Associate Director, Quality Assurance- GMP Operations

Job summary

The Associate Director provides senior quality leadership and oversight for manufacturing, quality control, and supply chain activities at the Edmonton site. They are responsible for ensuring GMP compliance, managing quality risks, and facilitating timely product disposition while mentoring quality personnel.

Job details

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 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.

What you’ll do

The Associate Director provides senior quality leadership and oversight for manufacturing, quality control, and supply chain activities at the Edmonton site. They are responsible for ensuring GMP compliance, managing quality risks, and facilitating timely product disposition while mentoring quality personnel.

Requirements

Candidates must hold a Bachelor's degree in a scientific discipline with at least 10 years of GMP-regulated pharmaceutical experience, or a Master's degree with 8 years of experience. Proven experience in people management and hands-on oversight of GMP operations is essential.

Benefits

• Relocation assistance

Listed skills

• Change Management · Preferred
• Quality assurance · Preferred
• Regulatory Compliance · Preferred
• Cross-Functional Collaboration · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Quality Assurance
• GMP Operations
• Quality Risk Management
• Manufacturing Oversight
• Regulatory Compliance
• Batch Disposition
• CAPA
• Change Management
• Health Canada Regulations
• FDA Regulations
• Supply Chain Oversight
• People Management
• Cross-functional Collaboration
• Audit Preparation
• Quality Systems
• Documentation Control
• Compliance Auditing
• Cross-Functional Collaboration
• Supply Chain Risk and Continuity Planning
• Supply Chain
• Analytical Testing
• Compliance Risk
• Analytical Method
• Auditing
• Biotechnology
• Management
• Good Manufacturing Practices
• Corrective And Preventive Action (CAPA)
• Change Control
• Decision Making
• Communication
• Continuous Improvement Process
• Warehousing
• Leadership
• Patient Safety
• Leadership Development
• Product Lifecycle Management
• Risk Management
• Manufacturing Operations
• Materials Management
• Mentorship
• New Product Development
• Operations
• Pharmaceuticals
• Process Development
• Quality Management
• Product Quality (QA/QC)
• Investigation
• Quality Control

Job areas

• Healthcare
• Management & Leadership
• Manufacturing
• Science & Research
• Engineering
• Director of Quality Assurance
• Management and Organization Analysts
• Quality Control Systems Managers
• Industrial Production Managers