Head of Quality Waltham, Massachusetts, United States

Dragonfly Therapeutics is seeking a knowledgeable, experienced, and motivated Quality Assurance professional to join our team and lead the Clinical Quality Assurance function to ensure the highest standards of quality and compliance in clinical research and related activities. Level commensurate with experience. The role is responsible for developing and implementing quality assurance strategies, including therapeutic area, process, and vendor audit and inspection strategies to ensure compliance with regulatory requirements and company standards. This individual will be instrumental in advancing our Global Quality vision and strategy in support of our clinical research endeavors to innovate and deliver therapeutic solutions for patients.

Responsibilities (including but not limited to):

• Lead the Clinical Quality Assurance function, providing strategic direction, oversight and coaching to the CQA team, fostering a culture of quality and continuous improvement for the organization.
• Manage Dragonfly's Quality department with responsibilities for all GXP oversight, including Quality Control.
• Develop, implement, and maintain quality assurance policies, procedures, and systems to ensure compliance with GCP, ICH guidelines, and regulatory requirements.
• Engage with executive management and cross functional business partners to identify areas of greatest compliance risk and obtain information and feedback relevant to process improvement and issue resolution.
• Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to business partners and senior management.
• Lead vendor quality oversight activities and manage external quality (e.g. quality agreements with CROs, set vendor quality councils, etc.).
• Provide leadership and oversight for GCP Inspections ensuring effective readiness, preparation, management, and response development and action closure.
• Ensure timely identification, investigation, and resolution of quality issues and non-compliance.
• Develop and deliver training programs to enhance quality awareness and compliance across the organization.

Requirements:

• Expertise in regulatory submission structure and content (e.g. IND, CTA, MAA, NDA, BLA).
• Extensive knowledge of non-clinical and clinical development, regulatory guidelines of FDA, ICH, EMA, EU NCAs, MHRA and other international regulatory agencies.
• Demonstrated track records of successful regulatory meetings, IND or BLA submissions and approvals.
• Extensive understanding of requirements for regulatory submissions, including IND or BLA.
• Excellent written and oral communication skills, with expertise to independently present complex information to senior management, consultants, regulatory authorities and the medical community.
• Demonstrated ability to blend analytical critical thinking, problem-solving, organizational and negotiation / decision-making skills to enable scientific data-driven, regulatory compliant narratives of regulatory documents.
• Expertise to write scientific and technical documents.
• Demonstrated ability to work in an innovative and fast-paced environment.
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.

About Dragonfly

Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients. In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas.

Our mission is to revolutionize disease treatment by inventing natural killer cell-based therapies for vastly improved patient outcomes. We believe in a small team with a big impact.