Sr Manager, Quality Assurance

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 fulfill their aspirations. Join Gilead and help create possible, together. Job Description   The role supports QA function's commitment to operating in accordance with cGMP and maintaining a quality system that ensures compliance with regulatory requirements. We are looking for a QA professional to provide leadership and direction for Quality Systems, ensuring the effective operation and continuous improvement of the site Quality Management System within a highly regulated pharmaceutical manufacturing environment. Lead through clear expectations, robust Quality System oversight, effective use of quality data, people development and cross-functional collaboration. Promote a strong culture of quality, compliance, data integrity, accountability and continuous improvement Key Responsibilities   Quality Management Systems Provide leadership and oversight for Quality Systems activities, ensuring effective implementation and maintenance of the Quality Management System. Ensure activities are conducted in accordance with established SOPs, company and departmental policies and procedures, cGMP and applicable regulatory requirements.   Quality System Performance & Management Review Establish effective oversight of Quality System performance through appropriate metrics, trending and review of quality data. Use Quality System information to assess effectiveness, identify emerging issues and opportunities for improvement, and support effective Quality Management Review and management decision-making.   Compliance & Regulatory Standards Maintain current knowledge of relevant manufacturing standards, product regulations and global regulatory requirements. Provide Quality Systems leadership to support consistent application of regulatory and company requirements and promote a strong culture of compliance across the site.   Complaint and APQRs Provide leadership and quality oversight for the Product Complaint and APQR Quality Systems, ensuring regulatory compliance, effective governance and continuous improvement. Maintain oversight of investigation quality, complaint and product-quality trends, APQR execution and identification of emerging or systemic risks. Ensure significant trends and cross-functional or cross-site issues are appropriately escalated through Quality governance and translated into meaningful corrective, preventive and continuous improvement actions.   Data Integrity & Electronic Quality Systems Ensure Quality Management Systems are maintained in alignment with data integrity principles. Support the effective use of relevant electronic systems and software used in Quality Systems activities, including electronic document and learning management systems as applicable.     Cro