Associate 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 an Associate Director, GCP Quality and Compliance today?

Position Summary: 

The Associate Director, Quality supports the audit program and clinical projects to ensure compliance with regulations and Precision procedures.

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

• Work closely with the Quality and Compliance management/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.
• Lead the oversight of a Quality Management Systems inclusive of SOPs, Training and CAPAs.
• Support and mentor Quality & Compliance team members
• 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.
• 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.
• Other duties as assigned

Qualifications:

• Minimum Required:
  • Requires 8-10 years of experience in clinical research or pharmaceutical development with emphasis in Quality Assurance/Compliance or equivalent relevant experience and/or demonstrated competencies
  • Working knowledge of GCP/ICH guidelines and FDA regulations and standards
• Other Required:
  • Bachelor’s degree in a science, healthcare or related field of study
  • Availability to travel up to 25% domestically and/or internationally
• Preferred:
  • Graduate, postgraduate degree, ideally in a scientific or healthcare discipline
  • CRO, Pharmaceutical and/or Medical device experience 
  • Supervisory/management experience

Skills:

• Strong leadership skills, excellent interpersonal and problem-solving skills, strong verbal and written communication, computer skills

Competencies:

• Demonstrates mastery knowledge of GCP/ICH guidelines, FDA regulations and Precision SOPs
• Motivates other members of the project team to meet timelines and project goals
• Ability to review and evaluate clinical data
• 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
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment
• 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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