Director, Quality and Enterprise Risk Management

职位描述

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.

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