Director, Quality and Enterprise Risk Management

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR Tcell therapies have changed the paradigm. But were 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 organizations 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 teambuilding 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 crossfunctional teams to identify assess and prioritize both quality and enterpriselevel risks.

• Lead crossfunctional 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 qualityrelated 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 riskrelated 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 riskrelated 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 8years of quality and enterprise risk management within the pharmaceutical or biopharmaceutical industry OR

• Masters degree in a scientific discipline (e.g. Chemistry Biology Pharmacy Engineering) with 10years of quality and enterprise risk management within the pharmaceutical or biopharmaceutical industry OR

• Bachelors degree in a scientific discipline (e.g. Chemistry Biology Pharmacy Engineering) with 12years of quality and enterprise risk management within the pharmaceutical or biopharmaceutical industry OR

• Associates degree in a scientific discipline (e.g. Chemistry Biology Pharmacy Engineering) with 14years of quality and enterprise risk management within the pharmaceutical or biopharmaceutical industry OR

• High School Degree with 16 yearsquality 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 problemsolving and decisionmaking capabilities.

• Strong leadership interpersonal and communication skills to inspire and guide diverse teams.

• Certification in quality or enterprise risk management (e.g. RIMSCRMP 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 fastpaced 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.

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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 longterm 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 systems 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:

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