Senior Director, Clinical Quality Assurance

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver strategic and operational leadership in Quality Assurance for various registrational, global 4DMT-sponsored clinical trials.

• Act as a senior Quality partner to clinical study teams and executive leadership, offering guidance on Good Clinical Practice (GCP), ICH E6, relevant regulations, decision support, and recommendations for escalation.

• Spearhead the creation, implementation, and governance of Clinical Study Quality Plans.

• Oversee, mentor, and develop Clinical QA personnel and consultants.

• Define, plan, conduct, and/or supervise risk-based GCP compliance audits of high-risk clinical vendors and sites.

• Communicate audit results, identify quality risks, and manage CAPA commitments; evaluate CAPA adequacy and escalate any unresolved or recurring issues.

• Provide senior Quality review and strategic input on clinical and regulatory documentation.

• Direct the investigation and management of significant Clinical Study Quality Events and supervise corrective and preventive actions.

• Collaborate with CMC Quality, Clinical Operations, and senior cross-functional stakeholders to address clinical supply quality challenges.

• Supervise GCP compliance training and enhance the clinical quality culture and inspection preparedness.

• Partner with Clinical Operations, Clinical Development, Biometrics, Data Management, Medical Affairs, and Regulatory Affairs for proactive quality and risk management.

• Lead the development and continuous enhancement of the Clinical Quality Management system.

• Define and direct the GCP inspection readiness strategy, including mock inspections, logistics, and issue escalation.

• Host, lead, and/or provide senior Quality support for inspections related to GCP.

⛳️ Requirements

• A Bachelor's degree in a life science, nursing, pharmacy, or a related discipline.

• Over 12 years of experience in a regulated environment such as Regulatory, Quality, Pharmacovigilance, or Clinical Development/Operations within the Biotech industry or similar, or an advanced degree with at least 10 years of experience.

• A minimum of 7 years of substantial experience in clinical quality assurance.

• Demonstrated experience in leading Clinical quality strategy, ensuring quality governance, and providing senior-level oversight for global clinical trials and associated vendors.

• Background in hosting, leading, and supporting health authority inspections, including preparation for inspection readiness, front-room/back-room assistance, response coordination, and management of follow-up commitments.

• Extensive hands-on experience and comprehension of clinical quality assurance throughout the clinical development lifecycle.

• Proven capability to influence senior cross-functional stakeholders, lead intricate clinical quality initiatives, and provide mentorship or functional leadership within Clinical QA.

• In-depth understanding of GCP requirements for investigational products, with the ability to interpret and strategically apply these requirements across clinical programs.

• Excellent oral and written communication skills at the executive level.

• Strong leadership, influencing, and interpersonal abilities, combined with a collaborative approach.

• Capacity to work independently in a fast-paced, small company environment, prioritize complex tasks, make risk-based decisions with minimal guidance, and adapt swiftly to changing priorities.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and holiday schedule.

• Opportunities for professional development and career advancement.

• A collaborative and innovative work environment.