Senior Director, Clinical Compliance / Inspection Readiness

Highly Competitive
  1. Permanent
  2. Program Manager / Director
  3. United States
Cambridge, USA
Posting date: 28 Mar 2025
64901

Senior Director - Permanent - Cambridge, MA

Proclinical is seeking a Sr. Dir. to join the Clinical Operations team with a focus on Clinical Compliance and Inspection Readiness.

Primary Responsibilities:

The successful candidate will be involved in leading compliance activities to ensure programs are always prepared for inspections.

Skills & Requirements:

  • In-depth experience with CP, Regs., and quality systems.
  • Bachelor's degree or equivalent in a relevant field.
  • Experience in global clinical trials and operations.
  • Proficiency in audit preparation, execution, and follow-up, including CAPA.
  • Familiarity with computerized clinical trial records management technologies, particularly Veeva systems.
  • Strong organizational, writing, and communication skills.
  • Advanced knowledge of ICH/GCP guidelines and FDA regulations.

The Senior Director's responsibilities will be:

  • Develop and deliver GCP and Inspection Readiness training for the Clinical organization.
  • Implement processes and tools to maintain inspection readiness.
  • Provide inspection readiness support and expertise to study teams, including risk mitigation.
  • Prepare and execute plans for audits and regulatory inspections.
  • Represent Clinical Compliance in audits and inspections, supervising preparation activities.
  • Coordinate follow-up on audits, inspection responses, and corrective actions.
  • Generate and communicate compliance and inspection readiness metrics.
  • Drive continuous improvement in inspection readiness and conduct support.
  • Develop controlled documents related to clinical study processes in compliance with global standards.
  • Execute strategy for role-based curriculum and GCP training.
  • Conduct compliance assessments and collaborate with Quality Assurance.
  • Manage follow-up on audits and implementation of corrective actions.
  • Provide training on Clinical Standard Operating Procedures to ensure regulatory compliance.

If you are having difficulty in applying or if you have any questions, please contact Nico Kohlwes at n.kohlwes@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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