Manager, Quality Assurance Compliance

Gilead Sciences•Foster City, CA

17h

About The Position

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).

Requirements

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.

Nice To Haves

Lean Six Sigma Green Belt or higher is desirable.

Responsibilities

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.
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.
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.