Manager / Sr. Manager, Quality Assurance, Commercial QA

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
 

• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
• Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined quality objectives are met.
• Implements and maintains programs and processes to ensure high-quality products and compliance with GQP/GMP/GDP.
• Manages the training department, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
• Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
• Release products.
• Manage Change Control in collaboration with CMC and related groups.
• Works extensively with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications.
• Ensure that Quality Systems and practices are developed and implemented across contracted manufacturing organizations, third-party logistics providers (3PLs), contracted distributors and other service providers engaged by the Japanese Affiliate in any aspect of packaging and distribution of Gilead’s products, in accordance with relevant GQP&GMP&GDP regulations.
• Serves as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
• Leads authorities’ inspection activities by submitting GMP Compliance Inspection and obtaining the GMP Compliance Certificate for all sites related to J-NDA, PCA, and APIs of Drug Master Files.
• Leads consistency checks between NDA filing and site operation documents in collaboration with global sites.
• Works with Research and Development during new product start-ups and establishes key checkpoints for new products and processes.

• Acts as a deputy of the Quality Assurance Officer (品質保証責任者代行), overseeing and executing GQP/GDP operations in the officer’s absence.
• Leads QA oversight for complex products, including sterile products, biologics, and other technically or operationally complex products.
• Owns and provides strategic oversight for complex QMS areas such as Change Control, Deviation Management, CAPA, and related quality governance processes.
• Leads projects with broader scope, higher complexity, and significant cross-functional impact, including launches, site transfers, process improvements, and global/local quality initiatives.
• Provides expert guidance to Quality Assurance Officer and team members on complex quality issues, risk-based decision-making, and interpretation of GQP/GMP/GDP requirements.
• Drives continuous improvement and strengthens governance across key Commercial QA processes.

Knowledge & Skills

Must Have

• Excellent Japanese business communication skills.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Demonstrates in-depth knowledge of PMD. Act (薬機法), GMP, GQP and GDP.
• Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.
• Demonstrates resourcefulness, critical thinking, and objectivity to integrate the quality philosophy into the daily operations of the organization.
• Navigates the gray, is adaptable, flexible, and open to change point of view to reach win-win solutions.
• Uses existing resources and seeks new ways to improve performance of people, processes, and systems.

Nice to have

• Demonstrates knowledge of Information Systems Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements.
• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistics.
• 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.

Education & Experience

Must Have

• 5+ years of QA relevant experience in the pharmaceutical industry and a Bachelor of Science (or equivalent).
• 3+ years of QA relevant experience with Quality Management System.
• Experience with Electronic Document Management Systems or other GXP applications.

Nice to have

• Experience in Project Management for Launch, site transfer and analytical transfer.
• Experience in analytical, process chemistry and/or formulation development.
• Experience in GMP compliance inspections, FMA and Conformity check.
• Experience in Biologics and Cell Therapy.

Please apply via the Internal Career Opportunities portal in Workday.