R&D Quality Specialist

Kite Pharma • Santa Monica, CA

1d

About The Position

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. 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 Kite and help create more tomorrows. Job Description POSITION OVERVIEW: You may act as R&D Quality primary point-of-contact for assigned R&D groups for any RDQ responsibility. You may have responsibilities for advising R&D groups on process, learning and documents, quality events, inspection, vendor management and administration practices and standards, including advising on appropriate activities to address quality issues and compliance. You may also lead special projects, such as new practices, processes or tools that enable continuous evolution and streamlining for all of RDQs processes and management. You may support regulatory inspection activities, provide compliance and quality oversight to R&D groups and training new team members on departmental policies, practices and procedures.

Requirements

• MA/MS/MBA with 2+ years’ relevant experience.
• BA/BS with 4+ years’ relevant experience.
• Experience working with quality-controlled document management systems is strongly preferred.
• Experience writing or updating business processes is preferred.

Nice To Haves

• 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.

Responsibilities

• May act as a primary point-of-contact to assigned R&D groups and advise such groups on: Gilead policies, practices, procedures, and regulatory requirements Gilead systems (electronic Quality Management System) and other tools for managing quality items. Activities required in the RDQ function such as participating in vendor quality tasks, quality event tasks, quality metrics, quality systems, and audit tasks. Regulatory and Gilead requirements for regulatory inspections and responses to regulatory agency inquiries
• May support internal R&D for assigned R&D groups or locations. Conducts inspection and all RDQ related activities, such as managing participating in vendor quality tasks, quality event tasks, quality metrics, quality systems, and audit tasks.
• May provide R&D Quality support for inspections and quality management administrative and systems support, such as: Managing, tracking and reporting on R&D quality inspections, vendor quality tasks, quality event tasks, quality metrics, quality systems, and audit tasks. Providing systems and reporting training to others Performing quality checks on data and reporting to ensure accuracy, completeness and compliance Supporting administrative coordination, scheduling and reporting related to R&D Quality inspections
• Participates in continuous improvements to R&D vendor quality audits, inspections and CAPA management processes, policies, procedures, practices and tools.
• May 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.

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level