Senior Manager - External Quality Supplier Compliance - GCC

Job description

Job Purpose: The purpose of this job role is to contribute to the effective management of the supply base. This involves owning the Quality Agreements/ Product Requirement Specifications processes for Supplier and CMOs, Compliance Documents process and execution of Quality Agreements/Compliance Documents for Suppliers to support quality and regulatory compliance requirements. Key Responsibilities: • Obtaining and maintaining relevant supplier information in company systems in a systematic manner to allow for effective and efficient utilization of supplier data. Maintaining “External Auditee Records” (supplier) profiles in the relevant data systems and ensuring that Quality Agreement and Compliance Document data associated with the supplier are kept current based on currently available information as required. • Providing process ownership and KPIs oversight for Quality Agreements/ Product Requirement Specifications with Suppliers and CMOs. Initiating, negotiating, completing and maintaining Quality Agreements within scope suppliers. Escalating if necessary to stakeholders/ line manager for support with negotiations with suppliers. • Process ownership of Compliance Documents process. Collecting, reviewing and maintaining applicable compliance documentation for in scope suppliers. Examples of documentation, but not exhaustive, include: • Compliance Documentation Questionnaire • BSE/ TSE • Nitrosamine Questionnaire  • Identifying risks and communicating/ escalating/ managing per procedures to ensure management and stakeholders understand the quality risks so that appropriate mitigating actions are identified and implemented. • Obtaining and compiling relevant metrics for data analytics and trending for performance management. • Monitoring of mailbox, share point (as required) including any required logging onto applicable systems and data bases. • Responsible for providing relevant support to GSK sites undergoing regulatory/ customer inspections. Support CAPA as required. • Participate, as applicable, in the development of internal External Quality processes to ensure compliance with the GSK QMS (Quality Management System). Authoring/ revising assigned internal External Quality procedures/ guidelines. • Participate in/ lead projects or management monitoring/ internal business monitoring as required. Support and train new team members/ interns as required. • Interfaces - Routinely interfaces with Site Quality, Procurement, SQAC, R&D, wider External Quality team and GSK suppliers – a two way communication regarding supplier compliance documents, quality agreements, change control action items, etc. Required qualifications & skills: • 10+years of professional experience with Graduate/ Post graduate degree • Proficiency in and knowledge of GSK specific systems (VQMS, VQD, Power BI, etc.), preferred. • Experience in one or more areas: Production, Quality/ Regulatory, Supplier Management, Inspection Support. • Global regulatory exposure including US FDA, MHRA, and China regulations is a plus. • Good verbal and written communication skills, including ability to progress requests for information in an effective manner. • Proficient influencing and negotiating skills with internal and external stakeholders while maintaining a good relationship with them. • Ability to work in a structured and methodical manner in order to track, manage and coordinate a significant number of different requests for information at the same time with similar deadlines/ priority. • Ability and willingness to maintain rapid response to customers, staff and management. • Ability to identify, escalate and mitigate/ manage risks. • Demonstrated ability to function effectively across multiple cultures and geographic boundaries. • Strong data analytics and IT systems skills. Preferred skills: • Awareness and understanding of local and global regulatory requirements regarding subjects such as animal derived materials, residual solvents etc. • Strong command of English. Additional language skills would be an advantage. • Good time management skills to ensure assigned activities and associated documentation are completed within the required timelines. • Awareness of GSK Production System tools and techniques. Skills Data Integrity, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Risk Awareness, Supplier Auditing, Supplier Quality Management, Technical Writing    Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what mat