Sr. Director, R&D Quality and Compliance

Role Summary

The Senior Director of R&D Quality Assurance is responsible for establishing and implementing the strategy for the R&D QA function that provides Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Laboratory Practices (GLP), and Research quality oversight at Intellia Therapeutics.

Responsibilities

• 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 to ensure implementation of quality and compliance initiatives for global Phase I - IV clinical studies, including establishment and maintenance of phase appropriate quality systems for cell and gene therapy products.
• Partner cross functionally to enable transparency & escalation of R&D quality risks and issues, collaborating to address challenges and constraints. Provide risk-based rationale to facilitate decision-making, demonstrate sound judgment, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks
• Establish strong partnership with senior leaders and key stakeholders, fostering a commitment to quality and a culture of quality. Interface with key external Quality organizations for development vendors and partners.
• Collaborate with Research leadership and other key business partners to develop and drive research quality practices that assure Research studies are conducted and data collected in compliance with approved experimental plans and/or protocols, appropriate Corporate guidelines, internal procedures, domestic and global regulatory guidelines and standards.
• Identify and drive continuous quality process improvements through assessment of audit, inspection and quality event outcomes and identification of trends from internal deviations.
• Assist in the implementation of compliant procedures and operations to ensure a robust quality management system for the conduct of clinical studies and marketed products.
• Serve as a resource to global clinical and safety personnel on compliance issues, preparations for external inspections, regulatory risk, and process improvement opportunities. Provide guidance and training on relevant GxP regulations and guidelines to cross-functional business partners.
• Review regulatory and corporate compliance risks, altering senior management when needed.
• Assure global regulations are followed for clinical trial reporting, including submission of adverse events/SAE reporting and all required clinical reports.
• Assure personnel, documentation (protocols, reports), processes and quality standards meet expectations for regulatory submissions, regulatory authority inspections, and compliance with applicable regulations and guidelines.
• Develop and oversee appropriate Quality metrics and reporting on the state of Intellia Therapeutics' compliance to senior management regarding critical quality and compliance related issues and corrective actions to mitigate risk.
• Assure the quality and integrity of the results from raw data protocols and reports are in compliance with investigational plans, policies, procedures, and applicable government regulations.
• Deliver leadership and technical direction in preparation and hosting of Health Authority Inspections (e.g. BIMO, MHRA, EMA) internally, at clinical sites, and at CROs, including follow-up efforts, to ensure successful outcomes and responses to any observations.
• Host GCP and GVP regulatory inspections at Intellia Therapeutics. Lead/oversee management of internal inspection readiness activities throughout program life cycle for study teams
• Direct the internal and external R&D audit programs, including the development of audit plans, priorities and schedules.
• In collaboration with functional area leaders, ensure clinical and pharmacovigilance service providers comply with the applicable quality program and regulations/guidelines.
• Oversee the development and implementation of Study-Specific Audit Plans and Quality Risk Management Plans for clinical trials.
• Oversee R&D QA incident investigations, including input and approval of plans for resolution of Quality issues including but not limited to the assessment of serious breaches, partnering with internal and external stakeholders to ensure CAPAs are appropriate and effective.
• Proactively provide consultative R&D QA support to global clinical development activities to protect patient safety, maintain data integrity, and support operational efficiency.
• Function as a member of the Quality Leadership Team (QLT), responsible for establishing the organizational strategy, resource and capacity planning, culture building, talent management, and stakeholder engagement.
• Build strong R&D QA team. Manage and develop staff through empowering team members.
• Develops and manages the annual R&D Quality budget.
• Recruits, interviews, hires, and trains new staff.
• Oversees the daily workflow of the department.
• Provides constructive and timely performance evaluations.
• Proven ability to build and manage a high performing group, including attracting, retaining and coaching top talent
• Handles discipline and termination of employees in accordance with company policy.

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, pharmacovigilance, product surveillance for cell and gene therapies
• Expert knowledge of global GCP regulations (US/EU etc.); ICHE6, 21 CFR Part 50, 54, 56, 312, 314, and high-level knowledge of 21 CFR Part 11 and International equivalents as necessary
• Experience implementing and ensuring GCP/GVP/GLP quality (e.g., GCP oversight, auditing, electronic systems management, global inspection readiness.)
• Experience leading/hosting regulatory authority inspections and developing responses to regulatory authority inspection findings.
• Proven experience in successfully developing and implementing Quality Risk Management Plans for clinical trials and safety.
• Experience working with CROs, vendors, and relationship management.
• Demonstrated strategic planning and execution skills required.
• Proven ability to design/evolve and /or implement Quality Management Systems in a fit-for-purpose manner enabling effectiveness, flexibility, and adaptability in a dynamic and evolving business model.
• Current knowledge of industry trends and best practices- for progressive quality management in a regulated environment.
• Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.

Education

• 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 with demonstrated ability to provide strategic direction using risk frameworks in to support development programs.
• Minimum 10 Years Team Leadership Experience.

Additional Requirements

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