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Executive Director of Quality Management

vor 2 Monaten


Basel, Basel-Stadt, Schweiz Lonza Vollzeit
About the Role

We are seeking a highly experienced and skilled professional to join our team as a Global Head of Quality Operations. This is a key leadership role that will be responsible for providing technical Quality/Regulatory-related expertise and Quality Operational Management oversight to our Biologics site network.

Key Responsibilities
  • Provide leadership for Quality and Regulatory activities across the Biologics network, ensuring alignment with customer needs and linkage with the overall Quality and business unit strategies.

  • Plan, direct, and control all quality requirements, leading a team of DPS Quality Site Heads and ensuring active training and development plans for Quality staff.

  • Identify and resolve problems by implementing project-based solutions, delivering improved business performance against critical quality factors, and detecting potential gaps and initiating corrective and preventive actions.

  • Oversee the training of overall quality specifications and standards, working towards a quality-oriented culture across the organization, and ensuring site alignment with all recognized local and international standards.

  • Provide expertise and coaching to Biologics sites and their teams for harmonized implementation of Quality policies, procedures, and specifications, and contribute to the development and maintenance of global and local quality systems in line with current regulatory requirements.

  • Support the transition from traditional QA compliance practices towards new frameworks for the regulatory oversight of manufacturing quality, and closely follow industry trends and engage in industry associations to develop innovative future manufacturing concepts.

  • Active member of the Lonza Biologics Quality Leadership Team (BQLT) and the DPS BULT, with a strong understanding of cGxP regulations and regulatory trends as they pertain to the stated responsibilities.

Requirements
  • Master's Degree or equivalent experience in Quality Management or a related science discipline.

  • Relevant experience in a regulated pharmaceutical industry, including manufacturing, quality assurance, quality control, R&D, and/or drug regulatory affairs.

  • Experience of chemical and biological GMP API manufacturing with demonstrated ability to interpret and implement related quality and regulatory requirements in a cGMP environment.

  • Proven management experience in an EMA/FDA regulated environment, with an excellent working knowledge of current ICH, PIC/S, EU, and US 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, and hosting and managing inspections and audits.

  • Excellent knowledge of computer systems, including Microsoft Word, Excel, PowerPoint, and Visio, with demonstrated skills in the use of information management systems in a GxP environment.

  • Working knowledge of modern approaches to compliance, such as cGMP in the 21st century, and modern quality tools, such as risk-based approaches – FMEA, statistical process control, design of experiments, and Six Sigma.

  • Strong verbal and written communication skills, with the ability to communicate quality and compliance requirements to varying levels and functions of the organization.

  • Proven ability to lead, mentor, and coach direct reports and teams with or without direct line responsibility.

  • Strong organizational skills, with the ability to balance multiple priorities simultaneously.

  • Ability to solve problems, detail-oriented, understands the strategic picture, provides practical solutions, and strong analytical and investigative skills.