GB69 (FCRS = GB069) Sandoz Ltd.

Job Summary Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable biosimilar and generic medicines. As we pursue this new and ambitious path, unique professional and personal opportunities arise, while we strive to extend low cost, high quality medicines across the globe. Key Responsibilities Lead local execution of quality systems, ensuring compliance with GxP requirements (MHRA, HPRA), global standards/SOPs and local work practices. Monitor compliance of local quality activities/systems, including metrics, quality review and self inspection. Liaise with the global quality system owner and support expert networks or Centres of Excellence. Perform risk and impact evaluations for product based decisions or the quality system and participate in escalation situations. Ensure local compliance with global standards/SOPs and maintain relevant local SOPs. Communicate requirements and changes, acting as a content expert for audits and inspections using knowledge of associated systems. Investigate, manage and actively resolve quality investigations (deviations, complaints, CAPA) with nominated third parties to minimise impact on product availability and sales. Ensure efficient information flow and effective communication of all relevant quality matters within the country organisation and between the country and the Global QA organisation. Develop and recommend changes that improve productivity and quality. Lead the implementation of quality initiatives and continuous improvements, including project planning, milestone delivery and cross functional communication. Perform tasks related to quality compliance/governance as required, such as product launch evaluations, product divestments, MAH responsibilities, regulatory updates, development of documents (site master file, business continuity plan), metrics review and quarterly leadership presentations. Provide GxP education and training to team members and cross functional colleagues. Set and review objectives using the Evolve process. Act as the responsible person defined by the UK/Ireland Health Authority, ensuring GDP operational activities are maintained, continuous improvement, compliance with MHRA/HPRA, oversight during product recalls and understanding of professional bodies such as GPhC and the Home Office. Essential Requirements 5years of experience in the pharmaceutical industry with GxP knowledge. Life science degree level or equivalent experience. Experience with line manager responsibilities. Detailed knowledge of GMDP requirements related to manufacturing, packaging, licensing, release and post market responsibilities. Development of quality systems and/or processes, with knowledge of process improvement, problem solving and evaluation techniques. Demonstrated technical and GDP knowledge and experience to fulfil duties as a responsible person. Relevant knowledge and experience concerning the distribution of medicinal products, including handling of controlled drugs. Strong interpersonal relationships and collaboration skills. Excellent communication skills to provide information at all levels. Resilience, motivation and ability to manage multiple priorities. Benefits Competitive salary and annual bonus. 24days annual leave. Flexible working arrangements. Employee recognition scheme. Learning and development opportunities. Commitment to Diversity & Inclusion We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.