VP - Regulatory Affairs and Quality Management

6 days ago

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Catalyst Clinical Research

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Listen, Devise, Breakthrough

Clinical Operations Services • Clinical Resourcing/Staffing • Clinical Teams • Functional Service Provider

201 - 500

Description

• Lead and oversee regulatory and quality functions at Catalyst. • Ensure compliance with international regulatory standards and drive quality initiatives. • Collaborate with senior leadership and regulatory bodies to maintain quality standards. • Implement and maintain Quality Management Framework and QMS at Catalyst. • Develop regulatory strategies and monitor changes in regulatory environments. • Oversee Quality Management Systems and drive continuous improvement initiatives. • Lead quality input on contracts and manage Quality Event and CAPA processes.

Requirements

• Certification or membership to a Quality or Regulatory Association is preferred but not required. • Proficient with Microsoft Office Suite. • Excellent written and oral communication skills. • Excellent presentation skills. • Strong organizational, problem-solving, and analytical skills. • Ability to manage priorities and workflow. • Versatility, flexibility, and a willingness to work within constantly changing priorities. • Proven ability to handle multiple projects and meet deadlines. • Strong interpersonal skills. • Ability to deal effectively with a diversity of individuals at all organizational levels. • Commitment to excellence and high standards. • Creative, flexible, and innovative team player. • Ability to work independently and as a member of various teams and committees. • Good judgement with the ability to make timely and sound decisions. • In-depth knowledge of global regulatory requirements and quality standards.