Senior Director, GCP Quality
Reporting to the Vice President, Quality and Compliance, this position will require regular interaction with senior management and executives on matters concerning the quality and compliance clinical study activities. This individual is expected to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. He/She will be expected to exercise judgment within broadly defined regulations in selecting systems and evaluation criteria for obtaining results. He/She will ensure budgets, schedules, and performance requirements are met.
To establish and manage quality standards, systems and procedures to assure the protection of clinical study subjects, study integrity and compliance with Good Clinical Practice (GCP) regulations. The position will provide quality oversight of clinical study activities.
RESPONSIBILITIES: Policies, Systems and Procedures:
• Establish and maintain appropriate policies and procedures for the conduct of Principia’s clinical studies in collaboration with Clinical and Regulatory colleagues.
• Lead, coach, facilitate, and support problem-solving, analysis of data and continuous improvement activities.
Clinical Study Participation:
• Participating in the evaluation and qualification of clinical vendors.
• Provide support and proactive strategic planning for QA oversight of clinical development activities.
• Assisting clinical development and operations in the development of training materials and conducting training.
• Investigation of significant study deviations, creatively finding solutions to complex compliance issues and management of CAPAs.
• Conduct domestic and international clinical vendor audits, participating cross functionally with internal stakeholders to assure compliance with GCP regulations and Principia Standard Operating Procedures (SOPs).
• Conduct study audits to assess compliance with GCP requirements, study protocols, manuals, plans and company standards.
• Conducting internal quality audits to assess Principia’s GCP compliance.
• Communicating audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to develop root cause Corrective and Preventive Action (CAPA) plans.
• Maintaining databases for audit observations and CAPAs.
Tracking, reviewing, approving, and assessing the effectiveness of CAPAs.
Competent Authority Inspections:
• Facilitate and assist with the preparation, coordination, and management of Competent Authority inspections of Principia and clinical vendors.
• Prepare clinical sites for Competent Authority GCP inspections.
The position requires a bachelors/masters degree in science/nursing; 15+ years of experience in clinical development with an ethical pharmaceutical company with 5+ years of auditing experience; a thorough knowledge of US and EU GCPs; ICH clinical and quality guidelines as well as 21CFR11 requirements. Candidates must demonstrate expert problem solving, organizational, planning, prioritizing, decision-making, as well as exceptional communication (written and oral), negotiation and influencing skills. Strong computer skills in applications used in a general office settings such as word processing, spreadsheets, presentations, data base management, and internet search engine applications is also required. This position may require up to 40% travel
Principia Biopharma, Inc. is an equal opportunity employer