[Hiring] Senior Director, R&D Quality and Compliance @Intellia Therapeutics, Inc.

Role Description

We are seeking a strategic and hands-on Senior Director, Good Clinical Practices (GCP) to serve as the enterprise leader responsible for establishing, implementing, and leading a comprehensive global GCP quality framework across Intellia Therapeutics' active clinical development portfolio. This role will drive the design and continuous evolution of a modern, risk-based, and inspection-ready GCP quality ecosystem that enables speed, compliance, and innovation.

• Provide overall R&D QA leadership and strategic development for global R&D QA activities at Intellia Therapeutics, its investigator sites, and external service providers.
• Partner cross-functionally to enable transparency & escalation of R&D quality risks and issues.
• Establish strong partnership with senior leaders and key stakeholders, fostering a commitment to quality and a culture of quality.
• Collaborate with Research leadership and other key business partners to develop and drive research quality practices.
• Identify and drive continuous quality process improvements through assessment of audit, inspection, and quality event outcomes.
• Assist in the implementation of compliant procedures and operations to ensure a robust quality management system.
• Serve as a resource to global clinical and safety personnel on compliance issues.
• Review regulatory and corporate compliance risks and escalate when warranted.
• Assure global regulations are followed for clinical trial reporting.
• Develop quality metrics and reporting systems to keep senior management informed of compliance status.
• Deliver leadership and technical direction in preparation and hosting of Health Authority Inspections.
• Direct the internal and external R&D audit programs.
• Oversee the development and implementation of Study-Specific Audit Plans and Quality Risk Management Plans.
• Proactively provide consultative R&D QA support to global clinical development activities.
• Collaborate as a Quality Leadership Team (QLT) member to establish strategic direction.
• Build a strong R&D QA team and manage and develop staff.
• Develop and manage the annual R&D Quality budget.

Qualifications

• Strong understanding of R&D Quality for pre-clinical, clinical, and commercial stage work.
• Expert knowledge and in-depth experience of implementation of global regulations in clinical trials.
• Expert knowledge of global GCP regulations (US/EU etc.); ICHE6, 21 CFR Part 50, 54, 56, 312, 314.
• Experience implementing and ensuring GCP/GLP quality.
• Experience leading/hosting regulatory authority inspections.
• Proven experience in successfully developing and implementing Quality Risk Management Plans.
• Experience working with CROs, vendors, and relationship management.
• Demonstrated strategic planning and execution skills.
• Proven ability to design/evolve and/or implement Quality Management Systems.
• Current knowledge of industry trends and best practices for progressive quality management.
• Excellent communication skills and a proven track record.
• M.S. (or equivalent degree) and 15+ years of relevant work experience, or B.S. in a scientific or allied health field and 17+ years of relevant experience.
• A minimum of 15 years of relevant GLP/GCP/GVP quality and compliance management experience.
• Minimum 10 years team leadership experience.

Requirements

• Prolonged periods of sitting at a desk and working on a computer.

Benefits

• Base salary expected to range between $259,676.00 - $317,382.00 USD per year.
• Performance-based annual cash bonus.
• New hire equity grant.
• Eligibility for annual equity awards.

EEOC Statement

Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.