About Gilead Sciences

Gilead Sciences is a leading biopharmaceutical company dedicated to creating a healthier world for all people. For more than 35 years, Gilead has pioneered therapies tackling some of the world's most pressing health challenges, including HIV, viral hepatitis, COVID-19, and cancer. Our relentless pursuit of innovation extends to oncology and inflammatory diseases, where we develop life-changing treatments that improve patient outcomes and ensure global access to care. Headquartered in the U.S. with a strong presence in Canada, Gilead fosters a collaborative environment driven by determination and scientific excellence. Every team member contributes to our bold mission, making direct impacts on groundbreaking discoveries.

Role Overview

The Sr QA Specialist position at Gilead Sciences in Edmonton, Alberta, is a pivotal role within our Quality Assurance team. This full-time opportunity involves applying critical thinking and risk-based judgment to manufacturing challenges in a GMP-regulated environment. You will ensure compliance, drive continuous improvement, and provide oversight for drug substance manufacturing activities. Ideal for seasoned professionals passionate about biopharmaceutical quality systems, this role offers the chance to mentor others while contributing to therapies that combat HIV, oncology, and inflammatory diseases.

Key Responsibilities

• Apply critical thinking and risk-based judgment to routine and complex manufacturing challenges, ensuring continuous improvement.
• Review and approve documentation and records, including batch records, materials management, cleaning, and analytical data.
• Support manufacturing investigations, deviations, CAPAs, and change controls.
• Participate in authoring, reviewing, and approving SOPs, forms, and controlled documents for GMP compliance.
• Provide QA oversight during operations and collaborate with cross-functional teams.
• Support audits, inspection readiness, and Quality System harmonization, including electronic implementations.
• Engage in Quality Risk Management and mentor Quality group members.

Qualifications & Requirements

To excel as Sr QA Specialist, candidates need a strong foundation in chemistry and GMP environments. Required qualifications include:

• Bachelor's degree in chemistry or related field with 6+ years of relevant GMP experience.
• Master's degree in chemistry or related with 4+ years of experience.
• PhD in chemistry or related field with relevant experience.

Preferred skills encompass analytical method development, validation, GMP regulations (ICH Q2, Q7, Q9, Q10), Quality Assurance/Control systems, Six Sigma/DMAIC, risk management tools, and mentoring abilities. Excellent communication, organizational skills, and independent problem-solving are essential.

Benefits & Perks

Gilead Sciences offers a premium compensation package for the Sr QA Specialist role in Edmonton. While salary is estimated at CAD 90,000 - 150,000 annually, benefits include comprehensive health coverage, retirement plans, and wellness programs. Enjoy professional development resources, tuition reimbursement, and employee assistance programs. Our inclusive culture promotes work-life balance with flexible scheduling and paid time off. As part of a global leader, you'll access cutting-edge facilities and contribute to impactful work in HIV treatments, oncology innovations, and inflammatory disease therapies.

Career Growth

At Gilead, career advancement is a priority. As a Sr QA Specialist, you'll receive guidance and mentorship while having opportunities to lead Quality initiatives. Our people leaders drive an empowering environment where employees develop skills in electronic Quality systems, risk management, and cross-functional collaboration. Many advance to managerial roles or specialize in audit readiness and continuous improvement. Gilead's commitment to employee aspirations ensures pathways to senior positions, fostering long-term growth in biopharma.

Why Join Gilead

Joining Gilead means becoming part of a team relentless in fighting health challenges. In Edmonton, you'll work on therapies advancing HIV care, oncology breakthroughs, and solutions for inflammatory diseases. Our collaborative culture values every voice, promoting inclusion and innovation. With strong leadership and a focus on employee experience, Gilead empowers you to make a difference. Experience the pride of contributing to global health while enjoying a supportive, ambitious workplace.

Role FAQs

Q: What experience is required?
A: Minimum 4-6+ years in GMP environments, depending on degree level in chemistry or related fields.

Q: Is prior QA oversight experience necessary?
A: Yes, experience in manufacturing QA, investigations, and SOPs is highly preferred.

Q: What GMP knowledge is expected?
A: Familiarity with ICH Q2, Q7, Q9, Q10, and risk management tools.

Q: How does Gilead support career development?
A: Through mentorship, training in Six Sigma/DMAIC, and leadership opportunities.

Q: Is this role remote?
A: No, it's on-site in Edmonton, Alberta, supporting manufacturing operations.

This SEO-optimized role description highlights Gilead's legacy in biopharma, positioning the Sr QA Specialist as a key career move for quality professionals. Apply now to shape the future of healthcare.