Executive Director, Quality

Position Summary:

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

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

• Provide ICH/GCP compliance guidance throughout the clinical development life cycle
• Manage Quality and Compliance functional activities, including implementation of the QMS, inclusive of SOPs, Training 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 when suspicion of suspected scientific misconduct/serious non- compliance
• 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 20 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 Form GE-001-F v01.1 Confidential Page 3 of 3 JD Template Precision for Medicine
• 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 is able to 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
• Has basic understanding of 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