Executive Director, Clinical QA

Clinical Qa Manager

Provides vision, strategic planning and management for departmental initiatives. Responsible for developing and setting strategy and operating plans for Clinical QA, and establishing compliance, procedures, and quality leadership. Responsible head for the Clinical QA matters for building and leading a team of highly trained and skilled quality professionals in order to implement the quality systems and perform activities necessary to ensure compliance and to ensure QA support of clinical study teams. Prepares and leads the company through pre-approval inspections and clinical audits. Coordinates interdepartmental activities both internally and externally with regulatory, clinical, drug safety, and medical affairs to ensure clinical activities and internal functions meet quality standards and reflect risk-based principals. Ensures budget, schedules, and department performance requirements are met. Additionally, mentors and coaches all employees within the QA group and provide leadership and management within the entire team.

Your contributions (include, but are not limited to) :

• Drives the strategic vision and direction for Clinical QA group
• Develops, executives, evaluates and adjusts strategy for Clinical QA and establishes strong, effective working relationships with internal and external stakeholders to achieve GCP compliance and Quality objectives
• Leads effort in developing, implementing and communicating of the GCP QA vision, goals, core capabilities, and values while championing a strong Quality Culture
• Partners with Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance, and Regulatory Affairs stakeholders regarding compliance issues and provides quality guidance and expert interpretation of GCP regulatory requirements and expectations
• Responsible for preparations and direct participation in regulatory inspections, which may include reviewing inspection readiness planning, mock inspections, performance of pre-approval inspections, and risk-based management of program inspection quality events
• Leads and project manages the development, implementation, and enhancements to the clinical QMS
• Participates in the evaluation, selection, compliance audit strategy, and oversight of global clinical investigators, contract clinical laboratories, and CROs
• Monitors the regulatory status of principal investigators and intervenes when sub-optimal performance is identified. Assists in remediation and corrective action plans to ensure all parts of the study are conducted properly
• Supports investigational new drug applications, ex-US clinical trial applications (CTA), and related correspondence from global regulatory authorities
• Develops metrics and trending of compliance activities for Clinical Quality Assurance and communicate these to upper management as necessary
• Performs investigator site and vendor audits to assess the integrity of the study data and to determine if studies are being conducted in compliance with applicable GCP / regulatory requirements and guidelines, study protocols, monitoring plans and applicable policies / procedures
• Directs and oversees compliance activities related to drug safety and pharmacovigilance, phase IV studies and investigator-initiated trials
• Oversees and may perform the internal audits designed to determine if policies / procedures, systems, reporting and / or the conduct of the investigational studies are executed with compliance to GCP principles / regulations
• Other duties as assigned

Requirements :