Senior Director, Clinical Quality Assurance

3 days ago


New York, NY, United States Real Staffing Full time
Senior Director, Clinical Quality Assurance
Join Our Client's Team as a Senior Director in Clinical Quality Assurance

Our client is seeking a highly qualified and experienced Senior Director of Clinical Quality Assurance to lead their global CQA strategy, ensuring compliance with Good Clinical Practice (GCP) and worldwide regulations. This is a high-visibility leadership role with the opportunity to make a profound impact on clinical development and quality assurance processes in a forward-thinking, digitally transforming organization.

Key Responsibilities
  • Design, deliver, and oversee the global Clinical Quality Assurance (CQA) strategy, including audit and inspection management, issue resolution, and quality management system oversight.
  • Conduct complex audits of sites, vendors, and internal processes while mentoring and training junior auditors.
  • Champion the mission of "Quality as an enabler of business" and drive initiatives for continuous improvement.
  • Leverage data and insights to align quality strategies with clinical portfolio and business objectives.
  • Engage with regulatory bodies, industry-wide QA communities, and internal stakeholders to address emerging quality needs and trends.
  • Build and manage a high-performing team of CQA professionals to meet evolving industry demands.
Key Skills
  • Leadership: Proven ability to inspire and manage cross-functional teams and oversee multiple critical quality projects.
  • Strategic Thinking: Expertise in developing and executing CQA strategies that align with global standards and business goals.
  • Audit and Compliance: Extensive experience conducting GxP audits, ensuring compliance, and managing regulatory relationships.
  • Innovation: Proficiency in leveraging advanced analytics, digital tools, and best practices to enhance quality processes.
  • Stakeholder Influence: Adept at engaging with senior stakeholders and fostering productive collaborations.

Take the next step in your career by leading an innovative and impactful team within our client's forward-looking organization. Apply now to seize this opportunity

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

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