Conformance Specialist

Requirements

• Relevant qualifications (eg; HND or 'A' levels in scientific, technical engineering discipline) and / or equivalent experience (ideally gained working in a Pharmaceutical Manufacturing Facility or similar highly regulated industry).
• Experience of managing regulatory compliance or regulatory affair-processes related activities within a pharma or consumer supply chain environment.
• Knowledge of current Good Manufacturing Practice (cGMP) requirements.
• Experience obtained working in highly regulated industry, including knowledge and application of the principle of the Quality Management Systems (QMS).
• Experience in regulatory affairs, particularly post-approval licence maintenance and variation submissions, would be preferred but is not compulsory.

Benefits

Additional Information

443493 The Quality function promotes quality and compliance through the product life-cycle in the manufacturing and production operations across GSK Sites. The team supervises all Regulatory compliance related systems, improvement procedures and documentation (including analytical data and information) to ensure products released have been manufactured and packaged according to all Regulatory and cGMP requirements (including appropriate certification for the UK/EU markets). Job Purpose: As Conformance Specialist you will develop and provide input to regulatory strategies, change control and compliance issues for the manufacture and registration of established API (Active Pharmaceutical Ingredients), Finished Products and New Product Introductions (NPIs). The role ensures site compliance by the interpretation of corporate standards (e.g. the QMS), pharmacopoeial requirements, regulatory authority directives, license renewals/annual reports and commitments made to regulatory authorities. You will support the Quality Assurance department and all manufacturing units across the site by handling compliance to all licences in all markets supplied (directly or via a packaging site). Key Responsibilities (include..): Act as product regulatory specialist for the site: Provide product regulatory advice for the impact of all changes made on site (e.g. Reg Advice 1) ensuring regulatory compliance in all markets Maintain product quality specifications to ensure manufacturing and release and end of life testing complies with registered details and pharmacopoeial requirements. Provide and approve regulatory information for periodic product reviews Lead NPI submissions and reviews working with site SMEs and central/local functions to meet GSK submission & launch dates and without undue regulatory restriction on company operations. Ensure robust evaluation of registered detail that will be submitted to allow future operational flexibility and ensure compliance. Act as the primary site contact with central regulatory groups (pre and post approval) and Local Operating Companies (LOCs), making decisions on behalf of the site: Develop regulatory strategies using innovative thinking to support site and business strategies/priorities (NPI & existing products - line extensions), approving plans for wave 3 launches Review and approve all regulatory documents (submissions, variation dossiers, licence renewals, response to questions and annual reports) to meet GSK submission & launch dates and without undue regulatory restriction on company operations. Support regulatory compliance on site: Internal and external audits Regulatory/Pharmacopoeial Intelligence Provide support to maintain statutory Site licenses. Lead or assist with quality and compliance-related deviations. Environment, Health and Safety (EHS) requirements About You: As this role is multi-faceted and includes liaising with a wide variety of on-site production and operations teams, you will be a self-motivated person who has experience of working in regulatory, quality and/or manufacturing at a complex manufacturing site. You will be resilient and calm under pressure, with strong people skills. You will have a strong continuous improvement mindset. Effective written and verbal communication and excellent interpersonal skills, as well as the ability to organise and prioritise workload are considered essential skills. About Ware Manufacturing Site: Medicines at Ware are presented as either Respiratory devices or in Oral Solid Dose form, and the site has circa 1,500 highly motivated and capable people working at it. The Ware site holds a unique position in our network as the site responsible for launching the company's pipeline of new medicines in oral and solid dose forms, as well as operating a high-volume commercial production for respiratory devices. CLOSING DATE for applications: Wednesday 8th of July 2026 (COB).

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