Associate Director, Clinical Quality Assurance

Accountabilities

Lead the development, implementation, and maintenance of GCP quality assurance programs, policies, procedures, and processes supporting clinical development activities.
Serve as the primary GCP quality assurance expert and point of contact, providing guidance on regulatory expectations, industry standards, and applicable ICH guidelines.
Ensure clinical programs comply with global health authority regulations, including relevant FDA, EMA, and MHRA requirements, as well as internal standard operating procedures.
Provide quality oversight and review of clinical trial documentation, including protocols, informed consent forms (ICFs), clinical study reports (CSRs), and other essential trial records.
Monitor evolving GCP regulations and industry guidance, assess their impact on clinical operations, and communicate relevant changes to stakeholders.
Develop and execute global, risk-based audit strategies and annual audit plans, covering investigator sites, contract research organizations (CROs), suppliers, systems, processes, and clinical documentation.
Conduct and oversee audits, prepare comprehensive audit reports, assess corrective and preventive action (CAPA) plans, and monitor follow-up activities to ensure effective resolution of findings.
Lead inspection readiness initiatives and support regulatory inspections conducted by health authorities, ensuring appropriate documentation, preparation, and response management.
Collaborate with cross-functional teams and represent Clinical Quality Assurance on study teams, contributing to protocol development, clinical risk management, and quality-by-design initiatives.
Identify potential compliance risks, investigate quality issues, conduct root cause analyses, and implement effective mitigation strategies and CAPA plans.
Develop and maintain GCP-related standard operating procedures, templates, forms, training materials, and quality performance metrics.
Track and present key performance indicators (KPIs), audit progress, compliance trends, and quality-related updates to leadership.
Drive continuous improvement initiatives across quality assurance and the wider organization, strengthening operational efficiency and a proactive quality culture.
Provide technical guidance, coaching, and mentorship to quality assurance colleagues, with potential direct people-management responsibilities.
Requirements
Bachelor's degree or higher in Life Sciences, Chemistry, Pharmacy, or a related scientific discipline.
Between 8 and 10 years of experience in pharmaceutical quality roles, ideally with substantial exposure to clinical quality assurance and GCP compliance.
Demonstrated knowledge of global clinical research regulations, ICH GCP guidelines, health authority expectations, and quality standards applicable to clinical trials.
Experience using document control and quality management systems, such as ZenQMS, Veeva Vault, or MasterControl.
Practical experience with GCP audits, including audit planning, execution, reporting, CAPA evaluation, and follow-up.
Familiarity with regulatory inspection preparation and support, including interactions involving health authorities such as the FDA, EMA, and MHRA.
Strong understanding of clinical trial documentation, quality risk management, compliance monitoring, and root cause analysis.
Ability to interpret changing regulatory requirements and translate them into effective quality processes, policies, and operational practices.
Excellent communication and stakeholder-management skills, with the ability to collaborate effectively across clinical operations, regulatory affairs, and other cross-functional teams.
Strong analytical, organizational, and problem-solving abilities, with sound judgment and attention to detail.
Proven ability to manage competing priorities, influence stakeholders, and drive continuous improvement in a complex, regulated environment.
Leadership and mentoring capabilities, with experience guiding quality professionals and supporting a culture of accountability and quality excellence.
Benefits
Competitive annual base salary: $117,000–$189,200, depending on qualifications, experience, skills, and geographic location.
Performance-based bonus: Eligible full-time employees may receive an annual company bonus based partly on company and individual performance.
Retirement benefits: Eligibility to participate in a company-sponsored 401(k) plan and pension program.
Comprehensive healthcare coverage: Eligible employees can access medical, dental, vision, and prescription drug benefits.
Paid time off: Vacation benefits and access to certain leave programs.
Flexible benefits: Options may include healthcare and dependent care benefits, subject to eligibility and applicable plan provisions.
Financial protection: Life insurance and death benefits.
Employee well-being: Access to employee assistance programs, fitness benefits, employee clubs, and other activities.
Remote work arrangement: The position is designated as remote within the United States.
Professional development: Opportunities to strengthen clinical quality leadership, influence global compliance strategies, and contribute to continuous improvement across clinical development programs.