Director, GCP Quality and Compliance

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won’t you join us today as a Director, GCP Quality and Compliance today?

Position Summary:

The Director, Quality & Compliance provides management and oversight to Quality staff, manages the audit program, supports CAPA management and supports clinical projects to ensure compliance with regulations and Precision procedures.

Essential functions of the job include but are not limited to:

• Participates with senior management to establish strategic plans and objectives. Makes final decisions on implementation and ensures operational effectiveness. 
• Effectively cascades functional strategy and contributes to development of organizational policies. Master of core functional area and how it fits within the company and competitive environment.
• Provide ICH/GCP compliance guidance throughout the clinical development life cycle.
• Works on complex issues where problems are not clearly defined and where fundamental principles do not fully apply. Translates business segment strategy into functional plans and guides execution.
• Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people.
• Ensures budgets and schedules meet corporate requirements.
• Interacts with senior management, executives, and/or major customers which frequently involves negotiating matters of significance to the organization. Reconciles multiple stakeholder views to drive business results.
• Manage Quality and Compliance functional activities, including implementation of the QMS, inclusive of SOPs, Training, Audits and CAPAs.
• Work closely with the Quality and Compliance staff and Operations to provide strategic compliance development advice and guidance for optimal conduct of clinical trials and performs ICH/GCP quality reviews/audits to ensure overall compliance with applicable regulations
• Initiate the process of follow-up for suspicion of suspected scientific misconduct/serious noncompliance.
• Supervisory responsibility of Quality & Compliance employees.
• Audit regulatory documents for submission to the Food and Drug Administration (FDA) and global regulatory authorities (e.g. MHRA).
• Provide ICH/GCP guidance, auditing advice and training to internal and external clients.
• As part of the Management …