Quality Assurance and Regulatory Affairs Lead

2 weeks ago

Cambridge, Massachusetts, United States Kytopen Full time
Position Overview

Kytopen is at the forefront of enhancing cell engineering for advanced cell therapies, aiming to broaden access to innovative living medicines. Our unique continuous Flowfect non-viral transfection platform is designed to deliver rapid, scalable, and gentle processes that produce billions of high-quality engineered cells in mere minutes while preserving cell integrity and functionality. We are in search of dedicated and innovative professionals to help us realize our mission of delivering this groundbreaking technology.

Role Summary: We are seeking a Quality Assurance and Regulatory Affairs Lead to become part of our team on a contractual basis, with the possibility of transitioning to a permanent role. The ideal candidate will possess extensive expertise in the documentation essential for the development and commercialization of tools used in cell and gene therapy manufacturing, and will also be adept at serving as the regulatory liaison with clients and strategic partners.

Key Responsibilities:

  • Deliver quality and regulatory support for vendor and supplier-related tasks, including the establishment of quality agreements, preparation of audit reports, and management of supplier corrective and preventive actions (CAPA).
  • Oversee internal records management through our quality management system.
  • Interpret and implement relevant regulatory guidelines and directives (e.g., 21CFR, USP, EP) to ensure product quality, while staying informed of updates and advising stakeholders accordingly.
  • Collaborate with the product development team to supervise the validation and verification processes of our devices.
  • Lead regulatory affairs initiatives, encompassing the preparation of regulatory submissions and engagement with regulatory bodies.
  • Coordinate with cross-functional teams to address quality and regulatory challenges.

Qualifications:

  • A minimum of 8 years of experience in quality assurance and regulatory affairs within the life sciences instrumentation sector.
  • Comprehensive understanding of current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOP), FDA regulations, Premarket Approvals (PMAs), and other pertinent regulations.
  • Demonstrated experience with biomanufacturing tools, particularly in cell and gene therapy production.
  • Strong problem-solving and decision-making skills.
  • Capability to manage multiple tasks and projects concurrently.
  • Exceptional written and verbal communication abilities.
  • Proficiency in utilizing various software and databases for quality assurance and regulatory affairs.

What We Offer:

As a values-driven and creative organization, we recognize that our success is attributed to the talented individuals on our team. We provide competitive compensation, including a 401k match and equity options, a comprehensive health benefits package, and a supportive work environment that features hybrid work schedules, flexible vacation policies, paid family leave, and support for ongoing education.

Kytopen's Core Values:

Impact: Our work has the potential to deliver significant benefits to patients. We strive to make a measurable difference for each other, our external partners, and users of our technology.

Resilience: We adapt to change and emerge stronger. We tackle new challenges with determination and flexibility, discovering innovative solutions.

Integrity: We are committed to excellence from the outset. We uphold the quality of our data and foster trustworthy, productive partnerships. We embrace feedback with a commitment to transparency and continuous improvement.

Inclusivity: In the Kytopen community, every voice is valued. We actively cultivate a welcoming, collaborative environment where team members are prioritized as individuals, fostering relationships that drive innovation and problem-solving. We maintain a growth mindset and consistently challenge our biases.

Passion: We are fully committed, understanding that our contributions matter.

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