Head Quality

Lonza

Ploermel, France

As the Head of Quality you are the leading source of Quality/Regulatory-related expertise within the Ploermel organization and is responsible for providing the strategic leadership and management of the site’s Quality organization.

The role is tasked with developing and executing the site’s Quality strategy commensurate with the overall plan for the company. Ensure alignment with customer needs and linkage with the overall Quality and business units strategies.

You will develop, implement and monitor Quality programs, policies and procedures to ensure compliance with GMP standards, corporate policies, and global regulatory guidelines.

You will serve as the point of contact for client partners regarding product quality matters, customer satisfaction levels and regulatory authority interaction.

Key responsibilities:

  • Provide leadership to the Ploermel Quality organization to ensure that teamwork, high morale and innovation are fundamental components of a world-class team;
  • Implement continuous improvement initiatives to drive Quality programs and ensure maximum productivity. Ensure systems meet the needs of all internal and external constituencies with an emphasis on quality, compliance, product safety, process, productivity, budget control, and profitability;
  • Install and lead quality organization (QA, QC) at site. Provide expert quality related support to the site quality and manufacturing units;
  • Serve as the site Quality expert, providing solid, well-informed, actionable Quality support to Ploermel Operations, Product Development, R&D, and other functions, as requested;
  • Oversee the development of a risk assessment strategy reflective of the Lonza Quality and Compliance philosophy and approach to assessing and managing risk. Manage the effective and diligent execution of that strategy;
  • Member of Ploermel site leadership team;
  • Perform other duties as assigned.

Key requirements:

  • extensive experience in Pharmaceutical Quality and/or CMO Industry;
  • significant years in a management role;
  • strong knowledge of current industry trends and has the ability to use the latest technologies;
  • Expert knowledge of cGMP’s, including EU and US regulatory requirements applicable to pharmaceutical products.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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