Director, Quality and Enterprise Risk Management

Director, Quality and Enterprise Risk Management

Join to apply for the Director, Quality and Enterprise Risk Management role at Kite Pharma

Director, Quality and Enterprise Risk Management

Join to apply for the Director, Quality and Enterprise Risk Management role at Kite Pharma

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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
We are seeking an experienced and visionary Quality and Enterprise Risk Management (QRM/ERM) Director to lead our organization's risk management strategies, ensure compliance with regulatory standards, and create a robust Enterprise Risk Management (ERM) program. This role requires the development and implementation of comprehensive quality risk management frameworks, integrated seamlessly into the ERM system. The QRM/ERM Director will drive continuous improvement initiatives, mitigate risks, foster a proactive culture that aligns quality and enterprise risk management practices, and implement effective systems to enhance organizational resilience. This leadership position calls for a dynamic professional with exceptional analytical, communication, and team-building skills.
Job Responsibilities
Risk Management Frameworks:

• Develop, implement, and maintain a robust ERM program and QRM program in compliance with industry regulations, standards, and company policies.
• Integrate QRM principles into all quality systems per ICHQ10 framework to ensure alignment across all risk evaluation and mitigation strategies.
  

Risk Identification and Mitigation:

• Collaborate with senior leadership and cross-functional teams to identify, assess, and prioritize both quality and enterprise-level risks.
• Lead cross-functional teams to conduct risk assessments (e.g., FMEA, HACCP, PHA) and ensure timely resolution of identified risks.
• Develop effective mitigation strategies and implement control measures to address both current and emerging risks.
  

Collaboration and Integration:

• Partner with ERM stakeholders to establish metrics, dashboards, and reporting mechanisms for increased visibility of quality-related and enterprise risks.
• Coordinate with quality and operational teams to integrate QRM practices into all processes, ensuring a unified approach to risk management.
  

Continuous Improvement:

• Drive initiatives to improve quality systems, standardize risk-related processes, and strengthen compliance with regulatory requirements.
• Lead efforts to analyze trends, develop process improvements, and ensure the organization stays ahead of regulatory changes.
  

Governance and Oversight:

• Serve as a liaison between departments, senior leadership, and regulatory authorities during audits, inspections, and strategic discussions on risk-related matters.
• Define roles and responsibilities within the QRM/ERM framework to maintain organizational alignment.
  

Training and Awareness:

• Design and deliver training programs that promote a culture of risk awareness and enhance QRM/ERM competencies across the organization.
  

Regulatory Compliance and Reporting:

• Ensure compliance with global regulatory expectations, including FDA, EMA, and ICH guidelines (e.g., ICH Q9).
• Prepare and present risk reports to senior management, outlining key findings, trends, and actionable recommendations.
  

Basic Qualifications

• PhD degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering) with 8+ years of quality and enterprise risk management within the pharmaceutical or biopharmaceutical industry OR
• Master’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering) with 10+ years of quality and enterprise risk management within the pharmaceutical or biopharmaceutical industry OR
• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering) with 12+ years of quality and enterprise risk management within the pharmaceutical or biopharmaceutical industry OR
• Associate’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering) with 14+ years of quality and enterprise risk management within the pharmaceutical or biopharmaceutical industry OR
• High School Degree with 16+ years quality and enterprise risk management within the pharmaceutical or biopharmaceutical industry.
  

Preferred Qualifications

• Advanced degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering).
• Minimum 10 years of experience in quality and enterprise risk management within the pharmaceutical or biopharmaceutical industry.
• Deep knowledge of GMPs, ICH Q9(R1), EU GMP, FDA regulations, and global quality systems in regulated industries.
• Proven experience in developing and integrating QRM and ERM frameworks.
• Strong familiarity with tools and methodologies like FMEA, HACCP, and PHA.
• Exceptional analytical, problem-solving, and decision-making capabilities.
• Strong leadership, interpersonal, and communication skills to inspire and guide diverse teams.
• Certification in quality or enterprise risk management (e.g., RIMS-CRMP, ASQ Certified Quality Risk Manager).
• Experience with advanced therapies (e.g., cell and gene therapy).
• Proven success in standardizing and improving QRM/ERM processes in fast-paced environments.
• Familiarity with digital tools for risk modeling, data analytics, and resource allocation.
  

The work you do at Kite will help change how cancer is treated and ensure patients and their families have more time together. Ready to create more tomorrows with us? Hit apply.
#IND123
The salary range for this position is: $191,250.00 - $247,500.00. 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:
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 Sign up to follow @KitePharma on Twitter at jobs in the United States:
Gilead Sciences Inc. 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 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
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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.
Gilead 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.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

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