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Senior Manager, Supplier Quality Assurance

Location
Cambridge, Massachusetts
Job Type
Permanent
Posted
13 Jun 2022

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:

As Intellia's Senior Manager of Supplier Quality Assurance, you will be instrumental in the management and evolution of the Supplier Quality Program and systems to meet the challenges of global supply of late-stage clinical drug product and commercial drug product. The Senior Manager of Supplier Quality will be responsible for the GxP supplier management program which oversees contract manufacturing organizations, testing laboratories and material/service providers. This role will act as interdepartmental liaison to various groups including Manufacturing, Supply Chain, Quality Control, and Development.

In this role, you will:

  • Manage Intellia's Supplier Quality program, including the approved supplier list, external audits, Quality Agreements, supplier performance monitoring, supplier development and lifecycle management

  • Ensure that Intellia's supply chain meets phase-appropriate global regulatory and industry standards (/cGXP) to support early and late-stage clinical drug products

  • Manage the supplier audit plan, including Qualified Person (QP) audits to establish/maintain QP Declaration of supply chain GMP compliance in Europe

  • Establish and maintain Qualified Person (QP) agreements throughout the supply chain, and manage QP relationships

  • Collaborate with external and internal stakeholders to ensure supplier partnerships and contractual commitments are well understood and executed appropriately

  • Develop effective training and communication tools to ensure internal stakeholders and suppliers comply with Intellia's Supplier Quality Program requirements

  • Manage the Supplier Change Notification and Supplier Corrective Action Reporting processes

  • Develop and implement supplier performance scorecards, and present supplier quality metrics for routine updates to Management teams

  • Manage and mentor a highly-skilled Supplier Quality team and consultants.

  • Support the Clinical Operations Vendor management program

  • Lead supplier audits, ensure audit response and follow-up

  • Assist in the development and implementation of GxP quality standards, policies, and procedures; support internal audits as required

  • Implement electronic supplier quality management system workflows

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 15 years of experience in a GxP-regulated biopharmaceutical environment (cell and gene therapy) and at least 5 years of experience in Supplier Quality program management. Other role requirements include:

  • Bachelor's or Master's degree in Science, Engineering, or related discipline

  • In-depth understanding and application of regional regulatory requirements/guidelines specific to GxP (e.g. FDA, EU)

  • Comprehensive knowledge and ability to audit to GMP and ICH regulations, ISO standards

  • Experience as Lead Auditor and managing the audit plan

  • Experience working with Qualified Personnel (QP) and QP Agreements

  • Experience negotiating Quality Agreements, SCARs, Supplier development/improvement plan

  • Strong understanding and background in quality principles and tools such as risk management, process controls, key performance indicators, statistical analysis etc.

  • Exceptional communication skills including writing, presentation, influencing, and conflict management

Meet your future team:

You will report to the Head of Supplier Quality and be a member of Technical Operations and Quality team. Our Supplier Quality team is growing to meet the challenges of maintaining supply chain compliance for approved clinical products in all phases, including early to late phase clinical studies, improving supply chain compliance, and streamlining the Supplier Quality program in readiness for commercial drug product supply. The Supplier Quality team is working remotely until COVID restrictions are lifted, and we will be adopting a flexible hybrid model after. While we build our team, we will be supported by a team of qualified consultants, including Lead auditors with GXP experience.

As a company, 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 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. It's no wonder Intellia is placed on BioSpace's Best Places to Work 2022, Top 30 Small Employers list.

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.

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.

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Details

  • Job Reference: 623855061-2
  • Date Posted: 13 June 2022
  • Recruiter: Intellia Therapeutics
  • Location: Cambridge, Massachusetts
  • Salary: On Application
  • Sector: Healthcare & Medical
  • Job Type: Permanent