Director, Quality Assurance Compliance (Global Supplier Quality)

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Job Description

Director Global Supplier Quality Material Quality Network Oversight

Position Summary

The Director Global Supplier Quality will focus on network oversight for material quality and is responsible for providing proactive network-level Supplier Quality oversight of GMP materials across the Gilead network.

The primary purpose of this role is to anticipate and prevent material quality issues by connecting information across sites materials suppliers quality systems and emerging requirements. This role will establish global visibility to material quality signals and trends identify emerging or systemic risks and facilitate preventive actions with suppliers and internal stakeholders to mitigate issues recurrence or expansion across the network.

As a newly established role supporting the Global Supplier Quality future-state plan the Director will help define and mature Global Supplier Quality responsibilities for connecting material quality supplier capability quality risk and supply risk across the network. The role will ensure that learnings and emerging risks identified at one site are proactively evaluated for broader impact across sites material categories and approved suppliers. Through clear cross-functional interfaces governance decision rights and escalation pathways the Director will connect the dots across the network to drive proactive supplier engagement risk mitigation and continuous improvement.

Key Responsibilities

Proactive Material Quality Network Oversight

• Establish global visibility and oversight of supplier-related material quality performance risks issues and emerging trends across the network.
• Connect information across sites suppliers materials investigations defects changes inspection/testing experience and other quality signals to identify patterns and potential systemic risks.
• Proactively identify material or supplier risks that could affect multiple sites processes or products and facilitate timely cross-functional assessment and preventive action.
• Identify recurring material issues and emerging trends and ensure learnings from one site supplier or material are considered for broader network applicability.
• Develop and utilize material quality metrics trending and risk indicators to enable early identification of potential quality issues and continuous improvement opportunities.
• Support harmonization of material defect definitions and global visibility to recurring material defects.
• Provide network-level oversight and coordination for significant supplier-related material quality issues requiring cross-site assessment supplier escalation or broader organizational visibility.

Material Requirements Supplier Capability & Prevention

• Provide Supplier Quality expertise related to GMP material requirements specifications inspection/testing expectations supplier controls and material acceptance requirements.
• Partner with Material Technical Internal Quality QC Manufacturing and other subject matter experts to support appropriate alignment of material requirements to manage supplier or network quality risks.
• Provide the Supplier Quality perspective during new material introduction material lifecycle activities specification changes supplier changes compendial updates regulatory changes audit requests and other activities with potential impact to material quality.
• Apply Quality Risk Management principles to identify opportunities for preventive supplier engagement risk mitigation and continuous improvement.
• Support risk-based material qualification inspection testing and control strategies where knowledge of supplier processes controls audit history and performance is relevant.
• Identify opportunities to leverage supplier best practices or material improvements across similar materials suppliers or sites to strengthen network performance.

Supplier Escalation Governance & Cross-Functional Leadership

• Serve as a Global Supplier Quality primary contact for significant material quality issues requiring supplier engagement global visibility or cross-site coordination.
• Partner with Supplier Quality Leads and Internal Site Quality on material issues requiring formal supplier investigations CAPAs supplier performance management or improvement initiatives.
• Facilitate timely supplier engagement and escalation while ensuring material quality learnings are translated into preventive actions where appropriate.
• Provide material quality insights to Supplier Relationship Management and other supplier performance and governance forums.
• Establish effective partnerships with Internal Quality Material Technical QC Manufacturing Technical Operations Procurement/Sourcing Regulatory and other relevant stakeholders.
• Support development and continuous improvement of global governance decision rights escalation pathways and RACI for supplier-related material quality activities.
• Represent Global Supplier Quality in applicable material governance forums audits regulatory inspections and cross-functional initiatives.

Role Scope and Interfaces

This role provides the Global Supplier Quality network perspective for material quality and is not intended to replace or duplicate functional and site responsibilities. Technical ownership product and site quality decisions material specification qualification inspection disposition and other functional accountabilities remain with the designated accountable organizations in accordance with established governance and decision rights.

Qualifications

Required

• Bachelors degree in Chemistry Biology Biochemistry Engineering Pharmaceutical Sciences Materials Science or related scientific or technical discipline.
• Significant experience in pharmaceutical biotechnology or other regulated GMP manufacturing environments.
• Strong knowledge of GMP materials and material quality requirements including material specifications qualification inspection/testing supplier controls change management investigations and Quality Risk Management.
• Demonstrated experience working with external suppliers on quality issues technical/material requirements supplier performance and continuous improvement.
• Ability to analyze information across multiple sites materials and suppliers to identify trends emerging risks and systemic improvement opportunities.
• Experience leading complex cross-functional quality or technical initiatives across multiple functions or sites.
• Strong understanding of GMP quality systems and applicable regulatory requirements.
• Demonstrated ability to influence facilitate decisions and communicate effectively across technical quality operational and leadership organizations.

Preferred

• Experience with materials used in biologics parenteral and/or oral solid dose manufacturing i.e. media chemical excipients and single uses systems.
• Knowledge of compendial requirements material specifications incoming material controls sampling strategies supplier certification and risk-based testing approaches.
• Experience with supplier audits supplier risk management regulatory inspections and supplier performance management.
• Experience with enterprise material or ERP systems such as SAP and material lifecycle management systems.

The salary range for this position is: $210375.00 - $272250.00. Gilead considers a variety of factors when determining base compensation including experience qualifications and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus discretionary stock-based long-term incentives (eligibility may vary based on role) paid time off and a benefits package. Benefits include company-sponsored medical dental vision and life insurance plans*.

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Please apply via the Internal Career Opportunities portal in Workday.

Required Experience:

Director