Associate Director, Quality Assurance- GMP Operations

Description

Job Summary

The Associate Director, Quality Assurance – GMP Operations provides senior Quality leadership and direct quality oversight of Manufacturing, Quality Control (QC), and Supply Chain activities at the Alberta site. This role ensures GMP compliance across day-to-day operations through effective quality risk management, supports efficient and reliable manufacturing execution, and maintains inspection readiness. The position partners closely with Manufacturing, QC, and Supply Chain teams to enable compliant, risk-based decision making, timely product disposition, and continuous improvement while maintaining patient safety and product quality.

This is a site based role at our facility in Edmonton, Alberta. We will offer relocation for qualified applicants.

Essential Job Functions

GMP Operations Quality Oversight

• Provide Quality Assurance oversight of GMP Manufacturing, QC testing, and Supply Chain operations through the product lifecycle.
• Apply Quality Risk Management principles to support Manufacturing, QC, and Supply Chain operations.
• Partner with cross-functional teams to identify, assess, and mitigate quality risks impacting product quality, patient safety, and supply continuity.
• Ensure quality risk decisions are appropriately justified, documented, and aligned with internal procedures and regulatory expectations.
• Partner with Manufacturing operations, QC, and Supply Chain to resolve quality issues arising during manufacturing, laboratory activities and material receipt and shipping.
• Review and approve manufacturing and test records, deviations, investigations, change controls, and CAPA to ensure product quality and support timely product disposition.
• Evaluate operational and quality risks related to new product introduction.

Compliance, Audits & Inspections

• Participate in internal GMP audits and routine walk-throughs of Manufacturing, QC, and Warehouse areas to support continuous improvement.
• Serve as a key Quality contact during regulatory inspections and internal audits, including preparation and response to findings.
• Monitor regulatory requirements and proactively assess potential operational compliance risks.

Quality Systems & Documentation

• Approve GMP documentation including procedures, master batch records, specifications, and analytical methods.
• Ensure effective document and record control practices across Manufacturing, QC, and Supply Chain functions.
• Drive continuous improvement of quality processes supporting GMP operations.

Leadership & Collaboration

• Provide leadership, development, and mentoring for Quality personnel supporting GMP operations.
• Partner cross-functionally with Manufacturing, QC, Process Development, Engineering, Supply Chain, and Quality management on corporate and site initiatives.
• Lead or support Quality-related operational projects and improvement initiatives.
• Provide on-call Quality Assurance support to Manufacturing and QC operations, as required.
• Use risk-based decision making to prioritize tasks and ensure product quality.
• Maintain strong working knowledge of Health Canada, FDA, and global GMP expectations.

Basic Qualifications

Bachelor’s degree in a scientific discipline with 10+ years of Quality Assurance experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment; OR a Master’s degree with 8+ years of relevant experience; OR an equivalent combination of education and experience.

Qualifications

• Extensive hands-on experience supporting GMP Manufacturing and QC operations is required.
• Proven experience leading batch disposition, investigations, CAPA, and change management in a GMP operational environment is required.
• Experience supporting Health Canada, FDA, or other regulatory inspections would be beneficial.
• Strong understanding and experience of materials management, manufacturing and analytical testing systems within a GMP environment.
• Previous experience in people management is essential.
• Strong cross-functional collaboration and communication skills are required.
• Previous experience in a management role within Quality is required.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.