- Support clinical study teams for assigned studies through attendance at study meetings, review of study documents, and consultation on GCP-related questions. Identify and escalate significant compliance issues to Clinical QA and other relevant leadership, including the assessment of serious breaches.
- Maintain high level of expertise in global GCP regulations and internal policies and procedures that impact clinical study conduct.
- Drives the strategies for Preparation, Support and Follow-up activities for Inspection Readiness
- Develop inspection preparedness plans for studies and/or programs, collaborating with stakeholders to prioritize activities using a risk-based approach,
- Support and monitor Inspection Readiness activities throughout trials and make recommendations for continuous improvement.
- Conduct and/or support external GCP audits of clinical vendors, investigator site audits and audits of clinical functions.
- Collaborate with stakeholders in conducting ongoing risk assessments of clinical study activity to identify priority studies, compliance metrics for tracking, high-risk service providers, and key Clinical QA activities (i.e., protocol review, service provider risk mitigations, inspection readiness).
- May participate in evaluation and selection of GCP service providers and development of Quality Agreements
- Establish relationship with CRO Quality Team members for the ongoing review of quality and compliance issues and identify and anticipate trends in quality issues, collaborate with department management to ensure risk-managed solutions are implemented in a timely fashion.
- May serve as GCP Quality Management System representative.
- Participates in collaborative review of impacted SOP/WI
- Reviews and analyzes key Performance Indicator data and trends
- Analyzes risk and proposes remedial, corrective and /or preventive actions
- May participate on process improvement initiatives
- Provides cross-functional support across Intellia Therapeutics' Quality Assurance team.
- Participate in quality and compliance initiatives, as assigned.
- Contribute to development and execution of department goals and objectives.
- May provide consultative PV QA support to Clinical Development activities and assist in the implementation of GVP compliant procedures and tools to protect patient safety, maintain data integrity, and support operational efficiency.Minimum qualifications:
- BS/MS degree in a related scientific field with 6-8 years, respectively, of relevant experience in the biopharmaceutical/pharmaceutical industry, or equivalent
- A minimum of 5 to 8 years of experience in a GCP related discipline. Prior experience as a CRA, Study Coordinator, or in clinical study management is strongly preferred.
- Experience in a GVP related discipline is preferred
- 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.
- 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.In-depth knowledge in the following areas:
- 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
- Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions.Covid-19 Vaccination Policy:All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.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.
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Associate Director, Clinical Quality Assurance - Cambridge, United States - Intellia Therapeutics
Description
Why 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 wantall ofour 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.
Title/Role: Associate Director, Clinical Quality Assurance
Area: Quality Assurance
General position summary:
The Associate Director (AD), Clinical Quality Assurance will provide GCP compliance oversight and support to the Intellia Therapeutics Clinical Organization and clinical study teams. The key activity of the role is providing expertise and guidance regarding applicable Good Clinical Practice regulatory requirements, and Intellia Therapeutics' Standard Operating Procedure requirements for the conduct of clinical studies.
As a GCP compliance expert, the Associate Director (AD) of Clinical Quality Assurance will utilize a risk-based and phase-appropriate strategy to prioritize GCP QA support for clinical trial activities, identify and escalate compliance issues, enable proactive decision making, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks. In addition, the AD of Clinical Quality Assurance will partner with Clinical Operations, Clinical Development, Regulatory, Safety and other key functions to enable transparency and escalation of quality and compliance matters.
The AD of Clinical Quality Assurance will actively contribute to the development, maintenance, and implementation of GCP-related policies, SOPs and other procedural documentation. This role will participate in the management of systems relevant to the administration of the Clinical QMS in support of regulatory requirements for application in drug development and clinical trial execution within the Intellia Clinical Organization. Participation in GCP auditing activities may also be assigned based on experience. This position reports to the Director, GCP/GVP Quality.
Position may require up to 15% domestic/international travel.
Key Responsibilities:
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