We are seeking a motivated and qualified individual to join our team as an Associate Director, Clinical Quality Assurance. This role provides strategic and operational leadership for the Clinical QA function, ensuring the highest standards of Good Clinical Practice (GCP) compliance across all clinical programs. This role is responsible for building and maintaining a robust, risk-based quality framework that supports all stages of clinical development, regulatory submissions, and sustained inspection readiness. The role will serve as a key partner across functions, driving a culture of quality, compliance, and continuous improvement.
Essential Responsibilities:- Develop and execute the Clinical QA strategy aligned with organizational and development goals
- Develop, implement, maintain and continuously improve phase-appropriate, risk-based clinical. quality systems, processes, SOPs and policies to support early and late phase clinical trials and regulatory submissions.
- Implement proactive, risk-based approaches to identify, assess, and mitigate quality and compliance risks.
- Provide ongoing GCP quality oversight and support to ensure adherence to global GCP, quality and compliance requirements across all clinical programs.
- Partner closely with Clinical Operations, Clinical Development, Regulatory Affairs, Data Management, Biometrics, CMC, Clinical Supply Chain and study teams to proactively identify and mitigate compliance risks and ensure operational compliance.
- Provide Clinical QA oversight for CROs, laboratories, and other clinical vendors. Ensure appropriate qualification, monitoring, and oversight are in place.
- Review and contribute to key clinical and regulatory documents including INDs, protocols, IBs, NDAs, and other trial and submission-related materials, as applicable.
- Lead the planning and execution of a comprehensive, risk-based GCP audit program (investigator sites, CROs, vendors, and processes).
- Oversee the management of audit findings and drive effective CAPA implementation.
- Oversee and support investigations of deviations, noncompliance and quality events, ensuring thorough root cause analysis, CAPA implementation and proper documentation.
- Lead organizational inspection readiness activities for late phase programs and global regulatory authority inspections (e.g., FDA, EMA).
- Ensure systems are inspection-ready and aligned with evolving regulatory expectations.
- Serve as Clinical QA lead for regulatory inspections, including preparation, hosting, and post-inspection response management.
- Support NDA/BLA/MAA submission activities from a quality perspective.
- Influence and embed quality principles across the clinical development lifecycle.
- Develop and deliver annual GCP training programs and quality-related trainings.
- Communicate regulatory changes, best practices and compliance expectations to internal stakeholders.
- Collaborate closely with the broader Quality team to execute Quality objectives and ensure alignment across GxP areas.
- Foster a culture of inspection readiness and continuous improvement across the organization
Essential Physical Characteristics:Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis.
On-Site Protocol:Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
Travel RequirementsApproximately 10-20% travel may be required.
Qualifications:
- Bachelor's degree in life sciences, pharmacy, or related field; advanced degree preferred
- 10+ years of progressive GCP Quality Assurance experience in the biotechnology or pharmaceutical industry
- Direct experience supporting late-stage clinical trials (Phase 2/3) and NDA/MAA submission preparation, with proven inspection readiness experience
- Expert knowledge of global GCP regulations and guidance, including but not limited to:
- 21 CFR Parts 11, 50, 54, 56, 312
- EU Clinical Trial Regulation (EU-CTR)
- ICH E6(R2/R3), ICH E8
- General Data Protection Regulation (GDPR)
- Good Clinical Laboratory Practice (GCLP)
- Extensive experience leading GCP audits (internal, investigator sites, CROs, and vendors) and managing regulatory inspections
- Demonstrated ability to operate both strategically and hands-on in a small, fast-paced biotech environment
- Excellent communication, collaboration, and influencing skills across cross-functional teams
Required Key Attributes:- Strategic mindset with strong execution capability
- Deep expertise in GCP and clinical development processes
- High integrity and commitment to quality and compliance
- Strong leadership and stakeholder influence
- Solutions-oriented with a proactive, risk-based approach
Compensation:- This is a full-time position, Monday-Friday, occasional overtime.
- Pay is commensurate with experience.
- Equity-based compensation
- Performance-based bonuses
- 401(k) with Company Match
- Medical, Dental, Vision
- Flexible Spending Account
- Life Insurance
- Employee Assistance Program
- Employee Discounts
- Gym Membership
- Paid Vacation
- Paid Holidays
- Paid Sick, Jury Duty, Bereavement
Work Authorization:- United States (Required)
- Background Check
- As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check.
