Senior Quality Manager

Senior Quality Manager

Galderma

London, United Kingdom

In this essential position, you will lead ongoing enhancement and change management efforts within the Galderma UK & Ireland organisation. You will offer specialised assistance to develop, manage and strengthen the quality management system, support both global and local business process leaders, and ensure adherence to regulatory and organisational standards.

Key Responsibilities:

• Act as Responsible Person named on the site’s WDA;
• 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;
• Implement and maintain the QMS to ensure required processes are established and effective;
• Actively contribute in management of quality systems such as, but not limited to; internal audits/self-inspection, change control, management reviews, deviation management and CAPA;
• Compile and update training manuals, undertake induction training and refresher training related to QMS for Galderma staff;
• Support quality agreements establishment with Galderma third parties;
• Support Galderma to ensure third parties are qualified and maintained in an approved audit status;
• Ensure product samples are authorised with maintained traceability and product integrity;
• Provide disposition decision for returned and damaged products;
• Authorise the movement of any product from quarantine to available product status;
• Maintain and report of Quality KPIs;
• Support local repackaging of non-medicinal products to be performed in accordance with specifications and required licenses;
• Develop and manage effective relationship with competent authority and Galderma Global teams;
• Foster and maintain good cross-functional relationship with other departments; attend cross-functional meetings and represent the local operating site where necessary;
• Represent Galderma in the relevant committees of the professional/industry associations, if necessary.

Knowledge & Skills:

• Thorough knowledge of medical device and medicinal products and the country/regional regulations and governmental authorities;
• Ability to take decision and give instruction to all employees to in his/her field of activities to ensure compliance with legal requirements;
• Capability for sound GxP related decisions;
• Able to read, write and speak English fluently;
• Good understanding of the commercial drivers of the life science industry and an associated ability to provide advice/guidance that takes these into consideration;
• Good, positive and proactive communication and the ability to foster excellent working relations with external customers including the health authorities, industry associations and internal stakeholders;
• Skills such as project management, problem solving, ability to present information in easily understood format at internal and external meetings, good time management, negotiation, and interpersonal skills;
• Be proactive, motivated and a self-starter;
• Be able to balance company commercial needs with achieved compliance;
• Ability to think strategically and innovatively for resolution of quality issues;
• Commitment to continued improvement in department processes and performance;
• Strong team player, assisting others with workload peaks and the management of challenging situations;
• Proactively contribute to a positive team attitude and highly productive work environment;
• Ability to influence others;
• Excellent Excel, PowerPoint and Word skills.

Education & Professional Experience

• Bachelor of Science Degree in Pharmacy or Life Science;
• Registered and in good standing with the MHRA as a Responsible Person (RP) for wholesale distribution activities;
• 5-7 years’ experience in the bio/pharma industry, preferably;
• acquired in Quality Assurance departments;
• nice to have : Experience in prescription- and OTC pharmaceutical OR medical devices products.