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Manager, R&D Quality Audits,… at Gilead Sciences · Foster…
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Job Description
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
As the Manager, R&D Quality Audits, Inspections and CAPA, you will serve as a primary quality and compliance partner for assigned Kite R&D groups, studies, projects and locations. This role supports GCP and GVP quality oversight, internal and investigator site audit execution, inspection readiness, vendor audit awareness and CAPA management. You will partner cross-functionally with Kite stakeholders and Gilead RDQ teams to help ensure R&D activities remain compliant with applicable regulations, Kite’s Quality Management System, internal policies and established procedures.Key Responsibilities
Serve as a primary quality partner for assigned R&D GCP and GVP teams, providing guidance on regulatory expectations, Kite quality requirements, internal procedures, inspection readiness and CAPA development.
Lead or support internal R&D quality audits for assigned groups, processes, vendors or locations, including GCP-focused activities, investigator site audits, internal process audits and GVP-related audits as assigned.
Support vendor audit awareness and compliance oversight by partnering with cross-functional teams to understand vendor qualifications, performance trends, audit needs and study-level compliance risks.
Develop, track and support effective CAPAs in partnership with cross-functional stakeholders to address audit findings, inspection observations, deviations, quality events and other compliance risks.
Support inspection readiness activities, including preparation, coordination, response support and follow-up actions for regulatory or compliance inspections.
Evaluate SOPs, procedures, data, documentation and reporting for assigned R&D groups to help ensure regulatory compliance, quality oversight and alignment with business needs.
Oversee or coordinate contract auditor activities, including auditor engagement, work direction, documentation review and audit deliverable follow-up.
Advise teams on quality systems, processes, documentation, training and CAPA management to support consistent R&D quality practices.
Develop and deliver GCP and GVP-focused training for assigned R&D groups and stakeholders.
Lead or participate in continuous improvement initiatives related to R&D audits, inspections, CAPA processes, quality systems, policies, procedures and tools.
Support quality metrics, reporting and communications related to audit plans, audit outcomes, inspection readiness, CAPA status and quality trends.
May support task management, workload coordination or day-to-day guidance for other team members without direct people management responsibility.
Promote a culture of quality, accountability, collaboration and inspection readiness across Kite R&D and with external partners and vendors.
Ensure assigned work is completed in accordance with applicable regulations, established practices, policies, procedures and business processes. Basic Qualifications
PharmD or PhD with relevant quality and compliance experience; or
MA, MS or MBA with 4+ years of quality and compliance experience; or
BA or BS with 6+ years of quality and compliance experience. Preferred Qualifications
MA, MS or MBA with 4+ years of relevant quality and compliance experience preferred.
Strong GCP auditing experience, including experience serving as lead auditor for investigator site audits.
Experience supporting or leading internal process audits within GCP, R&D quality, clinical operations or related biopharma functions.
Experience supporting inspection readiness, inspection preparation, inspection response activities or inspection follow-up actions.
Vendor audit experience or strong working knowledge of vendor qualifications, vendor performance oversight and study-level vendor compliance expectations.
Quality, compliance, regulatory or related experience supporting pharmacovigilance, safety, medical affairs, clinical operations or other R&D functions, with strong experience in GCP and GVP.
Internal auditing and CAPA development experience within GCP, GVP, pharmacovigilance, safety or related biopharma functions.
Experience leading quality, compliance or related projects in the biopharma industry, including process improvements, system enhancements, SOP updates or quality initiatives.
Experience working with GCP and GVP processes, systems and quality expectations in a biopharma or related environment.
Experience with total quality management methodologies, such as Lean Six Sigma.
Experience supporting one or more Kite therapeutic areas and multiple stages of drug development.
Quality Auditor certification or similar quality-related certification. Knowledge and Other Requirements
Strong knowledge of Good Clinical Practices, Good Pharmacovigilance Practices, quality systems, safety reporting, inspection readiness and CAPA management.
Working knowledge of Good Clinical Laboratory Practices and Electronic Systems Compliance.
Ability to apply sound judgment and flexibility in GCP quality environments where risk evaluation may be situation-specific.
Strong analytical thinking, attention to detail, written communication and project management skills.
Ability to recognize urgency, escalate key quality or inspection-related issues appropriately and adapt priorities when inspection or compliance activities require immediate attention.
Ability to learn quickly, adapt to changing priorities and support multiple projects or business needs.
Ability to lead, influence and collaborate across programs, projects and cross-functional initiatives without direct authority.
Strong interpersonal skills and ability to work effectively in a highly matrixed, team-oriented environment with Kite and Gilead partners.
Transparency, flexibility, accountability and strong communication skills.
Proficiency with Microsoft Office applications.
Ability to travel globally as needed, estimated at approximately 30% to 40% depending on audit schedules, site availability and business needs.
The salary range for this position is: Bay Area: $136,340.00 - $176,440.00.
Other US Locations: $123,930.00 - $160,380.00.
Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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 http://www.kitepharma.com. Sign up to follow @KitePharma on Twitter at http://www.twitter.com/kitepharma.
For jobs in the United States:
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Kite Pharma Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.