Associate Director Clinical Compliance
Philadelphia Metro Area, Pennsylvania
- BS or advanced degree in scientific, healthcare or related with a minimum of 8 years pharmaceutical industry including 5+ years in Clinical Compliance, quality, training or related clinical functions.
- Knowledge of clinical auditing and operations is required
- Advanced understanding of ICH GCP, FDA Regulations and EU Clinical Trial Directives; thorough knowledge of the drug development process, device experience a plus
- 5+ years of management experience, including management, development and mentoring
- Responsible for the management and execution of activities associated with clinical procedural development and maintenance, clinical training programs, inspection preparedness, and assessment and investigation of clinical quality compliance issue and oversight of clinical vendor qualification assessments.
- Oversight of the clinical compliance staff
- Manage and oversee development and approval of controlled documents related to clinical study processes and systems including Policies, SOPs, Work Instructions and related
- Manage follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of CAPAs