Manager/ Sr. Manager Of Quality Assurance Gcp/Gclp/Glp

Manager/ Sr. Manager of Quality Assurance GCP/GCLP/GLP

Dragonfly Therapeutics is seeking a highly motivated and talented Manager/ Sr. Manager to lead the GLP/GCLP/GCP Quality Assurance function. Working closely with the Clinical Operations, Translational Medicine, and Toxicology Teams at Dragonfly, this role will have primary responsibilities for the QA oversight of GLP/GCLP/GCP activities internally, and at its CROs, Clinical Sites, and third-party laboratories and vendors. Reporting to the Head of Quality Assurance, this role will develop and implement a phase-appropriate quality system that supports quality and compliance of clinical and nonclinical activities at Dragonfly. Overall, the successful candidate will be a key member of Dragonfly’s talented team and play an important role in bringing novel therapies to patients.

Responsibilities:

• Oversee QA review and approval of GLP and GCLP study protocols and reports, clinical study reports, ICFs, external publications, and regulatory submissions (i.e., IND/IMPD)
• Develop and implement an early-stage clinical site quality audit program in collaboration with clinical study teams
• Collaborate and provide QA expertise in processes such as investigations, corrective and preventive action (CAPA) plans, trial protocol deviations, complaints, DSURs, risk management, risk assessments, recalls, safety events/reporting, relevant regulatory submission sections, and trial documentation review
• Lead the nonclinical and clinical vendor, and internal quality audit programs
• Develop training materials and conduct training
• Design and execute on the audit plans/schedules in collaboration with nonclinical and clinical development teams, including establishment of appropriate quality compliance criteria, to assure compliance with regulations, guidelines, and standards
• Ensure the nonclinical and clinical sites are audit ready and compliant at all times
• Lead the nonclinical/clinical QA function to develop and implement a quality system in accordance with ICH Guideline E6 (R2) Good Clinical Practice (GCPs), 21 CFR part 58 Good Laboratory Practices (GLP), and other global regulatory authority requirements, and industry practices
• Develop and implement QA GLP/GCLP/GCP systems, risk management processes, and SOPs for internal and external oversight operations
• Generate clinical and nonclinical QA metrics and present at senior leadership meetings

Qualifications:

• At least 8+ years’ experience in pharmaceutical / biotech / clinical research industry with significant experience in GLP/GCLP/GCP environment (title commensurate with experience)
• Must have proficient computer skills and be experienced using MS office software (Word, Excel, PowerPoint, Project)
• Prior experience with nonclinical studies and CRO oversight
• Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately
• Previous direct QA experience in GLP/GCLP/GCP in pharma required
• Ability to work in a fast-paced environment, meet deadlines, and balance multiple priorities
• BS/MS in biology, chemistry, life sciences or related field
• Ability and willingness for approximately 20% travel – domestic and international, consistent with project needs
• Independently motivated, detail-oriented, and “can-do” attitude

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 cancer treatment by inventing natural killer cell-based therapies for vastly improved patient outcomes. We believe in a small team with a big impact.

Dragonfly Therapeutics, Inc. | 35 Gatehouse Drive, Waltham, MA 02451 | dragonflytx.com