Senior Specialist, Quality Management

2 weeks ago

Cambridge, United Kingdom Gilead Sciences Full time

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

Senior Specialist, Quality Management within Strategic Operations, Patient Safety

The Patient Safety (PS) department is a global function that is part of the Development organisation within Gilead. The main Pharmacovigilance activities of PS are centered at three sites: Foster City and Santa Monica in the USA and Cambridge in the UK.

This role is based in Cambridge in the PS Strategic Operations (SO) team, which is responsible for ICSR excellence & operational support of clinical studies, PS alliances & vendor management, operational standards & audit and inspection readiness/support, PS process & training deliverables, medical device expertise and PS systems.

This role is part of the Standards & Inspection Readiness Team, which is the team that establishes standards and targets for quality across operational deliverables for both in-house and outsourced activities, monitors and trends against key performance indicators, maintains inspection readiness across SO and leads inspection and audit activities for SO related processes.

We are seeking a PS expert to manage and support the execution of strategy and ensure operational excellence in the following areas:

Quality control for both in-house and outsourced ICSR processing Support establishment of new standards and development of new QC strategies

Expectations for the above activities includes understanding of global PV regulatory requirements related to the collection, processing and submission of ICSRs both from the clinical trial and post-marketing setting, knowledge of end-to-end ICSR processing, PS interfaces with internal and external sources of safety data, experience in assessment of high-volume and complex data sets, solution-oriented cross-functional collaboration.

Core responsibilities include, but are not limited to the following:

Performs quality control (QC) checks for ICSRs to ensure accuracy and compliance with Gilead conventions and regulatory standards. Develops and/or assists with routine or ad-hoc reviews of processes or data entry conventions to ensure compliance with departmental SOPs and guidelines. Reviews datasets for trends and may suggest appropriate corrective actions. Liaises with Safety Physicians and coding team as required to ensure appropriate medical review and coding assessment is provided for assigned case reports. Supports with the oversight of outsourced QC activities to ensure quality and accuracy of deliverables, and that timelines are met appropriately. Identifies issues/concerns in a timely and appropriate manner and provides possible solutions. Participates in process improvement initiatives as required.

Job Skills:

Experience analyzing, interpreting and reporting data / information in a PV environment. Experience working with drug safety / PV or related systems, databases, and tools. Strong communication and writing skills and proficiencies with Microsoft Office suite, as evidenced through abilities to assume assignments and projects with increasing independence. Works independently with demonstrated ability to prioritize own work, as evidenced by consistently effective results from previous roles. Ability to work effectively in cross-functional teams and projects. Expected to proactively identify opportunities to increase departmental efficiencies, effectiveness, and optimize resources. Able to act as a representative on cross-functional teams and/or projects, and internal audits. May participate in assigned projects such as inspection readiness activities or inspection interviews.

Education and Experience: At a minimum, the ideal candidate will possess:

BA/BS or advanced degree in life sciences or related field with relevant experience in the biopharma industry, regulatory agency, clinical research, or other related healthcare environment, including experience working with medical terms and exposure to GCP and GVP. Resource and workload management experience. Has an excellent knowledge and understanding of applicable global regulatory requirements.


For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections, please view the ‘Know Your Rights’ poster.

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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For jobs in France:

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