Quality Assurance Operations Specialist II

For Current Gilead Employees and Contractors:

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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
 

Role and Responsibilities:

• Interact with contract manufacturers to resolve quality issues with minimal supervision
• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. 
• Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met. 
• Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) 
• Works directly with CXOs to ensure overall quality compliance on a continuing basis as specified 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. 
• May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products. 
• Review and approve master batch records, labels, specifications and other pre-production documents for clinical Drug Substance (DS) and Drug Product (DP) in compliance with FDA and international health authority requirements
• Review executed production batch records, environmental monitoring data (as required), analytical data, and associated documentation, including any deviation and investigation reports related to lot release of DS/DP in support of product disposition

Essential Duties and Job Functions:

• Good working knowledge of Quality Systems and cGMP standards applicable to clinical development
• Ability to work on complex, non-routine assignments where analysis of the situation or data requires a review of identifiable factors
• Ability to effectively participate in cross-functional teams
• Ability to coordinate the planning, organization, and implementation of project deliverables within specified objectives
• An accountable team player who is detail and quality oriented with solid understanding of quality assurance principles, systems, and procedures
• Excellent attitude with strong verbal, written, and interpersonal communication skills
• Self starter, able to work independently
• Able to travel infrequently (less than 5%)

Basic Qualifications:

• 4+ years of relevant GMP experience in the Biopharmaceutical or Pharmaceutical industry and a BS. 
• 2 + years of relevant GMP experience and a MS. 
• Demonstrates working knowledge of current Good Manufacturing Practices (GMPs). 
• Demonstrates working knowledge of quality assurance systems, methods and procedures. 
• Demonstrates knowledge of FDA / EMEA standards and quality systems. 
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