Sr Compliance Specialist, Quality Management System Compliance

职位描述

Kite is seeking an Sr. Compliance Specialist, Quality Management System Compliance, to join our Research and Development Quality Medical Governance team (R&D Q&MG). The position will report into the Sr. Director, R&D Quality and Medical Governance. This role is responsible for providing quality metrics reports for the R&D Q&MG organization, supporting quality and compliance oversight of laboratory systems used in R&D for Good Clinical Laboratory Practice (GCLP), assisting with quality events and CAPA oversight, and supporting Kite’s electronic Quality Management System (eQMS) system. You will have an opportunity to grow and develop by partnering closely with our R&D Q&MG team and learning various aspects and roles within a quality organization.

In this role you will be responsible for providing accurate and concise metrics for leadership review, helping to assure that Kite’s laboratory systems are validated and follow current regulations, ensuring data integrity requirements, and conducting gap assessments on current processes. You will have an opportunity to work with an expert team and develop your skillset in a Quality organization. This role will require attention to detail and will help develop your relationship building skills and the ability to influence and negotiate with cross-functional stakeholders primarily within the R&D organization. You will be a part of an experienced professional global Quality leadership team that strives to be a trusted business partner and promotes a culture of Quality across the R&D organization.

This role is based out of our Santa Monica, CA location.

Primary Responsibilities:

• Generation of clear, accurate, and concise metrics for functional partners and management review
• Assist with Laboratory Systems Compliance and providing quality guidance on qualification of new analytical instruments, including computerized systems and assessments of existing instruments/systems
• Assist with supporting deviation identification, reporting, CAPA development and oversight, effectiveness check management
• Assist in supporting Computer System Validation QA team
• Foster a commitment to quality in cross functional team members and stakeholders as well as a culture of quality within the organization
• Participate in inspection preparation and management, and directly support regulatory agency inspections
• Assist in coordination of response to any inspection findings
• Keeps a watch toward changes in industry/regulatory environment that would necessitate future changes and proactively initiates discussions, so the company is prepared to respond to such changes
• Represent R&D Quality and Medical Governance in internal and external meetings

NOTE: If the candidate does not have all attributes above, they will be trained on the areas to develop the necessary skillset.

Basic Qualifications:

• Advanced scientific degree (i.e. MD, PharmD, PhD) and relevant experience - OR -
• Master’s Degree and 3+ years of relevant experience - OR -
• Bachelor’s Degree and 5+ years of relevant experience

Preferred Qualifications

• Understanding of GCP and GCLP
• Knowledge of ICH E6 R2, 21 CFR Part 11, and data integrity requirements
• Experience working cross-functionally within an R&D organization
• Experience with deviation and CAPA management teams
• Understanding of the software development lifecycle (SDLC) is a plus
• Experience with auditing and regulatory inspections is a plus
• Excellent verbal and written communication skills and interpersonal skills
• Proficient in Microsoft Office suite
• Experience working with Tableau
• Excellent organization skills and project management
• Able to work equally well as part of a team or independently
• Adaptable and comfortable in a collaborative and inclusive company environment
• Creative and thoughtful problem-solving skills
• Ability to travel approximately 10% required