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Senior Director Quality GMP Operations

Employer
Intellia Therapeutics
Location
Cambridge, MA
Start date
Jun 13, 2024

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Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work

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 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.

How you will Achieve More with Intellia:

Reporting directly to the VP/Head of Quality, the Senior Director Quality GMP Operations will play a key role in managing QA and QC oversight activities for Intellia. The Senior Director Quality Operations will be responsible for Quality related activities for clinical phase 1/2 material and commercial products including transition from development (Phase III) into commercial. This role will partner closely with Quality and business stakeholders to ensure identification and mitigation of risks, alignment with regulatory and commercial strategy and continuing support of Intellia’s clinical development pipeline. The Sr. Director will also participate in/lead Quality governance committees and is accountable for ensuring timely program stage review. This role is also responsible for critical supplier relationships and active Quality engagement with these suppliers.

In this role you will have the opportunity to:

  • Support preparation of CMC investigational and commercial regulatory submissions by critically reviewing and approving relevant documents per program timeline and associated HA information requests on the filing.

  • Represent Quality in program discussions and serve as a trusted advisor and partner to establish the CMC quality strategy and roadmap for innovative therapeutic programs.

  • Lead appropriate governance meeting topics for Quality members to critically review proposed complex changes (e.g., multi-product or multi-site), promoting a risk-based approach to change control. Ensure/facilitate effective bi-directional communication between the Quality groups and cross-functional teams and ensuring standardized processes (e.g., new product introduction, risk assessments, technology transfers, etc.) are used across sites.

  • Lead the quality assessment for product lifecycle changes, efficiency projects, and continuous improvement projects.

  • Support partner, supplier and internal audits as necessary.

  • Create and maintain Standard Operating Procedures relating to areas of responsibility.

  • Support statistical trending of manufacturing and analytical data.

  • Lead overall management of Quality Assurance programs to support the QC function and to ensure they are meeting expectations, which include oversight of raw material qualification, lab investigations, stability program, etc.

  • Review and approve deviations, CAPAs, SOPs and Change Control related to QC operations

  • Create and foster a culture of collaboration, development, and engagement for advancing quality outcomes and operational excellence within quality and with external stakeholders.

  • Lead and mentor other team members, support development of organizational capabilities and talent building

About You:

  • BS degree in Chemistry, Engineering, Life Science or related discipline and a minimum of 15 years of relevant Quality Assurance experience; advanced degree and a minimum of 10 years relevant experience required

  • Extensive knowledge of global cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance. ATMP experience a plus.

  • Ability to drive functional, technical, and operational excellence. Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.

  • Ability to solve complex problems and take proactive action

  • Ability to motivate a team, recognize and develop good talent and bring out the best out of each individual.

  • Must be able to guide statistical analysis and capable of analyzing data to solve problems

  • Experience developing and overseeing laboratory SOPs and revisions according to FDA/ICH guidelines

  • Solid knowledge of all QC laboratory equipment and manufacturing equipment

  • Direct experience with investigations and root cause analysis in pharmaceutical or medical device products.

  • Experience with internal and external audits.

  • Experience reviewing manufacturing and QC validation documents.

  • Demonstrate ability to manage projects and variable workloads.

  • Excellent communication and coaching skills (verbal and written).Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.

Meet your future team:

This role reports directly to the VP Head of Quality at Intellia. This is a hands-on role where you will be leading a dynamic team who are passionate about quality and are patient centric. Intellia’s quality group has grown quickly over the past two years to support the multiple cell and gene programs in our advancing pipeline. You will be in a fast-paced dynamic remote friendly work environment with a team that knows how to support progress to late-stage clinical development of multiple ATMP modalities. At Intellia we believe genome editing has incredible potential to treat and cure life-threatening and fatal diseases, and in this role, your contributions will be essential towards that effort.

#LI-KO2

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.

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

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Company info
Website
Phone
(857) 285-6200
Location
40 Erie Street
Cambridge
Massachusetts
02139
US

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