At Gilead, we strive to transform the promise of science and technology into therapies that have the power to cure, prevent or treat disease. As a research-based biopharmaceutical company, we are revolutionizing healthcare by bringing medicines to patients in the areas of HIV, AIDS, liver diseases, hematology and oncology, and inflammation and respiratory diseases. We are growing a diverse team of professionals and an atmosphere that promotes diversity, equality and inclusion across departments. We need your unique talents, expertise and background to help millions of people around the world live healthier. Join a close community where every voice is heard; where you can see and measure the results of your contributions. Our values - integrity, inclusion, teamwork, accountability and excellence are evident in everything we do.
Reporting to the Director, Quality Engineering, the Associate Director will play a critical role in leading Operational Excellence initiatives. Your role as leader and problem solver will ensure that Quality Engineering initiatives are appropriately coordinated to completion and will apply structured change management and process improvement techniques to ensure successful adoption of large-scale transformations and key Quality Engineering projects.
Leads DMAIC projects and facilitates workshops throughout the continuous improvement lifecycle, from ideation to change sustainment.
Monitors overall quality engineering project portfolio, provides mid-range planning, and communicates project outcomes.
Facilitates Analytics/Metrics Programs and provides consultation on leading indicators
Designs and delivers Lean Six Sigma classes and mentors Yellow/Green Belt candidates
Provides data analysis for key insights in decision making
Manages and provides guidance to team members, including organizing and prioritizing group tasks, performing training, and managing performance.
Maintains Quality Engineering programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines.
Analyzes, revises and develops internal procedures and systems required to ensure GMP compliance.
Manages complex processes across functions and interacts effectively with the other team members to ensure product meets regulatory, performance, and cost requirements.
Knowledge and Skills:
Demonstrates expertise in Quality Engineering principles, concepts, industry practices, and standards.
Demonstrates expertise in Lean Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures, and quality improvement.
Demonstrates excellent verbal, written and interpersonal communication skills.
Demonstrates ability to effectively interact with all levels of the organization.
Demonstrates in-depth knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)).
Understands and can apply Data Science/Advanced Analytics in solving problems.
Education and Experience:
10+ years of relevant experience in the pharmaceutical industry and a BS or BA in engineering or science related degree OR 8+ years of relevant experience and a MS.
Certification by ASQ (Certified Six Sigma Black Belt, Certified Quality Engineer, and Certified Quality Manager) with Black Belt Certification strong preferred
Prior people management experience.
Knowledge and experience in quality engineering/operational excellence in a highly regulated manufacturing environment