Associate Director, Quality Assurance

Company Overview

Founded in 2019, Veradermics, Incorporated (NYSE: MANE) is a publicly traded, well-funded biopharmaceutical company specializing in innovative treatments for dermatological and aesthetic conditions. The company focuses on developing transformational therapeutics, including their lead candidate VDPHL01, a novel oral, non-hormonal treatment for pattern hair loss currently in three Phase 3 clinical trials. Veradermics fosters a performance-driven, collaborative environment that promotes professional growth and values employee contributions aimed at improving patients' lives.

Role Summary

The Associate Director of Quality Assurance, reporting to the VP of Quality, will manage Quality Management System (QMS) document control as the primary administrator of electronic QMS and Learning Management Systems (LMS). The role ensures compliance with internal policies and external regulations including FDA and ICH standards and necessitates close collaboration with multiple teams to maintain updated procedures reflecting evolving industry standards.

Key Responsibilities

• Direct development, implementation, and upkeep of Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) quality systems in alignment with FDA, EMA, ICH, and other global regulatory requirements.
• Act as the principal quality liaison for internal departments and external partners, providing expert advice on compliance obligations.
• Maintain continuous inspection readiness and actively participate in regulatory inspections and audits (FDA, EMA, MHRA, sponsors).
• Identify and resolve infrastructure deficiencies that might impede regulatory compliance or readiness.
• Develop and update quality policies, procedures, and work instructions to reflect current regulatory standards and ensure compliance.
• Manage controlled documents within electronic quality systems effectively, including revisions and new document creation.
• Guide management on achieving quality objectives through development and implementation of effective solutions.
• Oversee clinical trial quality by reviewing protocols, monitoring plans, Investigator Site Files (ISFs), and clinical documentation.
• Lead Good Clinical Practice audits of Contract Research Organizations (CROs), investigator sites, and vendors with thorough follow-up on corrective and preventive actions (CAPAs).
• Collaborate closely with Clinical Operations, Pharmacovigilance, and Regulatory Affairs to guarantee that trial management complies with ICH E6(R2), E8, and regional regulatory norms.
• Conduct quality control reviews of Trial Master File (TMF) assembly and transfers ensuring regulatory adherence and sponsor requirements.
• Ensure accurate and timely documentation in electronic quality systems covering deviations, CAPAs, change controls, and audit reports.
• Support CAPA processes including investigations, root cause analysis, and effectiveness verification.
• Maintain and report Quality initiative key performance indicators (KPIs) regularly to senior leadership.
• Prepare comprehensive quality summaries, risk evaluations, and reports for leadership and regulatory submissions.
• Serve as a reliable quality advisor fostering alignment between clinical, regulatory, and operational teams.
• Lead or contribute to quality-related meetings, strategy planning sessions, and decision-making forums.
• Champion continuous quality improvement and drive a culture of quality across the organization.
• Coordinate preparations for regulatory inspections and sponsor audits, including document organization, team readiness, and mock inspections.
• Conduct audits of external partners and ensure timely resolution and verification of corrective actions.
• Maintain thorough documentation evidencing inspection readiness, including training records, SOPs, and deviation tracking.
• Collaborate internally to respond effectively to inspection outcomes and implement necessary systemic enhancements.
• Fulfill additional responsibilities as assigned to adapt to departmental and organizational priorities.

Candidate Profile

• A Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or related fields is mandatory; an advanced degree is advantageous.
• Possesses over 8 years of experience in pharmaceutical, biotechnology, or medical device sectors, including at least 5 years in quality assurance, operations, or regulatory compliance.
• In-depth understanding of GMP (FDA 21 CFR Parts 210/211) and GCP (ICH E6(R2)) regulations.
• Experienced in clinical trial quality management, including review of ISFs, TMFs, protocols, and monitoring frameworks.
• Proven expertise in conducting audits and managing CAPA processes within regulated environments.
• Familiar with ICH guidelines (E6, E8, E9, Q10) and regional regulatory bodies (FDA, EMA, MHRA).
• Proficient with quality systems and electronic documentation tools for tracking deviations, CAPAs, change controls, and audit trails.
• Strong skills in quality risk management, with the ability to identify and mitigate risks effectively.
• Preferred experience supporting regulatory inspections such as FDA, EMA, MHRA, or sponsor audits.
• Clinical operations or clinical trial oversight experience is desirable.

Company Culture

Veradermics is a small, close-knit team operating with urgency, a positive outlook, and a profound sense of ownership. They set high standards and value individuals motivated to contribute significantly within a rapidly evolving organization. The culture emphasizes organization, collaboration, honest communication, and collective success through overcoming complex challenges.

Work Location & Schedule

• This is a hybrid position based in New Haven, Connecticut.
• Requires 1–2 days per week in office, with additional presence expected for key meetings and events such as board meetings and all-hands gatherings.

Compensation & Benefits

• Competitive base salary with eligibility for annual performance bonuses.
• Participation in an employee stock option program.
• Comprehensive benefits including health insurance, retirement plan matching, dependent care FSA, and unlimited paid time off.

Equal Opportunity Statement

Veradermics provides equal employment opportunities based on qualifications and business needs without discrimination on race, color, religion, gender identity or expression, sexual orientation, national origin, disability, or age.