Back to jobs

Head of Quality

Waltham, Massachusetts, United States

Head of Quality

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.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter*

Accepted file types: pdf, doc, docx, txt, rtf

Education

Select...
Select...
Select...
Select...
Select...
Select...
Select...

When you apply to a job on this site, the personal data contained in your application will be collected by Dragonfly Therapeutics (“Controller”), which is headquartered at 180 3rd Avenue, Sixth Floor, Waltham MA, 02451 and can be contacted by emailing hr@dragonflytx.com. Controller’s data protection officer is MWB Consulting SARL, who can be contacted at dpo@mwbconsulting.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. Because the European Union Commission has determined that United States data privacy laws do not ensure an adequate level of protection for personal data collected from EU data subjects, the transfer will be subject to appropriate additional safeguards under standard contractual clauses. You can obtain a copy of the standard contractual clauses by contacting us at hr@dragonflytx.com.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with an EU supervisory authority.

Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Dragonfly Therapeutics’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.