Manager, Quality Assurance Compliance

Biopharma Careers; Foster City (CA); On-site; USD 136,000 - 176,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Bonus eligibility

Stock-based incentives

Job summary

Gilead Sciences Inc. seeks a Manager/Sr. Manager, Global Supplier Quality to lead supplier quality activities across the enterprise.

You will drive compliance, data integrity, and lifecycle stewardship for supplier notifications, master data, and the Approved Supplier List. Collaboration with cross-functional teams is essential to maintain product quality and regulatory compliance. The role requires 4+ years in QA/Supplier Quality in pharma, familiarity with GMP/GDP, and experience with systems

Qualifications

• Strong analytical and critical-thinking skills with ability to assess supplier quality impacts.
• Cross-functional collaboration, communication, and relationship-building abilities.
• Experience with supplier quality systems and data management concepts.
• Understanding of GMP, GDP, ICH, FDA/EMA requirements and data integrity.

Responsibilities

• Manage the SNA lifecycle from intake to closure with risk-based evaluation.
• Triage supplier notifications and assess impact to determine required actions.
• Maintain SNA records ensuring timelines and quality requirements.
• Coordinate cross-functional assessments and track actions through completion.
• Communicate with suppliers to obtain information and supporting documents.
• Summarize impact outcomes and support stakeholder decisions.
• Ensure supplier changes do not impact product quality or patient safety.
• Drive improvements in visibility, governance, and change-management processes.
• Analyze quality metrics and report trends related to supplier notifications.

Skills

Analytical skills

Critical thinking

Cross-functional collaboration

Communication

Data integrity

Tools

Veeva

SAP

GPLM

Job description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Manager / Sr. Manager, Global Supplier Quality

Position Summary

The Manager, Global Supplier Quality is a critical role in maintaining supplier quality compliance, ensuring accurate supplier data, and supporting the operations, effectiveness and improvement of the supplier management lifecycle, supplier notification assessment process, supplier quality master data management, and proactive maintenance of the approved supplier list. This role drives compliance, risk-based decision-making, and data integrity across supplier-related processes while supporting cross-functional alignment and continuous improvement initiatives within Gilead’s Quality Management System (QMS).

Key Responsibilities

Supplier Notification Assessment (SNA) Management and Coordination

• Manage the Supplier Notification Assessment (SNA) lifecycle from initial intake through closure ensuring timely, compliant, and risk-based evaluation of supplier change notifications
• Perform intake review and triage of supplier notifications, utilizing critical thinking and risk-based decision-making to assess impact and determine required actions.
• Prioritize, maintain, and own SNA records to ensure compliance with established timelines and quality requirements.
• Coordinate timely assignment for cross-functional impact assessments, ensuring timely completion and follow-up of actions through status tracking.
• Manage communications with suppliers in response to supplier change notifications received to obtain additional information, clarification, and supporting documentation as needed.
• Review and summarize impact assessment outcomes, facilitate stakeholder discussions, and support decision-making for required actions.
• Ensure critical supplier changes are appropriately assessed and do not impact product quality, regulatory compliance, or patient safety.
• Initiate and drive improvements in visibility, consistency, and governance of supplier change management processes.
• Support the generation, analysis, and reporting of quality metrics, trends, and performance indicators related to supplier notifications.
• Support process improvements to streamline and integrate supplier quality processes across the Gilead network.

Supplier Quality Master Data Management

• Serve as a subject matter expert for supplier quality records across multiple systems and platforms.
• Conduct proactive data reviews to identify inconsistencies, gaps, and opportunities for process improvement.
• Manage, prioritize, and coordinate supplier quality master data change requests.
• Collaborate with cross-functional teams and system owners to implement data updates and resolve data integrity issues.
• Provide regular progress updates and status reporting on ongoing data management activities and projects.
• Lead and drive data remediation and clean-up initiative across Gilead business and quality systems, including inactive supplier reviews, approval status verification, missing data correction, and other system optimization projects.

Approved Supplier List (ASL) Management

• Perform routine review and reconciliation of Approved Supplier List (ASL) data against system records to ensure accuracy and compliance.
• Facilitate recurring ASL review meetings with cross-functional stakeholders to evaluate supplier status and required updates.
• Manage and prioritize ASL-related change requests and ensure timely implementation.
• Support and participate in global ASL integration, enhancement, and continuous improvement projects.

Education, Experience, Qualifications & Competencies

• 4+ years of experience in Quality Assurance, Supplier Quality, Quality Systems, Compliance, or related pharmaceutical/biotech functions.
• Experience working with supplier quality systems, supplier change management, master data management, and Knowledge of supplier master data requirements
• Experience with quality management systems and enterprise platforms such as Veeva, SAP, GPLM, or equivalent systems.
• Understanding of GMP, GDP, ICH, FDA, EMA, and global regulatory requirements.
• Strong analytical and critical-thinking skills with the ability to assess supplier quality impacts and prioritize activities effectively.
• Demonstrated ability to manage multiple priorities while maintaining compliance with timelines and quality requirements.
• Strong cross-functional collaboration, communication, and relationship-building skills.
• Ability to analyze trends, summarize findings, and present recommendations to stakeholders.
• Proficiency in managing detailed records and driving process improvements through data integrity initiatives.
• Strong analytical capabilities and problem-solving skills
• Continuous improvement mindset and experience. Lean Six Sigma Green Belt or higher is desirable.

The salary range for this position is: $136,340.00 - $176,440.00. 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*.

For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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