Assoc Director, Quality Assurance

Description de l'emploi

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. This is a people leader role within the QA Packaging and Labeling team in Gilead's External Quality Operations department. The ideal candidate will have established people leader experience and some packaging/labeling experience.

This is an onsite position based at our headquarters in Foster City, CA.

Knowledge:

• ​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)

Basic Qualifications:

• 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.

Specific Job 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.

People Leader Accountabilities

• 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.