Associate Director Quality Assurance

Are you ready to join Connecticut Innovation’s vibrant community of innovators? Connecticut Innovations (“CI”) is Connecticut’s strategic venture capital arm, and we are passionate about serving our portfolio of 220+ companies across various industries, with strengths in life sciences, technology, and climate tech. Come join First-in-Class Dermatology Drugs | Veradermics! Founded in 2019, Veradermics, Incorporated (NYSE: MANE) is a well-funded, publicly listed company that offers the opportunity to work in a performance-driven, highly dynamic environment. At Veradermics, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Veradermics is a dermatologist-founded, late clinical-stage biopharmaceutical company focused on developing innovative therapeutics for common aesthetic and dermatological conditions. Veradermics lead product candidate, VDPHL01, is an oral, non-hormonal treatment for men and women with pattern hair loss (PHL). We are currently conducting three Phase 3 clinical trials as we work to deliver potentially transformative solutions and aspire to redefine the standard of care in dermatology. Learn more here. At Veradermics, we combine scientific rigor with a vision for impactful innovation to make a lasting difference in the lives of patients. Why Work at Veradermics You Can Be Part of a Meaningful Mission: Veradermics aims to become a leader in medical dermatology by bringing pharmaceutical innovation to the treatment of common skin conditions to improve the lives of patients. Veradermics is Growing: Veradermics is a dynamic and growing company; we are advancing our VDPHL01 Phase 3 clinical trials and preparing for commercialization. PHL affects approximately 80 million people in the U.S. alone. The Veradermics Culture: We are an innovative, collaborative, hard-working and performance-driven company that values the contributions of our employees and keeps our focus on patients Position Overview The Associate Director, Quality Assurance role reports to the VP of Quality. This role will oversee QMS document control as the Administrator of the eQMS and LMS system to ensure documentation complies with internal polices and external regulations (FDA, ICH). This role requires a strong ability to collaborate with various teams, document procedures, and stay current with changing industry standards. Responsibilities Quality Systems & Regulatory Compliance Lead the development, implementation, and maintenance of GMP and GCP quality systems, ensuring alignment with FDA, EMA, ICH, and other global regulatory requirements. Serve as a primary quality representative for internal teams and external partners, providing expert guidance on compliance expectations. Maintain a state of inspection readiness and act as a key participant during regulatory inspections (FDA, EMA, MHRA) and sponsor audits. Anticipate and address infrastructure gaps that could impede inspection readiness or regulatory compliance. Develop and maintain quality policies, procedures, and work instructions aligned with current regulatory expectations. Create, revise, and maintain controlled documentation within electronic quality systems. Consult with management to develop and implement solutions for achieving quality-related objectives. Clinical Trial Quality Oversight Provide quality oversight for clinical trials, including review of protocols, monitoring plans, investigator site files (ISFs), and clinical documentation. Lead GCP audits of CROs, investigator sites, and vendors; ensure findings are addressed through effective CAPAs. Partner with Clinical Operations, Pharmacovigilance, and Regulatory Affairs to ensure trial conduct aligns with ICH E6(R2), E8, and applicable regional regulations. Perform quality control review of Trial Master File (TMF) assembly and transfers to ensure accuracy and compliance with regulatory and sponsor requirements. Quality Documentation & Systems Management Ensure timely and accurate documentation within electronic quality systems (e.g., deviations, CAPAs, change controls, audit reports). Support Change Controls and Corrective and Preventive Actions (CAPA). Support Corrective and Preventive Actions (CAPA) process, including investigation, root cause analysis, and verification of effectiveness. Maintain Quality initiative key performance indicators (KPIs) and provide regular reporting to senior leadership. Prepare quality summaries, risk assessments, and reports for internal leadership and regulatory submissions. Cross-Functional Partnership & Leadership Serve as a trusted advisor to clinical, regulatory, and operations teams on quality and compliance matters. Partner with Quality, Regulatory Affairs, and Clinical teams to ensure alignment on regulatory strategy and quality standards. Communicate quality expectations clearly to internal teams and external partners (CROs, sites, vendors). Lead or participate in quality-related meetings, strategy sessions, and decision-making forums. Support continuous quality improvement initiatives and drive quality culture across the organization. Audit Coordination & Inspection Readiness Lead preparation for regulatory inspections and sponsor audits, including document preparation, team coordination, and mock inspections. Conduct audits of external partners (CROs, investigator sites, vendors) and ensure CAPA closure and verification. Maintain documentation and evidence of inspection readiness (training records, SOPs, quality files, deviation trends). Coordinate with internal teams to address inspection findings and implement systemic improvements. Perform other related duties as assigned or necessary; remain flexible and adaptable in work schedules and assignments as defined by departmental and organizational needs. Candidate Profile | Who You Are Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or related field required; advanced degree preferred. 8+ years of pharmaceutical, biotech, or medical device experience , with at least 5+ years in a quality assurance, quality operations, or regulatory compliance role. Deep knowledge of GMP (FDA 21 CFR Parts 210/211) and GCP (ICH E6(R2)) principles and requirements. Experience with clinical trial quality oversight , including review of ISFs, TMFs, protocols, and monitoring plans. Demonstrated experience conducting audits (internal or external) and managing CAPAs in a regulated environment. Knowledge of ICH guidelines (E6, E8, E9, Q10) and regional regulatory requirements (FDA, EMA, MHRA). Experience with quality systems and electronic documentation (deviations, change controls, CAPAs, audit trails). Strong understanding of quality risk management and ability to assess and mitigate quality risks. Experience supporting regulatory inspections (FDA, EMA, MHRA, or sponsor audits) preferred. Experience in clinical operations or clinical trial oversight preferred. Location and Travel Requires 1–2 days per week in the office, with additional presence during board meetings, All Hands, or key events Salary and Benefits Veradermics provides a comprehensive compensation package that includes a base salary, annual performance bonus eligibility, and access to the employee stock option plan. Robust benefits package, including health coverage, retirement benefit matching, dependent care FSA, and unlimited paid time off. Equal Opportunity Employer Veradermics is an equal opportunity employer. All employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, or age. #J-18808-Ljbffr