Director, Global Clinical Quality

Premier Research•Regional_NC, NC

4d•$151,000

About The Position

Premier Research is looking for a Director, Global Clinical Quality to join our Global Quality team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

Requirements

Bachelor’s degree in Life Sciences or related field
5-7 years in a lead Operations role at a clinical site/system research facility
5-7 years of industry experience in a Quality leadership role
Strong knowledge of ICH-GCP, FDA, ISO, and other global regulatory requirements
Expert in Risk-Based and Critical to Quality Strategies at the clinical trial level throughout the project lifecycle
Must demonstrate strong computer skills and be able to embrace new technologies.
Demonstrated Leadership and mentorship capabilities in leading teams with a proactive, Quality by Design approach to deliverables

Nice To Haves

Mastery of Analytical Data Visualization Tools and techniques preferred

Responsibilities

Ensures that each BU Quality Lead performs individual protocol assessments, Critical to Quality data and process, safety, and data integrity risks related to protocol startup, execution and close out, develop and implement ongoing initiatives to assess potential clinical quality risks, including data integrity issues and drive identification, mitigation and prevention.
Identifies/facilitates key quality improvements and innovation.
Drives vision of continuous state of regulatory preparedness
Supports and mentors the operational teams from a Quality perspective
Works with Risk Based Quality Management oversight leaders from operational teams in development of initial risk assessments and identification guidance for potential study specific risks, leads/mentors both Quality and Operational Leads in evaluation, mentors Quality and Operational teams in collaboration with Clinical leadership in implementing a systematic approach to corporate and clinical governance, risk management policy,
Ensures the immediate communication and escalation of serious issues and signals of concern to the project team and mentors the operational team through the development of action plans.
Oversees the documentation of observations noted during reviews, investigates trends, issues and risks for root cause.