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Assoc Director – Quality Assurance

Assoc Director – Quality Assurance

CompanyGilead Sciences
LocationSan Mateo, CA, USA
Salary$182070 – $235620
TypeFull-Time
DegreesBachelor’s, Master’s
Experience LevelSenior, Expert or higher

Requirements

  • Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs).
  • Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.
  • Demonstrates excellent verbal, written and interpersonal communication skills.
  • Experience as an effective people leader, driving high performance, developing talent, and resolving issues.
  • Demonstrates some knowledge of Six Sigma tools, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement approach.
  • Demonstrates working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)).
  • 10+ years of relevant experience in a GMP environment related field and a Bachelor’s degree in science or related fields.
  • OR 8+ years of relevant experience in a GMP environment related field and a Master’s degree in science or related fields.

Responsibilities

  • Manages QA personnel responsible for batch review and lot disposition activities, including organizing and prioritizing group tasks, performing training, and writing performance reviews.
  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. Ensures compliance with current Good Manufacturing Practices (GMPs).
  • Acts as an initial point of business escalation and provides guidance to staff on path-forward options.
  • Participates in developing Standard Operating Procedures (SOPs) to ensure quality across internal and CMO operations related to Packaging and Labeling.
  • Ensures that the quality of products conform to established standards and agency guidelines.
  • Works directly with operating entities to ensure that inspections, audits and statistical process control analyses are conducted on a continuing basis.
  • Participates in compliance audits as required. Interfaces with contract manufacturers to address performance or compliance issues.
  • May interface with regulatory agencies as required.
  • Writes and/or implements changes to controlled documents (e.g., SOPs, work instructions) as needed.
  • Some positions at this level may specialize in transferring and driving quality initiatives across CMO organizations – this would include areas like CMO technology transfer, CMO process improvement, etc.

Preferred Qualifications

    No preferred qualifications provided.