Associate Director, Quality Assurance

·        Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).

·        Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.

·        Demonstrates keen understanding of Computer Systems Validation and ICH Guidelines.

·        Demonstrates excellent verbal, written and interpersonal communication skills.

·        Demonstrates knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical.

·        Demonstrates working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)).

·        Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations.

·        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.

The salary range for this position is: $182,070.00 - $235,620.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

·        Experience supporting Health Canada, FDA, or other regulatory 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.

·        Approve GMP documentation including risk assessments, procedures, master batch records, specifications, and analytical methods. 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.