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Form of workWhy Join Intellia?
Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.
Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.
We want all of our people to go beyond what is possible. We aren't constrained by typical end rails, and we aren't out to just "treat" people. We're all in this for something more. We're driven to cure and motivated for change. Just imagine the possibilities of what we can do together.
How you will Achieve More with Intellia:
As the Director of GCP/GVPVendor Quality & Audit Management, you will join the Intellia Therapeutics' Quality Assurance Organization where you will lead Vendor Quality & Audit activities related to GCP/GVP vendors/services, specifically external processes, including the oversight of Vendor/CRO audit activities across Intellia Therapeutics' GCP/GVP business functions. You will be responsible for the design and execution of risk-based approaches related to the audit of clinical and pharmacovigilance vendors supporting Intellia Therapeutics' development programs, assuring adherence to applicable regulations, industry standards, and to Intellia Therapeutics' policies, procedures and quality standards as outlined in the Quality Management System. The role also includes representation to interdepartmental teams advising teams on GCP/GVP Vendor Audit outcomes. This individual will own the development of Intellia Therapeutics' GCP/GVP audit schedules and plans across the development organization, building/advancing the risk-based approaches in partnership with QA and Business stakeholders and have budget responsibilities for the identification, qualification, and oversight of external audit organizations. Additional key responsibilities include:
About you:
Are you a motivated leader with organizational skills and drive? Our ideal candidate is someone with experience in risk-based Vendor Quality & Audit Management programs and who thrives in an environment with the ability to shape an evolving audit program in support of this expanding team with:
Position may require up to 20% domestic/international travel.
Meet your future team:
You will be joining a dynamic growing team who are passionate about quality and patient-centric. Intellia's quality group is a young organization that has grown quickly during the last two years to support previously contracted capabilities moving in-house. Joining our team, you will have the opportunity to advance the GCP/GVP Vendor Quality Management and Audit program. The continued rapid growth of the quality organization as well as the company means you will be in a fast-paced dynamic remote-friendly work environment with a team that knows how to support it.
Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.
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. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.
Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.
We want all of our people to go beyond what is possible. We aren't constrained by typical end rails, and we aren't out to just "treat" people. We're all in this for something more. We're driven to cure and motivated for change. Just imagine the possibilities of what we can do together.
How you will Achieve More with Intellia:
As the Director of GCP/GVPVendor Quality & Audit Management, you will join the Intellia Therapeutics' Quality Assurance Organization where you will lead Vendor Quality & Audit activities related to GCP/GVP vendors/services, specifically external processes, including the oversight of Vendor/CRO audit activities across Intellia Therapeutics' GCP/GVP business functions. You will be responsible for the design and execution of risk-based approaches related to the audit of clinical and pharmacovigilance vendors supporting Intellia Therapeutics' development programs, assuring adherence to applicable regulations, industry standards, and to Intellia Therapeutics' policies, procedures and quality standards as outlined in the Quality Management System. The role also includes representation to interdepartmental teams advising teams on GCP/GVP Vendor Audit outcomes. This individual will own the development of Intellia Therapeutics' GCP/GVP audit schedules and plans across the development organization, building/advancing the risk-based approaches in partnership with QA and Business stakeholders and have budget responsibilities for the identification, qualification, and oversight of external audit organizations. Additional key responsibilities include:
- Partners with functional and quality teams to define ongoing and pragmatic vendor oversight approaches for vendors based on risk and in establishing robust GCP/GVP-specific Vendor Quality performance metrics (e.g. KQIs) across contracted GCP/GVP activities
- Establishes strategy for periodic engagement with quality partners at vendors to drive improvement where required and to capitalize on opportunities for strategic quality-quality partnership.
- Serves as Lead of the GCP/GVP Vendor Quality Management/Audit function with responsibility for the overall strategic direction, performance, and effectiveness of the Vendor Quality oversight and audit program in assuring quality risk management/mitigation and the adequacy and adherence to controls for quality and compliance with GCP/GVP regulatory requirements (and guidances, etc.)
- Partners with quality and business stakeholders for coordination and alignment in ensuring the overall quality of audit and adequacy in remediation/improvement across vendors/CROs and internal operations (e.g. audit planning, review of audit outcomes, and corrective/preventive action development and implementation)
- Directs the development and maintenance of the integrated and risk-based GCP/GVP Audit Plan and provides leadership in setting the direction to plan development, execution and adherence. Partners with and engages stakeholders and leadership across business areas and QA in risk evaluation when determining the audit schedule
- Collaborates with other Quality Leaders to provide strategic direction and alignment of risk-based approaches, ensuring that GCP/GVP audit strategies and processes are established to:
- Enable the execution of GCP/GVP Vendor/CRO qualification and requalification audits
- Provide oversight, including budget forecast and tracking, for outsourced audits
- Execute directed or For-Cause audits, as needed
About you:
Are you a motivated leader with organizational skills and drive? Our ideal candidate is someone with experience in risk-based Vendor Quality & Audit Management programs and who thrives in an environment with the ability to shape an evolving audit program in support of this expanding team with:
- M.S. (or equivalent degree) and 7+ years of relevant work experience, or B.S. in a scientific or allied health field and 10+ years of relevant GCP/GVP QA audit/Vendor Quality management program development/maintenance and execution using risk frameworks in the regulatory compliance environment, or relevant comparable background.
- GCP/GVP Audit processes and Quality Systems
- 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
- Understands Phases I-IV of Drug Development and the pharmacovigilance requirements; and the lifecycle maintenance of drugs especially as they relate to Pharmacovigilance, including, QA oversight for pharmacovigilance activities (ICSR assessment and processing; aggregate safety reporting, Risk Management and REMS; Signal detection methodologies; Safety Review Committee activities and subsequent outcomes);
- Investigation, Root Cause Analysis, CAPA and Effectiveness check processes, tools, and techniques
- 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
Position may require up to 20% domestic/international travel.
Meet your future team:
You will be joining a dynamic growing team who are passionate about quality and patient-centric. Intellia's quality group is a young organization that has grown quickly during the last two years to support previously contracted capabilities moving in-house. Joining our team, you will have the opportunity to advance the GCP/GVP Vendor Quality Management and Audit program. The continued rapid growth of the quality organization as well as the company means you will be in a fast-paced dynamic remote-friendly work environment with a team that knows how to support it.
Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.
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. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
