- Accountable for leading day to day QA compliance operation in conformance with Intellia's policies and procedures.
- Responsible for QA oversight as it relates to the QMS throughout the product lifecycle.
- Lead continuous improvement initiative to enhance the QMS.
- Lead the Quality Management Review and oversee trending of key quality management system performance metrics.
- Develop, review, and approve standard operating procedures and other controlled documents as needed.
- Collaborate with stakeholders to identify, define and implement opportunities for improved QMS process workflows.
- Ensure Deviations are initiated, investigated and resolved in accordance with established timelines and CAPAs are initiated and completed within a proper timeframe.
- Ensure timely closure of Quality Records such as change controls.
- Support activities to maintain a state of inspection readiness.
- Support internal and partner audits.
- Support and facilitate risk management activities.
- Identify and escalate issues to appropriate levels of management for resolution, as appropriate.
- Minimum of BS/BA Life sciences or related field
- 10+ years of experience in Cell and Gene, biologics, pharmaceutical, medical device, or related industry.
- 5+ years prior management experience with experience in building a team from the ground up.
- Proficiency with Veeva Systems.
- Any combination of education and experience will be considered.
- Prior experience with quality management and oversight of GLP/GMP/GCP operations from an outsourced and insourced business model is highly desirable.
- Extensive knowledge and experience of FDA/EMA regulatory requirements and expectations for operational compliance with GMP and GCP.
- Extensive experience/expertise in effectively managing deviations, CAPA, change control, and product complaints to meet regulatory expectations while adhering to assigned timelines.
- Experience with Risk Management program and its framework.
- Strong ability to communicate effectively with all levels of the organization within and outside of the department, including external vendors.
- Excellent organizational skills, analytical and problem-solving abilities, and strong verbal and writing skills.
- Ability to lead, motivate, and educate others on matters of quality compliance. Able to communicate the meaningful rationale behind Intellia quality requirements to promote a culture of quality awareness and appreciation for the value of quality compliance to the Intellia organization and the patients enrolled in Intellia clinical studies.
- Able to operate in a dynamic, fast-growing biotech company with aggressive timelines.
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Associate Director, Quality Systems Compliance - Cambridge, United States - Intellia Therapeutics, Inc.
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 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:
This position is the Associate Director of Quality Systems Compliance role to provide leadership and compliance oversight for Intellia's quality management system.
This position will report to the Director of Quality Systems and Compliance and is part of a growing compliance group. This position will start as an individual contributor but may have reports in the future.
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.
