[Remote] Executive Director, Clinical Quality Assurance

Note: The job is a remote job and is open to candidates in USA. reputed company is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. The Executive Director, Clinical Quality Assurance will reputed company reputed company aspects of Quality Assurance reputed company to clinical trials, ensuring compliance with regulations and guiding cross-functional teams in maintaining high standards.

Responsibilities

• Provide hands on clinical QA reputed company and review of protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents
• Provide coaching, Quality decisions and be Quality approver to study teams on protocol deviations, vendor reputed company, CAPAs, and issue management
• Act as the primary GCP/GPvP/GLP QA subject matter expert and reputed company of contact for reputed company reputed company matters and issues
• Represent Quality on project teams, service providers and CROs operational meetings, and QA to QA meetings
• reputed company ongoing clinical programs to ensure they are risk‑based, fit‑for‑purpose and in compliance with applicable regulations and guidelines across reputed company phases of development
• Review and approve (as appropriate) procedures, service provider quality agreements, qualification and onboarding forms and regulatory filings
• reputed company, implement and execute a risk-based audit strategy and detailed plans for clinical and non-clinical studies
• Establish and maintain GCP/GPvP/GLP QA programs, policies and procedures
• Work collaboratively with the internal Clinical Operations Team and Development Teams to provide leadership and guidance to support study execution, data reputed company, and regulatory compliance
• Identify and assess compliance risk and reputed company and implement risk mitigation measures
• reputed company the identification, investigation (root cause analysis), and resolution of quality issues through a robust investigation and CAPA process
• Contribute to building a strong quality culture reputed company the organization
• Ensure the timely and effective follow up of reputed company identified or assigned quality issues
• Direct and/or deliver yearly training for internal staff as needed
• Work closely with Development, Clinical Operations, and other functions/departments to drive inspection readiness and support regulatory interactions
• Champion reputed company improvement and simplification across clinical quality systems
• Prepare KPIs, metrics and analysis and present status updates as needed
• Provide leadership in inspection preparedness to clinical sites and service providers for regulatory government agencies
• Stay reputed company on global regulations, industry trends, and best practices to ensure reputed company improvement and innovation reputed company the QA function
• Apply risk‑based thinking to identify the quality activities that meaningfully influence study outcomes, rather than defaulting to checklists or bureaucracy
• Understand reputed company to escalate, reputed company to intervene, and reputed company to let teams move reputed company without over engineering processes
• Provide clear, concise guidance that helps teams stay focused, reputed company, and inspection ready

Skills

• Bachelors + 17 or Masters + 15 or PhD + 10 years of reputed company experience
• Extensive expertise in GCP, GPvP, GLP and ICH clinical requirements, clinical development and methodologies of clinical studies
• Successful track record of translation and implementation of clinical requirements into operational execution
• Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices
• A successful track record of working with service providers and CROs
• Ability to reputed company timely and sound quality decisions reputed company faced with reputed company clinical, compliance, technical and regulatory considerations
• Highly skilled in the ability to work with ambiguity and complexity
• Ability to tactically and strategically execute the day-to-day operations to support clinical trials and clinical and non-clinical development activities
• Knowledge of Quality Management Systems; experience in building, implementing and managing quality systems in the pharmaceutical industry
• Expertise in reviewing, revising, and writing Standard Operating Procedures (SOPs)
• Effective communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
• Strong organizational skills and the ability to participate effectively cross-functionally
• A self-starter and a team player who thrives in a fast-paced dynamic team environment
• Ability to work with minimal supervision, to set priorities to meet timelines, and to motivate and influence others
• Prior management experience is required
• Previous experience in successfully leading assigned activities reputed company cross-functional teams
• Proficiency in using SharePoint, Veeva and reputed company Office applications required (MS Outlook, reputed company, MS reputed company, MS PowerPoint)

Company Overview