Director, Quality and Enterprise Risk Management

Gilead Sciences, Inc.; California (MO); On-site; USD 191,000 - 248,000; Full time

Job summary

An established industry player is seeking a visionary Director for Quality and Enterprise Risk Management. This pivotal role involves leading risk management strategies and ensuring compliance with regulatory standards in the biopharmaceutical sector. The ideal candidate will develop and implement comprehensive quality risk management frameworks, driving continuous improvement initiatives and fostering a proactive culture. With a focus on collaboration, the Director will integrate quality and enterprise risk management practices across the organization, ensuring alignment with industry regulations. Join this innovative firm to help shape the future of cancer therapies and empower teams to excel in a dynamic environment.

Benefits

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Medical insurance

Dental insurance

Vision insurance

Life insurance

Qualifications

• 8+ years in quality and enterprise risk management within biopharmaceuticals.
• Experience with GMPs, ICH Q9, and FDA regulations.
• Proven success in developing QRM and ERM frameworks.

Responsibilities

• Develop and maintain ERM and QRM programs in compliance with regulations.
• Lead risk assessments and develop mitigation strategies.
• Design training programs to promote risk awareness.

Skills

Analytical Skills

Communication Skills

Team Building

Risk Management

Quality Management

Regulatory Compliance

Education

PhD in a scientific discipline

Master’s degree in a scientific discipline

Bachelor’s degree in a scientific discipline

Tools

FMEA

HACCP

PHA

Job description

Director, Quality and Enterprise Risk Management

Director, Quality and Enterprise Risk Management

United States - Maryland - Frederick, United States - California - Santa Monica, United States - California - Oceanside Quality Regular

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

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

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.

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.

#LI-ML1

#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*.

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

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.

#LI-ML1

#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:

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 www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma .

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Please apply via the Internal Career Opportunities portal in Workday.

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Job Requisition ID R0045235

Full Time/Part Time Full-Time

Job Level Director

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