Associate Director, Quality Assurance- GMP Operations

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

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.

• 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.

• 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.

• 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.

• 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.

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

• 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.

Please apply via the Internal Career Opportunities portal in Workday.