Associate Director, CSV Auditing at Jobgether – United States
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About This Position
This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Associate Director, CSV Auditing in the United States.
This role is a senior leadership position within quality assurance, focused on overseeing Computer System Validation (CSV) auditing programs in support of global clinical development operations. The Associate Director will lead risk-based auditing activities, ensuring compliance with regulatory requirements and internal quality standards. This position involves mentoring and developing audit staff, optimizing audit methodologies, and collaborating with cross-functional teams to ensure audits are effectively planned and executed. The role requires strategic oversight of both internal and external audits, regulatory inspection readiness, and continuous improvement of auditing processes. With a combination of technical expertise, leadership, and global coordination, the position contributes directly to the integrity and compliance of critical systems and processes.
- Lead the development and execution of CSV auditing programs, including planning, conducting, reporting, and follow-up of audits in compliance with GxP standards.
- Provide strategic guidance for audit methodologies and standards, ensuring they remain current with evolving technologies and clinical development practices.
- Manage internal and external audits globally, including oversight of high-priority regulatory inspections and related compliance projects.
- Supervise, mentor, and train auditing staff, fostering professional development and maintaining a high-performing team.
- Collaborate with cross-functional teams to assess audit needs, prioritize projects, and support organizational risk management objectives.
- Prepare and deliver metrics and reports to management and stakeholders to drive continuous improvement in audit quality and efficiency.
- Act as a subject matter expert and resource for regulatory inspection readiness and compliance initiatives.
Requirements:
- Bachelor’s degree required; Master’s degree preferred in a relevant scientific or technical field.
- Minimum of 11 years of relevant experience, including at least 9 years in auditing CSV systems and 3 years in a management or leadership role.
- Demonstrated expertise in FDA, EU, and ICH regulations, with experience in GCP, GLP, and GVP audit programs.
- Experience with regulatory inspections of Investigator Sites, Sponsors, or CROs.
- Strong leadership, mentoring, and team development skills.
- Excellent analytical, problem-solving, and decision-making capabilities.
- Ability to communicate complex technical and regulatory information effectively to diverse audiences.
- Willingness to travel 30–40% domestically and internationally.
Benefits:
- Competitive annual salary range: $157,200 - $256,600.
- Comprehensive health, dental, vision, and life insurance coverage.
- Retirement savings plan with employer matching contributions.
- Paid time off, parental leave, and flexible work schedule options.
- Professional development opportunities and training programs.
- Participation in equity awards and annual bonus programs.
- Support for global travel and remote work as needed.