Associate Director, Clinical Quality Assurance

Aufgaben

• 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.

Anforderungen

• 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.

Wir bieten

• 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.

Bewerbung

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Sonstiges

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