Director – Clinical Quality

Director – Clinical Quality

Requirements

• A Bachelor of Science (B.S.) in a scientific or technical discipline is required.
• Minimum of 15 years of pharmaceutical clinical quality assurance experience providing quality oversight and supporting multiple late-stage clinical studies (Phase II to III).
• Extensive knowledge of relevant ICH E6, FDA, EMA, HC and PMDA and other regulatory requirements and guidance documents, with practical application and execution of GLP and GCP requirements.
• Experience with the application of phase-appropriate quality systems across the product development lifecycle (Phase 1 through Phase III).
• Experience in regulatory inspections and in dealing with regulatory agencies throughout the drug product approval process.
• Professional and respectful communication skills (verbal / written).
• Ability to effectively communicate with business partners and third-party clinical vendors and their quality assurance representatives to ensure RevMed requirements are met and to resolve issues/discrepancies.
• Oral and written presentation skills are needed to address colleagues at all levels of the organization, e.g., internal training presentations, presentations of CRO performance metrics, and coordination of inspection readiness activities.
• Ability to work on multiple projects, manage competing priorities, and collaborate cross-functionally in a dynamic fast-paced environment.
• Ability to contribute to the development, performance monitoring, and continuous improvement initiatives related to the company’s Quality Systems and their associated processes, policies, and procedures.

Responsibilities

• Act as the study lead for Phase 3 program(s), provide support and guidance to the Clinical Development and Clinical Operations functions, including but not limited to the following functional areas: Global Patient Safety, Translational Medicine, and Data Management.
• Lead the development and maintenance of applicable GCP Quality Systems procedures that comply with applicable GCP standards and guidelines.
• Work with Quality Leadership to develop a risk-based GCP audit program and compliance strategy for RevMed clinical study programs.
• Manage external GCP auditors and support timely review of audit reports and communicate findings to auditees, cross-functional representatives, and management. Ensure the corrective and preventative action (CAPA) plans adequately address findings and root causes, including effectiveness checks where appropriate.
• Support global regulatory, due diligence and partner inspections at Sponsor including preparing the site, training the staff on regulatory inspection management best practices.
• Represent Clinical Quality during global regulatory inspections at RevMed including supporting regulatory inspections at clinical sites for RevMed clinical studies.
• Oversee study documentation including TMF for accuracy and inspection readiness.
• Perform quality reviews of Clinical Study Documents with a focus on compliance / regulatory requirements and risk assessment. The study documents include but are not limited to: Study Protocols, ICFs, Annual Reports (e.g., DSUR), other subject-facing documents (brochures, recruitment materials), Investigator’s Brochure, and CSR.
• Escalate quality events, IPDs, potential serious breaches to Quality Management and other relevant leadership as needed and in a timely manner including initiating CAPAs and CIs to address major findings and gaps.
• Compile, track GCP quality metrics (KPI) and vendor performance on all RevMed initiated clinical studies and report to quality management on a quarterly basis.
• Partner with GLP team members on activities that may impact GCP studies/data.
• Perform other assigned GCP or GXP tasks, as appropriate.
• Manage a team of clinical QA professionals and contractors and mentor QA staff.
• Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.

Preferred Qualifications

• Experience managing oncology clinical studies and 4+ years of GLP quality assurance experience is preferred.
• An advanced degree is a plus.