QA Specialist II

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

Responsible for clinical and commercial complaint investigations.

Responsible for tracking and trending of complaints across all Gilead Sciences sites and presents data periodically for Quality Management Review

Leads and co-ordinates complex complaint investigations, including development and implementation of corrective actions.

Interfaces with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorates. Prepares and presents Complaint data to the regulatory agency inspections.

Writes and/or implements changes to controlled documents (e.g., SOPs, investigational protocols etc.) as needed.

Supports Annual Product Quality Reviews, CCPRs and trend analysis reporting related to commercial product complaints.

Escalates Critical and Major Complaints timely and presents them to senior management.

Collaborates cross functionally and geographically with stakeholders to ensure alignment of complaint management process.

Develops an effective working relationship with Gilead Sites, CMOs, and Patient Safety.

Supports development and implementation of strategic Quality assurance programs and initiatives.

Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.

Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).

Develops solutions to more complex problems, identifies variance from accepted practice, and evaluates impact as necessary.

Provides guidance and technical knowledge to more junior staff, monitors the performance of daily tasks.

Normally receives no instruction on routine work, general instructions on new assignments.

Bachelor’s degree and 4+ years of relevant experience in a GMP environment related field; OR

Master’s degree and 2 + years of relevant experience

Prior experience in pharmaceutical industry is preferred

Demonstrates proficiency in Good Manufacturing Practices (GMPs).

Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards.

Demonstrates thorough knowledge of FDA/EMEA standards and quality systems and the interface with other functions like manufacturing, distribution and maintenance.

Demonstrates strong verbal, technical writing and interpersonal skills.

Demonstrates proficiency in Microsoft Office applications.

Integrity (Doing What’s Right)

Inclusion (Encouraging Diversity)

Teamwork (Working Together)

Excellence (Being Your Best)

Accountability (Taking Personal Responsibility)

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…