VP Head of Quality
- Employer
- Intellia Therapeutics
- Location
- Cambridge, MA
- Start date
- Nov 18, 2021
View more
- Discipline
- Quality, Quality Control
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
- Hotbed
- Genetown
Job Details
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:
As Intellia’s Head of Quality you will lead and evolve the Quality function which currently includes Quality Assurance, Quality Control, Clinical Quality and Supplier Quality.
In this role, you will:
Ensure global regulatory and industry standards are met
Set the Quality vision for the company
Build the organization to deliver quality systems and direct quality operations
Develop and maintain the Quality Management System and associated Quality processes and procedures to support all GXP operations.
Provide regular updates to the executive team on corporate Quality status, active initiatives, and Quality metrics
Collaborate with and educate internal and external partners to implement a culture of Quality
Use risk-based, science-based logic in decision making
Develop and deliver Quality functional goals aligned with corporate strategy and operations, quality risk assessment and mitigation.
Provide strategic insight to annual, long-range planning and budgetary processes. Construct budgets and manage to deliver on budget
Identify, hire, manage and develop experienced Quality leaders and managers
About You:
Do you enjoy working in a highly team-oriented and fast-paced role? We’re looking for someone with strong leadership and communication skills who thrives in a dynamic, collaborative environment. The ideal candidate is a quality professional with experience in biopharmaceutical development of cell and gene therapy products. Other role requirements include:
- Advanced Degree in Science, Engineering, or related discipline required with a minimum of 15 years of experience in the biopharmaceutical industry. Experience in cell and gene therapy is a plus
- A minimum of 5 years leading pharmaceutical Quality Assurance, Quality Systems and/or Quality Operations; ideally including all phases from clinical through commercial drug product
- Strong knowledge of global regulations including EU and USA
- Strong understanding of the science/engineering of manufacturing platforms and the rationale and purpose of analytical methods
- Exceptional communication skills including writing, presentation, influencing, and negotiation skills
- Ability to lead and provide guidance to multiple projects simultaneously
- Demonstrated ability to build, develop, and lead a team of quality professionals in support of corporate goals
- Experience managing/working with third parties and effectively using strong interpersonal skills/diplomacy, and negotiation skills to influence and accomplish work
- In-depth understanding and application of industry standards and cGMP/regulations and guidelines is required
Meet your Future Team:
In this role, you will report to the SVP of Technical Operations and Quality and will be a member of the Tech Ops & Quality Leadership Team. We are a diverse group of leaders with a range of backgrounds and collective experiences that make us stronger as a team and enable the ability to learn from each other. There is no road map for what we are doing as leaders in the systemic delivery of in vivo CRISPR-Cas9 therapies while offering a full spectrum approach to create CRISPR-Cas9 therapy via our ex vivo pipeline. We thrive on charting new territory, exploring new ways to drive our programs and the business forward, while promoting and cultivating the culture of ONE that has made, and continues to make, Intellia such an incredible place to work. We look forward to fostering your skills, strengthening our leadership through learning from your experiences, and working together as ONE to transform the lives of people with severe diseases by developing curative genome editing treatments.
#LI-KD1
Covid-19 Vaccination Policy: Effective Monday, January 3, 2022, all Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. 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.
Company
Many of us pursuing work in the biotechnology industry are inspired by a loved one who is living with a disease or the loss of someone in our community. Rare genetic and oncological and immunological diseases not only affect the people living with often debilitating and life-threatening symptoms, but these disorders also significantly impact their families, friends and caregivers.
Our researchers work tirelessly to harness the genome editing technology CRISPR/Cas9 for human therapeutic use. Jennifer Doudna, an Intellia co-founder, and Emmanuelle Charpentier were awarded the 2020 Nobel Prize in Chemistry for their pioneering work in CRISPR. We at Intellia are humbled to have a hand in making what we believe to be medical history. As a leader in this space, we take this responsibility to patients seriously.
We are employing a modular genome editing platform to create diverse in vivo and ex vivo pipelines, spanning a range of therapeutic indications. Guided by this full-spectrum approach, we are committed to making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to creating novel engineered cell therapies for various cancers and autoimmune diseases.
Change life stories with genome editing therapies!
Stock Symbol: NTLA
- Website
- http://intelliatx.com/
- Phone
- (857) 285-6200
- Location
-
40 Erie Street
Cambridge
Massachusetts
02139
United States
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