Director, R&D Quality

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

EXAMPLE RESPONSIBILITIES:

• Accountable for the effective management, execution and oversight of R&D quality audits, inspection readiness, inspection preparation and conduct, CAPA management, quality event oversight and related deliverables for assigned R&D groups, regional affiliates, countries or workstreams, with emphasis on Asia-Pacific activities. 

• May act as a standing member of the R&D Quality Audits, Inspections and CAPA Management Leadership Team and contribute to development of short- and long-range strategy, infrastructure, resource plans, governance and process improvement across R&D Quality. 

• Typically leads and manages direct reports and/or provides matrixed leadership to project, audit, inspection, quality event and CAPA teams. Where applicable, hires, develops and retains diverse top talent, sets clear and elevating goals, and coaches direct reports on performance, development and career interests. 

• Leads all designated operational, managerial and administrative activities within R&D Quality Audits, Inspections, CAPA Management and regional quality oversight. 

R&D Quality Regional Oversight, Strategy & Stakeholder Support: 

• Acts as a primary point-of-contact to assigned R&D groups, study teams, affiliates and regional stakeholders and advises on Gilead/Kite and regulatory requirements for R&D quality, including global, regional and local expectations. 

• Provides R&D Quality oversight for Japan clinical trial activities, including Japan-specific clinical trial execution considerations, PMDA inspection readiness, local regulatory expectations such as J-GCP, and coordination with Japan-based clinical, regulatory and quality stakeholders. 

• Supports clinical trial related activities associated with Global expansion for Kite clinical trials by ensuring early quality strategy, risk assessment, governance, quality event management and inspection-readiness planning are built into expansion activities from the outset. 

• Partners with Clinical Operations, Regulatory Affairs, Patient Safety, Clinical Development, Data Management, Medical Affairs, vendors, affiliates and external partners to drive timely, risk-based and procedurally aligned quality decisions and issue resolution. 

• Provides guidance to study teams and functional areas on quality incidents, deviations, potential deviations, major and critical quality events, CAPAs, effectiveness checks, audit findings, escalation expectations and documentation standards. 

Inspection Readiness, Preparation, Conduct & Close-out: 

• May serve as business process owner or regional subject matter expert for inspection management activities within R&D. 

• Supports global and regional Gilead/Kite R&D inspection readiness in partnership with Quality Business Partners and functional area leads by advising on practices, procedures, systems, tools, storyboards, playbooks, responsibility matrices and inspection preparation expectations. 

• Collaborates and proactively engages cross-functionally to gather and analyze risks, establish mitigations, support remediation and ensure inspection deliverables are consistent, accurate and defensible. 

• Prepares and leads training of R&D personnel on inspection readiness, dossier collation, interview preparation, regulatory agency inquiry response, conduct during inspections and post-inspection commitments. 

• Leads and/or advises Subject Matter Experts on responses to regulatory agency inquiries and inspections, including coordination of a united company response with Inspection Leads, Inspection Sponsors and executive stakeholders as appropriate. 

• Analyzes, consolidates and integrates prior Gilead/Kite inspection experience, external intelligence, regulatory trends and lessons learned to shape proactive inspection strategy and regional preparedness. 

• Coordinates inspection management horizon scanning, tracking, archiving, close-out, Veeva QMS record development, action plan oversight and commitment follow-up for inspection findings and commitments. 

• Contributes to metrics generation and analysis across inspections to identify emerging trends, potential risks and opportunities for inclusion in Quality Management Review or other governance forums. 

Audits, CAPA Management, Quality Events & QMS Oversight: 

• Leads internal R&D quality audits for assigned R&D groups, programs, vendors, countries or locations, including audit planning, execution, reporting, follow-up and integration of lessons learned into the annual and quarterly audit program. 

• Establishes relationships and agreements with contract auditors, provides oversight and directs the work of contractor auditors where applicable. 

• Develops, reviews or advises on CAPAs and effectiveness checks as needed by collaborating cross-functionally to ensure appropriate root cause analysis, risk assessment, corrective/preventive actions, objective evidence and timely closure. 

• Provides regional oversight for major and critical quality events, including escalation, functional area approver engagement, stakeholder alignment, regulatory sensitivity assessment, patient safety/data integrity/business risk evaluation and recurrence risk considerations. 

• Evaluates SOPs, other procedures, systems, data, reporting and documentation of assigned R&D groups/locations to ensure ongoing regulatory compliance, R&D quality, operational effectiveness and fit-for-purpose alignment with business needs and changing regulatory requirements. 

• Leads continuous improvements to R&D quality audits, inspections, quality event, deviation and CAPA management processes, policies, procedures, practices, standards and tools. 

• Provides accurate and thorough input and recommendations into resource plans required to complete deliverables and tracks resources to ensure compliance with agreed priorities, budgets and timelines. 

GxP Regulatory Compliance, Intelligence & Change Management: 

• Supports development and execution of a GxP compliance intelligence and change management framework with emphasis on regional Health Authority expectations, including PMDA, NMPA and other applicable Asia-Pacific authorities. 

• Mines, analyzes, evaluates and escalates potential risks associated with emerging intelligence, regulatory changes, inspection observations, QMS trends and external health authority expectations. 

• Plays a lead role in preparing assigned R&D groups/locations for changes to regulations or other requirements and associated continuous improvement initiatives. 

• Develops and delivers GxP training for assigned R&D groups, including role-specific training related to audit readiness, inspection readiness, quality event management, CAPA expectations, QMS requirements, ICH E6(R3) risk-based quality principles and applicable regional regulations. 

• Contributes to external engagement, knowledge management and benchmarking activities to monitor development-stage GxP compliance expectations and strengthen Gilead/Kite’s collective voice in quality and compliance. 

Leadership: 

• Provides collaborative matrixed leadership to study teams, project teams, audit teams, inspection teams, quality event teams and regional stakeholders. 

• Contributes to strategic quality governance, trend review, continuous improvement and executive-level communication across the R&D Quality Management System. 

• Ensures own work, and that of direct reports where applicable, complies with established practices, policies, procedures, systems and applicable regulatory or local requirements. 

• Fosters a commitment to quality in individuals and a culture of quality across Gilead/Kite R&D, affiliates, regional partners and R&D vendors. 

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Education & Experience

• PharmD/PhD with 8+ years’ relevant experience.

• MA/MS/MBA with 10+ years’ relevant experience.

• BA/BS with 12+ years’ relevant experience.

• Significant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation, and continuous improvement.

• Significant experience in inspection management in the biopharma industry.

• Proven track record of effective people leadership and management, as evidenced through past effectiveness with employee engagement, development and retention either with direct reports or through matrix leadership responsibilities.

• Line management (direct reports) experience preferred.

• Track record of cultivating and maintaining strategic relationships and collaborations both internally and externally.

• Experience participating or leading external consortiums, trade associations, professional bodies or industry groups.

• Proven track record of successfully managing large scale, complex, time-sensitive projects.

• Hands on experience leading cross-functional process improvement initiatives with measurable outcomes.

Knowledge & Other Requirements

• Significant knowledge of the biopharma industry, as evidenced by proven track record in setting short- and long-range strategies and plans. 

• Expert knowledge of the drug development process and ICH E6 R3 requirements, including clinical studies, post-marketing/pharmacovigilance, laboratories and worldwide regulations as applied to cross-functional drug development. 

• Expert knowledge of GCP and strong working knowledge of regional Health Authority expectations, including PMDA, NMPA, J-GCP, ICH E6(R3) risk-based quality principles and other applicable local regulations. 

• Recognized as a QMS and quality risk management expert with thorough knowledge of standards, systems, policies and procedures that enable QMS operations and compliance within the biopharma GxP environment. 

• Demonstrates advanced strategic, business and analytical skills, with strengths in assessing complex information and understanding quality, patient safety, data integrity, regulatory, business and recurrence-risk implications. 

• Proven abilities to anticipate problems of varying complexity and lead, and if necessary negotiate, resolution in a collaborative manner across functions, geographies and leadership levels. 

• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects, initiatives, inspections, audits and quality governance forums. 

• Strong interpersonal skills and understanding of team dynamics, enabling negotiation, conflict resolution, stakeholder alignment and executive-level communication. 

• Strong communication and organizational skills. Demonstrable ability to effectively communicate project direction, quality risks, decision rationale and status to varying organizational levels, including leadership teams, executives and steering committees. 

• Strong coaching capabilities to mentor and develop staff and matrixed team members. 

• When needed, ability to travel domestically and internationally. 

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
 

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.