Specialist III, Quality Assurance (Quality Systems)

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 fulfill their aspirations. Join Gilead and help create possible, together.

Job Description

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. The Specialist III, Quality Assurance is an experienced Quality professional responsible for the administration, oversight, compliance, and continuous improvement of Quality Management System (QMS) processes at Gilead Alberta.

The position serves as a Quality Systems subject-matter expert and provides independent oversight and guidance for regulatory compliance, inspection readiness, audits, quality metrics, training programs, documentation, and electronic quality systems.

The role partners with cross-functional stakeholders and global Quality functions to maintain a sustained state of inspection readiness, assess quality system effectiveness, identify and address compliance risks, and lead improvements that strengthen the site's Quality Management System.

Specific Job Responsibilities:

Quality Systems Oversight and Continuous Improvement

• Provide independent oversight and subject-matter expertise for assigned Quality Management System processes.
• Monitor and assess quality system performance, compliance, and effectiveness and identify opportunities for improvement.
• Lead quality system improvement initiatives and cross-functional compliance projects.
• Support Quality Management Review through analysis of quality system performance, trends, risks, and improvement opportunities.
• Identify emerging compliance risks and recommend appropriate actions or process improvements.

Inspection Readiness and Regulatory Compliance

• Lead and support activities required to maintain a sustained state of inspection readiness.
• Coordinate the preparation, review, and organization of inspection-related documentation and evidence.
• Provide Quality guidance to cross-functional teams on inspection readiness and regulatory expectations.

Quality Metrics and Management Review

• Develop, analyze, trend, and report Quality System metrics and key performance indicators.
• Evaluate trends and identify recurring issues, emerging risks, or opportunities for improvement. Recommend actions based on quality system performance and trend analysis.
• Work with process owners to establish meaningful measures of process effectiveness and compliance.

Deviation, CAPA and Change Control Systems

• Provide Quality Systems expertise and oversight for deviation, CAPA, and change control processes.
• Advise users and process owners on Quality System requirements and appropriate record management.
• Support improvement of deviation, CAPA, and change control processes based on metrics, trends, inspection observations, and user feedback.

Documentation Management

• Author, revise, review, and maintain SOPs, work instructions, forms, standards, and other controlled Quality documents.
• Provide subject-matter expertise in document lifecycle management and procedural document requirements.
• Lead or support improvements to document control processes and associated electronic systems.

Training Systems

• Provide oversight and subject-matter expertise for site training programs and electronic learning systems.
• Support curriculum governance, training assignment processes, compliance monitoring, and training effectiveness activities.
• Analyze training compliance and system performance and identify areas requiring corrective action or improvement.
• Lead or support implementation and continuous improvement of training processes and systems.

Knowledge

You should have ...

• Strong technical writing, analytical, problem-solving, organizational, and communication skills.
• Experience interpreting and applying GMP requirements and Quality System procedures.
• Experience leading or contributing to cross-functional quality or continuous improvement initiatives.

Specific Education & Experience Requirements

• Bachelor's degree in Science or a related discipline and 5+ years of relevant experience OR
• Masters degree in Science or a related discipline and 3+ years of relevant experience
• 'Relevant' is classified as experience in Quality Assurance, Quality Systems, pharmaceutical manufacturing, biotechnology, or another regulated environment.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.