Associate Director - External Quality Supplier Compliance - GCC

Job Purpose:

The purpose of this job role is to provide leadership and direction of External Quality Supplier Compliance governance, processes, data, to ensure timely availability of business critical and regulatory compliance information.

This job role provides the global directional and management oversight of the External Quality Supplier Compliance team, ensuring that Quality Agreements/ Product Requirement Specifications processes for Supplier and CMOs, Compliance Documents process and execution of Quality Agreements/ Compliance Documents for Suppliers are in place, compliant, adequate and carried out in accordance with GSK standards and procedures by appropriately trained and capable staff.

The role interfaces with the SQ A&C and wider External Quality teams, GSK Sites, Procurement, R&D and global supply base within scope. The role would also be the contact point for equivalent organizations in R&D.

Key Responsibilities:

Supplier Compliance

• Responsible for management of the execution of supplier Quality Agreements, Compliance Documents.

• Responsible for building team’s capability and supporting initial engagements with suppliers and sites.

• Responsible for ensuring that supplier data in relevant GSK systems remains accurate and current based on available information.

• Responsible for ensuring adequate support for team on escalations/ issues faced e.g. negotiations with suppliers on Quality Agreements.

External Quality governance and processes

• Responsible for governance and oversight of processes, KPI targets and IPT strategy for compliance and performance delivery.

• Responsible for ensuring that GSK systems and platforms such as Veeva Docs, Veeva QMS, team mailbox, share point are supported and available. Integration of new business technologies and systems, including roll out and training.

• Responsible for ensuring that appropriate External Quality processes and procedures are in place and meet the requirements of the GSK Quality Management System, as appropriate.

• Responsible for data and analytics such as metrics and risk management.

• Responsible for ensuring that training is current for self as well as all staff within the team.

• Responsible for ensuring appropriate change control actions, CAPAs are supported.

• Participate in/ lead projects or management monitoring/ internal business monitoring as required.

Risk management

• Responsible for ensuring that identified risks are communicated/escalated to ensure management and stakeholders understand the technical, regulatory and quality risks and that appropriate mitigating actions are identified.

• Responsible for ensuring any learnings from audits, investigations, incidents, etc. are communicated across team and GSK, as applicable.

• Responsible for ensuring team is represented and providing needed input into applicable stakeholder Quality Councils.

Regulatory/ Customer Inspection support

• Responsible for ensuring adequate related support is provided to user sites for regulatory inspections. Lead/ support CAPA as required.

Interfaces

• Routinely interfaces with Site Quality, Procurement, wider External Quality, SQ A&C, R&D, GSK suppliers – Providing a two way communication regarding supplier information, risks, alignment of processes and support. 

Team Management

• Responsible for human resource management and personnel management including performance management and professional development within team.

• Responsible for setting the proper quality culture within the team.

• Responsible to recruit, manage and develop staff based in strategic locations.

• Drive the realization of activities in line with given budgets and KPIs.

Required qualifications & skills:

• 15+years of professional experience with Graduate/ Post graduate degree

• Proficiency in and knowledge of GMP regulatory and GSK quality requirements and ability to explain these and relate them to GSK and supplier operations, applying good business judgment in doing so.

• Strong global regulatory exposure including US FDA, MHRA, and China regulations.

• Awareness and understanding of the business environment and ability to build networks and relationships with third party suppliers, external professional organizations and internal stakeholders.

• Reliable influencing and negotiating skills to ensure implementation of appropriate standards and agreements with GSK user sites, suppliers and other internal stakeholders as well as to facilitate internal and external stakeholders in reaching agreement to a specific course of action to mitigate known risks.

• Good verbal and written communications skills to ensure effective relay of issues, risks, objectives and opportunities both vertically and horizontally through the organization so that these are well understood by all parties and that effective action plans are put in place.

• Demonstrated leadership ability and experience leading, managing and motivating remotely based professional staff across multiple cultural and geographical boundaries.

• Demonstrated ability to function effectively in a matrix organization, across multiple cultural and geographical boundaries.

• Demonstrated ability to execute business strategies by translating these into workable business processes.

• Ability to deal with complexity and lead business solutions.

• Good strategic and tactical thinking.

Preferred Qualifications

• 7+ years of relevant experience in pharmaceutical or consumer healthcare manufacturing, quality operations, or supplier quality management.

• Experience with Operational Excellence / Lean / GSK Production System tools (Green Belt preferred).

• Strong multicultural awareness with experience working across global supply chains.

• Ability to manage complexity, competing priorities, and high‑risk situations with confidence.

• High organizational awareness and strategic problem‑solving capability.

• Knowledge of global GMP expectations, supplier technologies, and impact of non‑conforming supplies.

• Experience identifying emerging trends in compliance, assurance, and risk management

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 matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.

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