Senior Specialist, Quality Assurance

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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

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. We are seeking a highly motivated individual to join us as a Senior Specialist, Quality Assurance for the Gilead Alberta Quality Assurance department. This role involves collaborating with multi-disciplinary cross-functional teams to ensure that QC testing complies with Quality and Regulatory requirements through its lifecycle.

Responsibilities

• Review and approve analytical test methods and method validation/transfer reports.
• Review and approve lab investigations associated with release testing, equipment cleaning, and method validation/transfer at the site or at contract testing laboratories.
• Perform QA review of analytical testing data, including data audit trails.
• Participate in authoring, review, and approval of new or revised standard operating procedures, forms, test methods and other controlled documents to ensure compliance with current Good Manufacturing Practices (GMPs).
• Support internal and external audits, site inspection readiness activities, and continuous improvement initiatives.
• Review and approve analytical instrument qualification protocols and reports, as needed.
• Participate in review and approval of Deviations, CAPAs, and Change Management records associated with analytical operations, as required.
• Participate in Quality Risk Management activities to support site operations.
• Participate in the development and deliverance of GMP training, as required.
• Work with diverse and cross-functional teams to support site activities, and independently manage responsibilities, including organizing and prioritizing daily tasks.
• Utilize critical thinking abilities and risk-based judgment to solve routine to complex problems and recommend actions.
• Communicate with cross-site teams to align practices and drive continuous improvement.
• Provide analytical technical guidance and training to other members of the QA team.

Basic Qualifications

Bachelor’s degree in chemistry, or a related field, and 6+ years of relevant experience in a GMP environment.

OR

Master’s degree in chemistry, or a related field, and 4+ years of relevant experience in a GMP environment.

OR

PhD in chemistry, or a related field. Experience in a GMP environment is preferred.

Preferred Qualifications

• Experience with analytical method development, verification, validation and transfer are required.
• Knowledge of GMP regulations, including ICH Q7, Q9, Q10 is preferred.
• Experience across broad areas of Quality Assurance and/or Quality Control Systems is preferred.
• Must be able to think critically and creatively, solve routine to complex problems, work independently, and have strong organizational and planning skills.
• Demonstrated ability to develop, coach and mentor employees is an advantage.
• Experience in Quality Risk Management activities is preferred.
• Excellent interpersonal, verbal, and written communication skills.
• Knowledge of Six Sigma, DMAIC methodology, risk management tools, and/or quality improvement statistical tools would be an asset.

People Leader Accountabilities

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

Gilead Core Values

• Integrity (Doing What’s Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)