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Sr Manager, Quality Assurance

Job Description Department Overview: Quality Assurance delivers on Gilead's commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies. As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining QA within PDM, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases. Specific Responsibilities 2nd shift QA operations manager and primary quality contact for the resolution of quality related issues (supporting Manufacturing, Supply and Distribution, Maintenance, Metrology and Quality Control) during the second shift (Sunday through Thursday, 1400-2200). Responsible for the management of quality personnel performing product and component sampling and inspections, batch record review, quality oversight and the review/approval of associated quality documents. Responsible for the management and scheduling of quality personnel to ensure adequate support of the manufacturing and lot release schedules. Reviews manufacturing records, environmental monitoring records, SOPs, validation documentation and quality control records for in-process and finished products. Essential Duties and Job Functions Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements. Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews. 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 current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs). Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products. Responsible for final release of manufactured products. 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. May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products. Serves as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products. May lead compliance audits as required. Interfaces with contract manufacturers to address and resolve more complex product/process performance issues. Works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes. May interface with regulatory agencies as required. Knowledge, Experience, and Skills Demonstrates in-depth knowledge of GMPs and/or GLPs. Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards. Demonstrates excellent verbal, written, and interpersonal communication skills. Demonstrates keen understanding of international quality systems regulations to adopt best in class systems/processes, and drive continuous improvement initiatives. 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. 8+ years of experience in a GMP environment related field and a BS or BA. 6+ years of relevant experience and a MS. If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: About Gilead: Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions R0006103
Salary Range: NA
Minimum Qualification
8 - 10 years

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