R&D Quality Specialist -Biopharma

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RESPONSIBILITIES:

• You will act as R&D Quality primary point-of-contact for assigned R&D groups for quality events and CAPA management. You may have responsibilities for advising R&D groups on quality events, inspection and CAPA management and administration practices and standards, including advising on appropriate CAPA activities to address quality events and deviations. You may also lead special projects, such as new practices, processes or tools that enable continuous evolution and streamlining for R&D inspections and CAPA management. You will support regulatory inspection activities, provide quality event and CAPA management training and in training new team members on departmental policies, practices and procedures. Work includes:

• Gilead policies, practices, procedures, and regulatory requirements
• Gilead systems (electronic Quality Management System) and other tools for managing quality events, deviations, and CAPAs
• Activities required to address quality incidents or deviations, including specific advice on appropriate corrective and preventative actions (CAPAs)
• Regulatory and Gilead requirements for regulatory inspections and responses to regulatory agency inquiries

• Will support internal R&D for assigned R&D groups or locations.

• Conducts inspection and CAPA management activities, such as managing quality events in the electronic Quality Management System CAPA report issuance, audit and CAPA management follow-up and associated communications, and audit and CAPA closure.

• May provide R&D Quality support for inspections and CAPA management administrative and systems support, such as:

• Managing, tracking and reporting on R&D quality inspections, quality events such as deviations, and CAPA management
• Providing systems and reporting training to others
• Performing quality checks on data and reporting to ensure accuracy, completeness and complianceSupporting administrative coordination, scheduling and reporting related to R&D Quality inspections

• Participates in continuous improvements to R&D quality audits, inspections and CAPA management processes, policies, procedures, practices and tools.

• Will support GxP training for other colleagues and train new team members on departmental policies, practices and procedures.

• Fosters a commitment to quality in individuals and a culture of quality across Gilead R&D and with R&D vendors.

• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

BASIC REQUIREMENTS:

• MA/MS/MBA with 2+ years’ relevant experience.

• BA/BS with 4+ years’ relevant experience.

PREFERRED REQUIREMENTS:

• Experience working with quality-controlled document management systems is strongly preferred.

• Experience writing or updating business processes is preferred.

• Quality and compliance experience working with medicinal products in the biopharma industry is preferred.

• Demonstrated ability to be a fast learner.

• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.

• Demonstrates advanced knowledge of quality and compliance requirements for medicinal products, including varying regional requirements.

• Demonstrates strong attention-to-detail and good organizational skills.

• Demonstrates strong proficiencies in the Microsoft Office suite.

• Good project management skills, as evidenced by ability to manage multiple assignments simultaneously without compromise to timelines or quality.

• Ability to communicate in a clear and concise manner.

• Ability to support a team-oriented, highly-matrixed environment.

• Ability to execute multiple tasks as assigned.