Senior Director, Clinical Quality Assurance (CQA)

The role

The Senior Director of Clinical Quality Assurance will provide strategic and operational Quality Assurance leadership and oversight for multiple global 4DMT-sponsored clinical trials. This role ensures trials comply with international regulatory requirements for Good Clinical Practice.

What you will do

• Provide strategic Quality leadership and oversight for multiple 4DMT Clinical Studies
• Serve as a senior Quality partner to clinical study teams and leadership
• Lead the development, implementation, and governance of Clinical Study Quality Plans
• Manage, mentor, and develop Clinical QA staff and consultants
• Define, plan, perform, and/or oversee risk-based GCP Compliance audits
• Ensure audit findings, quality risks, and CAPA commitments are communicated to senior stakeholders
• Provide senior Quality review and strategic input on Clinical documents
• Lead and/or provide oversight for investigation and management of significant Clinical Study Quality Events
• Oversee and provide strategic direction for development of GCP compliance training materials
• Define and lead GCP inspection readiness strategy, plans, and cross-functional readiness activities

Required qualifications

• Bachelor's degree in a life science, nursing, pharmacy, or related field
• 12+ years of experience or advanced degree with 10+ years of experience within a regulated environment such as Regulatory, Quality, Pharmacovigilance or Clinical Development / Operations within the Bi
• Minimum of 7 years of significant experience in clinical quality assurance, including experience leading, performing, and/or providing senior oversight of GCP audits and global clinical trials
• Experience hosting, leading, and supporting health authority inspections
• Extensive practical experience and understanding of clinical quality assurance applied throughout the clinical development life-cycle
• Demonstrated ability to influence senior cross-functional stakeholders, lead complex clinical quality initiatives, and provide mentorship or functional leadership within Clinical QA
• Expert understanding of GCP requirements for investigational products
• Executive-level communication skills, both oral and written
• Strong leadership, influencing, and interpersonal skills
• Demonstrated ability to operate independently in a fast-paced small company environment
• Travel: 5%

Nice to have

• Advanced degree (MS, PharmD, PhD)
• Experience in Ophthalmology is highly desired

About the company

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics. The company's lead product candidate 4D-150 is designed to provide multi-year sustained delivery of anti-VEGF biologics.