance requirements to varying levels and functions of the organization. Understands the risk based approach recommended by Lonza’s planning for quality system.

Apply Now

More Job Searches

Switzerland      Clinical Research      Manager and Executive      Manufacturing and Logistics      Quality Assurance      Regulatory Affairs      Lonza