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

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

Dragonfly Therapeutics is seeking a highly motivated and talented individual 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:

• 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
• 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)
• 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
• Develop and implement an early-stage clinical site quality audit program in collaboration with clinical study teams
• Lead the nonclinical and clinical vendor, and internal quality audit programs
• 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
• Develop training materials and conduct training
• Generate clinical and nonclinical QA metrics and present at senior leadership meetings

Qualifications:

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