Manager / Sr. Manager, Quality Assurance, Commercial QA

Job description

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 Management Is responsible for the Deputy of Quality Assurance Officer (品質保証責任者代行) Manages the operations of several areas of Quality Management System (QMS) within commercial QA including responsibility for work methods, operations excellence, managing costs. Project involvement Serves as a project lead within the function. Lead or serve as a key team member on cross-functional projects, which can have high visibility to senior management within the organization. Key Differentiating Contributions Responsible for maintaining and enhancement of Quality Management System (QMS) with regulatory requirements and Gilead global standards. Responsible for providing guidance on interpretation and application in accordance with relevant GQP&GMP&GDP regulations. Uses advanced statistical techniques for data analysis. Uses complex research techniques and methodologies such as six sigma and kaizen to improve process/product quality Independently initiates and develops new methods to facilitate management’s ability to make strategic decisions. Develops a strong relationship with stakeholders including Trade&Operation (Supply Chain& Wholesaler), CMC-RA, Corporate Quality, Customer Service, Regulatory, PV and Manufacturing to ensure that product distribution processes are aligned to the regulatory requirements and the needs of Gilead and its customers, ensuring best practice, compliance and alignment with business needs. Support any activities of Quality Head for Quality Management Review. Support any activities of Quality Assurance Officer with contributing to improvement and execution of All GQP/GDP activities including deviation, change management, Quality information, GQP/GDP training, Batch Record Review, CMO management, self-inspection and recall, as a deputy of Quality Assurance Officer Works on problems that are complex in scope where analysis of situations or data requires in-depth evaluation of various factors. Determines corrective action on investigative findings and with consideration of the long-term impact of decisions. Job Responsibilities 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. Oversight of embedded Document Coordinator program and qualification of Document Coordinators Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products. Responsible for final release of manufactured 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. May lead compliance audits as required. Works with Research and Development during new product start-ups and establishes key checkpoints for new products and processes. Works on authorities’ inspection by submitting GMP Compliance Inspection and getting GMP Compliance Certificate for all sites related J-NDA, PCA, and APIs of Drug Master Files. Works on consistency check between NDA filling and site operation documents in collaboration with global sites May interface with Japan agencies such as MHLW (Ministry of Health, Labor and Welfare) and PMDA (Pharmaceuticals & Medical Devices Agency) when any quality-related case is reported. Typical Education & Experience 10+ years of QA relevant experience in the pharmaceutical industry and a Master of Science. 5+ years of QA relevant experience with Quality Management System Experience with Electronic Document Management Systems or other GxP applications. Experience in Project Management for Launch, site transfer and analytical transfer. Experience in GMP compliance inspections, FMA and Conformity check. Experience in analytical, process chemistry and/or formulation development. Experience in Biologic and Cell Therapy is preferred. Knowledge & Skills Excellent Japanese and English 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. 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 statistical is preferred. Knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is preferred. Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is preferred. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.