Sr. Manager, R&D Quality

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.
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
 

Position 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.

Position Overview:

Kite Pharma, Inc., a Gilead Company, is seeking a Senior Manager to join R&D Quality in Japan for audits and CAPA management. This position is located in the Gilead Sciences K.K. office in Tokyo, JP. R&D Quality Japan is a part of Kite Global R&D Quality headquartered in Santa Monica, CA, USA. 

Kite R&D Quality Japan provides quality oversight on GCP, GVP and GCLP activities through effectively managing the Japan audit program, CAPAs, and assisting the Japan study team with guidance and consult.

You will act as the primary point-of-contact for Kite products and Japan study teams. You will report to the Senior Director, R&D Quality (Global). You will plan, perform and coordinate internal and external GCP, GVP and GCLP audits as assigned in accordance with the annual audit program. You will manage CAPAs by collaborating cross-functionally with R&D functions to comply with regulatory requirements, Gilead's Quality Management System and related policies and procedures for Cell Therapy related products. You will provide guidance and consult to Japan study teams to ensure compliance with regulations, data integrity, and ensure patient safety and rights are protected. You will also have the opportunity to support the Kite R&D Quality team with PMDA inspections and Tokyo Metropolitan Government inspections, etc.
 

Job Responsibilities:

• Acts as a point-of-contact for internal R&D stakeholders and advises on:
  • Regulatory requirements in GCP, GVP and GCLP
  • Gilead/Kite policies, practices, procedures, systems and other tools
  • Activities required to address quality incidents or deviations, including specific advice on appropriate corrective and preventative actions (CAPAs)
• Performs and/or coordinates  audits in GCP, GVP and GCLP in cell therapy according to the annual audit plan, including investigator site audits, internal audits, vendor audits and partner audits. Write audit reports accurately and concisely, and review audit reports written by other auditors. Evaluate responses from auditees to audit observations.
• Establishes relationships and agreements with contract auditors, provides oversight and directs the work of contractor auditors, as needed. This includes contract management, maintenance of their training status on Gilead/Kite audit procedures, coordination of individual audits and review of audit reports.
• Participate in conducting risk assessments for Kite studies & vendors.
• Manages CAPAs deriving from R&D functions in Japan and R&D vendors in Japan.
• Evaluates SOPs and other procedures pertaining to GCP, GVP and GCLP to ensure ongoing regulatory compliance and Kite business needs.
• Plays a lead role in preparing R&D organization for changes to regulations or other requirements and/or continuous improvement initiatives.
• Develops and delivers GxP training for the R&D organization.
• Leads continuous improvements to R&D quality audits, CAPA management processes, policies, procedures, practices and tools.
• Fosters a commitment to quality in individuals and a culture of quality across Gilead/Kite R&D and with R&D vendors.
• Supports Gilead R&D Quality in Japan with inspections and/or audits, when needed.
• Perform other duties as assigned

Minimum Education and Basic Qualifications:

• Master’s degree in life sciences with 6+ years of relevant work experience in the pharmaceutical quality control, quality assurance or compliance environment.

• Bachelor’s degree in life sciences with 8+ years of relevant work experience in the pharmaceutical quality control, quality assurance or compliance environment.

Preferred Qualifications:

• Auditing and CAPA development experience in the biopharma or related industry.
• Significant experience working with GxP processes and systems in the biopharma or related industry is strongly preferred.
• Significant experience leading quality, compliance or related projects in the biopharma or related industry, including leading continuous improvements such as new or updated business processes, systems and/or SOPs is preferred.
• Experience providing guidance and consult to Japan study teams.
• Experience working with total quality management methodologies.
• Experience working in cell therapy is a plus.
• Certification as a Quality Auditor 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.
• Recognized as a GCP and GVP expert. GCLP knowledge is a plus.
• PMDA/inspection experience is a plus, but not required.
• Business English proficiency both for written and verbal communication as equivalent to TOEIC score >800.
• Advanced knowledge of the drug development process and understanding of and appropriate application of principles, concepts, practices, and cross-disciplinary GxP standards, as evidenced by ability to independently identify potential quality and compliance issues and recommend appropriate remediations.
• Demonstrates ability to analyze and resolve complex problems collaboratively with cross-functional colleagues, including ability to assess GxP processes and systems and understand the quality and compliance implications.
• Strong analytical thinking skills and attention-to-detail, as evidenced by the ability to effectively assess complex systems and data and accurately determine the quality and compliance implications.
• Strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through abilities to assume assignments and projects with increasing independence.
• Ability to lead and influence programs, projects and/or initiatives.
• Strong interpersonal skills and understanding of team dynamics.
• Proven ability to work successfully in a team-oriented, highly - matrixed environment.
• When needed, ability to travel.

People Leader Accountabilities

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

Equal Opportunities
As an equal opportunity employer, Gilead Sciences 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 laws. It is also Gilead’s policy to comply with all applicable laws respecting consideration of unemployment status in making hiring decisions.

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If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead

About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.