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 Team help counsel on and direct quality initiatives to provide ICH/GCP compliance guidance throughout the clinical development life cycle enhance/ensure quality is assessed and maintained cross-functionally. 
•  Support and enhance Precision’s Corporate Compliance functions and facilitate business development and proposals for these areas as the need arises, including bid defense meetings and project kick-off meetings.
• Lead system, site, documentation & Trial Master File audits to ensure compliance with internal SOPs/project plans and industry standards.
• Review/audit documents intended for submission to the FDA to assure compliance with regulatory standards.
• Build upon the current QMS in establishing additional company standards and metrics to ensure the highest quality of services provided to clients.
• Participate in leading, maintaining and executing the corporate quality initiatives within Precision for Medicine.
• Maintains current knowledge of regulations and guidance documents, providing expert analysis to project teams

Qualifications:

Minimum Required:

• Requires 15 years of experience in clinical research with emphasis in Quality Assurance / Compliance
• Working knowledge of GCP/ICH guidelines and FDA regulations and standards
• Supervisory/management experience leading quality personnel

Other Required:

• Bachelor’s degree in a science, healthcare or related field of study
• Availability to travel up to 25% domestically and/or internationally
• Experience leading audits

Preferred:

• Graduate, postgraduate degree, ideally in a scientific or healthcare discipline
• CRO, Pharmaceutical and/or medical device experience
• Experience hosting client/Health Authority inspections

Skills:

• Strong leadership skills, excellent interpersonal and problem-solving skills, strong verbal and written communication, excellent computer skills
• Clinical project proposals and budget forecasting Competencies:
• Ability to effectively communicate across the organization on quality topics
• Represents Quality in sponsor discussions
• Demonstrates mastery knowledge of GCP/ICH guidelines, FDA regulations and Precision SOPs
• Resolves project related problems and prioritize workload to meet deadlines with little support from management
• Exhibits high self-motivation and can work and plan independently as well as in a team environment
• Motivates other members of the project team to meet timelines and project goals
• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
• Ability to review and evaluate clinical data
• Proven ability to communicate with senior management, external thought-leaders and operational staff
• Advanced proficiency in Microsoft Word, Excel, and PowerPoint, and some knowledge of Access or similar database
• Understands financial management to review proposals and budgets
• Must possess a customer service demeanor; demonstrate collaboration and flexibility, teamwork, and a keen attention to detail
• Ability to work with cross functional groups and management under challenging situations
• Ability to prioritize work and handle multiple and/or competing assignments
• Excellent verbal and written communications skills
• Fluent in English language

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