Gilead Sciences Inc

Associate Director, Quality Assurance- GMP Operations

Gilead Sciences Inc • $100K — $130K *
Edmonton, AB T5A 0A1In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • Bachelor's in a scientific discipline with 10+ years in Quality Assurance; or Master's with 8+ years; or equivalent combination of education and experience.
  • Hands-on experience in GMP Manufacturing and QC operations.
  • Proven leadership in batch disposition, investigations, CAPA, and change management.
  • Familiarity with Health Canada, FDA inspections is a plus.
  • Expertise in materials management, manufacturing and analytical testing systems in a GMP setting.
  • People management experience is essential.
  • Strong communication and collaboration skills.

Responsibilities

  • Oversee GMP Manufacturing, QC testing, and Supply Chain operations throughout the product lifecycle.
  • Implement Quality Risk Management principles in operations.
  • Collaborate with teams to identify and manage quality risks affecting product quality and patient safety.
  • Ensure quality risk decisions are documented and compliant with internal and regulatory guidelines.
  • Partner with operations to address quality issues in manufacturing and testing.
  • Review and approve documentation related to manufacturing and quality processes.
  • Assess operational risks for new product introductions.

Benefits

  • Relocation assistance for qualified applicants.
Full Job Description
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.

About Gilead Sciences Inc

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet need. With each new discovery and experimental drug candidate, they seek to improve the care of patients suffering from life-threatening diseases. Gilead's primary areas of focus include HIV/AIDS, liver disease, and serious cardiovascular and respiratory conditions.

Gilead Sciences Inc Careers

Join the vibrant team at Gilead Sciences Inc, a leader in the biopharmaceutical industry known for its innovative approach to healthcare. At Gilead, we are committed to advancing the care of patients around the globe through rigorous science and research.

Work You’ll Do

Embark on a career journey with Gilead Sciences Inc, where job opportunities abound in a variety of fields, from scientific research to marketing and sales. Our team is dedicated to fostering an environment of diversity and inclusion, where every employee can thrive.

Innovate and Lead

At Gilead, innovation is at the core of everything we do. Join us and contribute to our mission of saving lives through advanced treatments and cutting-edge medicine. Our leadership is committed to nurturing professional growth, making Gilead an ideal place for those who aim to lead and innovate in the healthcare industry.

Grow Your Career

Gilead Sciences Inc offers a wealth of career advancement opportunities. With personalized career development programs, employees are encouraged to pursue their professional interests and expand their skills. Whether through on-the-job learning, formal training, or leadership development, we provide the tools necessary for long-term career growth.

Be Part of Our Team

Our team at Gilead Sciences Inc is composed of passionate, curious, and solution-driven professionals. By joining us, you’ll collaborate with some of the brightest minds in the industry. Our culture promotes teamwork and an interdisciplinary approach to problem-solving, making our workplace dynamic and innovative.

Internship and Employment Opportunities

Start your career with Gilead through our internship programs, which offer hands-on experience in biopharmaceutical development and business operations. For seasoned professionals, our employment opportunities span across various disciplines, inviting you to bring your valuable skills to our team.

Benefits and Culture

Gilead Sciences Inc is not only a great place to work but also offers competitive benefits designed to support the health, well-being, and financial security of our employees and their families. From health insurance to retirement plans and wellness programs, we ensure our team members are taken care of.

Networking and Professional Development

We emphasize the importance of networking and professional development within the company. Regular workshops, seminars, and training sessions are held to enhance your skills and knowledge. Additionally, Gilead’s strong emphasis on internal networking allows for cross-departmental collaboration and innovation.

Join Our Hiring Events

Stay connected with Gilead by joining our hiring events and exploring open positions that match your skills and interests. We are always on the lookout for dedicated, creative, and driven team players. Prepare your resume, ace the interview, and take the first step towards a fulfilling career at Gilead Sciences Inc.

Explore Jobs at Gilead Sciences Inc

Discover the exciting career opportunities waiting for you at Gilead Sciences Inc. Visit our careers page to search for open positions, read about our company culture, and learn how you can make a difference in the global healthcare landscape.

Stay Up to Date

Keep informed with the latest company news, career tips, and industry insights—all from the people who work at Gilead Sciences Inc. Subscribe to our job alert emails and personalize your experience to receive updates that align with your career preferences. Join Gilead Sciences Inc today and be part of a team that values innovation, leadership, and a commitment to diversity and employee growth.
Learn more about Gilead Sciences Inc
Size
14,400 employees
Market Cap
$107.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$123 million
Founded
1987
5 Year Trend
-2.1%
Revenue
$24.6 billion
NASDAQ
GILD
* Ladders Estimates

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