Head of Quality, UK & Ireland

Head of Quality, UK & Ireland

Galderma

London, United Kingdom

Job Description

The Head of Quality UK & Ireland will be responsible for the direct supervision of the company concerning all activities covered by the MHRA Establishment license and HPRA rules. Lead and manage activities related to Quality Assurance in UK & IRL. Maintain the local Quality Management System and monitor its compliance status. Contribute proactively as an effective leader, functioning responsibly and autonomously while working within the framework of internal and external regulatory guidelines and procedures.

Key Responsibilities

• Implement Business Development plans and support business development activities of the organisation, including growing and supporting franchise operations in line with business and financial objectives;
• Process owner of quality systems such as, but not limited to; internal audits/self-inspection, change control, management reviews, deviation management and CAPA;
• Implementing and maintaining the QMS to ensure that required processes are established and effective;
• Lead and perform Quality and compliance specific tasks including but not limited to processing product complaints, review of information about secondary packaging/redressing, ensure proper labelling of products at the distributor, and product recall coordination;
• Manage the creation/update of local SOPs to reflect local practices in accordance with Corporate Policies and SOPs;
• Ensure Galderma UK third parties are qualified and maintained in an approved audit status;
• Leadership, teamwork, and collaboration;
• Develop and manage effective working relationships with competent authority and Galderma Global teams;
• Compile and update training manuals, undertake induction training and refresher training related to QMS and regulatory requirements for Galderma UK staff;
• Represent the company in the relevant committees of the professional/industry associations, if necessary.

Skills & Qualifications

• Bachelor’s degree in Pharmacy or Life Science;
• Proven experience in the bio/pharma industry, preferably acquired in Regulatory Affairs or Quality Assurance departments;
• Experience in cosmetics, prescription and OTC pharmaceutical, and medical devices products;
• Management experience;
• Ability to balance risks with compliance in a regulated environment.

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