Director, GCP Quality Assurance and Inspection Readiness

Intellia•Cambridge, MA

15h•$213,063 - $260,411•Remote

About The Position

The Director, GCP Quality Assurance will serve as a strategic leader in the R&D Quality organization. This role will be responsible for ensuring global GCP compliance (e.g., FDA, EMA, ICH etc.) while providing guidance on clinical trial operations and fostering a culture of quality and compliance focused on patient safety. The individual will partner closely with other cross-functional groups to develop a quality strategy supporting Intellia’s pipeline while ensuring inspection readiness at all times. A demonstrated ability to think outside of the box with a pragmatic risk-based approach for quality management is essential to this role. The candidate should be willing to roll up their sleeves and directly contribute to the implementation of processes and resolution of issues as required. Position may require up to 15% domestic/international travel.

Requirements

Previous experience with direct responsibility for inspection readiness
Experience in supporting health authority inspections
Ability to function well in a high-paced and at times stressful environment.
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
Investigation, Root Cause Analysis, CAPA and Effectiveness check processes, tools, and techniques
Risk management principles and process, change management
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
A strong team player with great interpersonal and written communication skills
Ability to prioritize tasks and to delegate them when appropriate.
Strong problem solving and critical thinking skills, required to make sound decisions.
Demonstrated strength in analytical and strategic assessment of regulatory compliance risks and the ability to articulate potential business impact.
Highly self-motivated, well-organized, and confident, with a solution-oriented mindset.
Able to develop innovative solutions to issues.
Ability to influence people at different levels and negotiate cross-functionally in a matrix organization to resolve conflicts.
Ability to build and sustain meaningful relationships with business stakeholders and partners
Highly self-motivated, well-organized, and confident, with a solution-oriented mindset.
Able to develop innovative solutions to issues.
Ability to influence people at different levels and negotiate cross-functionally in a matrix organization to resolve conflicts.
Ability to build and sustain meaningful relationships with business stakeholders and partners
M.S. (or equivalent degree) and 12+ years of relevant work experience, or B.S. in a scientific or allied health field and 15+ years of relevant experience
A minimum of 10 years of experience in a GCP related discipline.
Expert knowledge of global GCP requirements and applicable drug development regulations, including USA (FDA), EU (EMA, MHRA), and ICH Guidelines.
Demonstrated strength in analytical and strategic assessment of regulatory compliance risks and the ability to articulate potential business impact.
Prolonged periods of sitting at a desk and working on a computer.

Responsibilities

Proactively provide consultative GCP QA support to Clinical Development activities to protect patient safety, maintain data integrity, and support operational efficiency.
Assure global regulations are followed for clinical trial / product reporting, including submission of adverse events/SAE reporting and all required clinical reports.
Assist in the implementation of GCP compliant procedures and operations to ensure a robust quality management system for the conduct of clinical studies and marketed pharmaceutical/medical device combination products.
Actively manage inspection readiness activities. Support health authority inspections of clinical sites, vendors and Intellia as needed.
As a strategic partner, serve as a resource to global clinical and safety personnel on compliance issues, risk management activities, preparations for external inspections, regulatory risk, and process improvement opportunities and develop and oversee appropriate Quality metrics and reporting on the state of Intellia’s compliance to senior management regarding critical quality and compliance related issues and corrective actions to mitigate risk.
Deliver leadership and technical direction in preparation and hosting of Health Authority Inspections internally, at clinical sites, and at CROs, including follow-up efforts, to ensure successful outcomes and responses to any observations.
Manage CQA staff, including recruitment, performance management, hiring, training and development
Sit on the R&D Quality Leadership team.
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.