Job Description : - The purpose of this role is to ensure that suppliers of Active Pharmaceutical Ingredients, production materials provider assigned to the individual meet GSK requirements and to complement business initiatives currently being or planned to be implemented within GMS. the Zero Defects ambition for GSK, by proactively working with suppliers improvement plans are in place and on track. This role involves interface with the supply base but also provides an inward facing- contact with designated GSK site(s) to ensure effective management of supplier - This role is the point of contact for supplier related quality issues for the Procurement Commodity teams. Job Description : Strategy : Provide QA input into production procurement sourcing strategies. - Provide QA input into new product supply strategies as they relate to supplied materials and services. Risk management : - Carry out investigations into significant quality incidents (e.g. escalated complaints) arising at suppliers and ensure root cause of the problem is identified and appropriate corrective and preventative actions are implemented. - Communicate results of investigations and/or identified risks to ensure stakeholders understand the technical, regulatory and quality risks. - Ensure any learnings from incidents are communicated across GSK and to relevant suppliers. - Develop the Quality Risk Model for nominated suppliers and use the output to identify low control suppliers and engage stakeholders. Supplier quality management and improvement : - Maintain an awareness of supplier's quality performance and material / component defect levels. Provide such information to other audit teams as part of assessment preparation when required. - Identify areas for improvement across the supply base, including risk model output, and ensure these are incorporated into suppliers- quality improvement plans. - Provide assistance, technical advice, training and workshops to suppliers to achieve compliance with the audit standards. - Manage process and analytical changes with designated suppliers, ensuring appropriate review with technical and user sites. Ensuring any required validation and regulatory work is completed to the required standard. - Provide support for new product introduction validation and PAI readiness activities. - Manage supplier related change controls and deviations, as required. Regulatory inspections at GSK sites and Suppliers : - Ensure relevant support is available to GSK sites undergoing regulatory inspections. - Provide an appropriate level of support for strategic suppliers undergoing regulatory inspections. Internal supplier quality processes : Work in alignment with the internal supplier quality processes and championing improvements in ways of working where applicable. Interfaces : - Participates in relevant external bodies to help establish and influence the GSK position on quality matters relating to production suppliers. - Works with GSK sites, Supplier Quality Audit & Compliance, and Procurement teams to establish and implement a robust supplier quality improvement program. Responsible for communicating effectively to internal stakeholders on improvement activities. - Work with the business to facilitate acceptance of materials and components on the certificate of analysis to undertake the necessary activities to maintain a compliant status in respect of these activities. Minimum Level of Education : - Science degree or experience in pharmaceutical manufacturing and quality operations. - Trained in OE tools and techniques to at least green belt standard. - Good knowledge of regulatory and GSK quality requirements and ability to explain these and relate to GMS and supplier operations and apply good business judgment in doing so. Area of Specialisation : Relevant Science (Biology, Chemistry, Pharmacy) or Engineering Degree Why is this Level of Education Required : - Enable reasonable understanding of the production processes to be an effective manager and being able to support staff in their development Minimum Level of Job-Related Experience required : - Knowledge of regulatory, GMP and GSK quality requirements and ability to explain these and relate to GMS and supplier operations, applying good business judgment in doing so. - Extensive knowledge of technologies used within the material / component supply base. - Awareness and understanding of business environment and ability to build networks with third party suppliers. - Good influencing and negotiating skills to ensure implementation of appropriate standards, specifications, and agreements and to persuade internal and external stakeholders to buy into a specific course of action. - Good verbal and written communications skills to ensure effective relay of issues, risks and opportunities so that these are well understood by all parties and that effective actions are put in place. - Demonstrated ability to function effectively in a matrix organization, across multiple and geographic boundaries. - Experience of pharmaceutical operations, and regulatory requirements. Operational Excellence skills : Possessing a range of tools and techniques needed to drive continuous and step change improvement in operations.

Gurgaon/Gurugram

GlaxoSmithKline - Supplier Quality Operations Manager 

GlaxoSmithKline - Supplier Quality Operations Manager  ,Job Description for GlaxoSmithKline - Supplier Quality Operations Manager  in GSK in  Gurgaon/Gurugram for (12-15) years of experience. Apply Now!

Job Description for GlaxoSmithKline - Supplier Quality Operations Manager  in GSK in  Gurgaon/Gurugram for (12-15) years of experience. Apply Now!