I’m pleased to be partnering a growing clinical trials services company who are looking to strengthen their Quality team in the US. They gave gone through an exciting acquisition and now have the foundation they need to take their company to the next level and to become one of the leaders in their field.
They are searching for a Regional QA Lead / Associate Director to be responsible for ensuring global compliance and continuous audit readiness resulting in seamless clinical results reporting to internal and external customers. This role will also have line management responsibilities for a small team and will look to expand in the near future.
- Drive continuous improvement and compliance of Quality Management System (QMS) processes through the design and periodic review of metrics and key performance indicators.
- Lead process improvements and efficiencies including development and management of CAPA process and facilitation of Root Cause Analysis.
- Manage organization and hosting of Sponsor audits and Regulatory Audits/Inspections, including follow-up of resolution plans.
- Manages adequate review and analysis of incoming issues and complaints, follow-up and tracking of ongoing CAPAs from internal/external audits.
- Manages and develop the team members in direct report.
- Provides guidance and mentoring to direct reports with the goal of supporting both business deliverables and career path objectives.
- At least 8 years of quality assurance experience, including prior auditing experience in the pharmaceutical and/or Biotech industries.
- University degree (life science or other) or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities.
- Knowledge of the clinical trials process, FDA regulations and ISO quality principles.
- Strong organizational, time-management, analytical and decision-making skills.
- Must be highly detail oriented. Strong verbal and written communication skills, including the ability to positively influence the behavior and performance of staff and to positively impact the decision-making of staff, peers and superiors.
- Strong supervisory, training, coaching/mentoring, team building, facilitation and leadership skills to fully equip/engage staff to accomplish work goals in a fast-paced and changeable work environment.
- Experience with lean principles, six sigma and Risk Management is preferred.
- 10-15% travel
For more information on this opportunity, contact Alex Coppen!