Location: Philadelphia, PA
- Serve as senior Testing Facility Management and direct all aspects of CMSC nonclinical studies performed according to FDA GLP regulations (21 CFR Part 58), ensuring adherence to these requirements.
- Assure senior leadership, study sponsors, and regulatory inspectors that facilities, personnel, practices, and records are compliant with FDA GLP regulations.
- Ensure a complete portfolio of GLP policies and procedures are established and adhered to by study personnel.
- Analyze complex situations and effectively communicate situations/issues, along with potential recommendations, to various functional groups with diplomatic and objective representation of the issue(s) where there is no precedent.
- Provide strategic direction to leadership through goal alignment.
- Support filing activities for and communications with regulatory agencies, including representing the site ring agency inspections.
- Ensure that facilities are maintained inspection ready, including all related elements such as documentation, reports, and records.
- Collaborate across functions to drive study conduct excellence, share best practices, and lessons learned.
- Potentially provides services after regular business hours, weekends, and holidays.
- Education Qualifications: Bachelor’s Degree Required, Master’s Degree Preferred
- At least ten (10) years of related compliance, quality or facility experience in an FDA GLP compliant setting Preferred
- At least seven (7) years of leadership, management or supervisory experience Preferred
- Prior experience with gene and/or cell therapy initiatives, preferably in the field of neurobiology Preferred
- Large animal GLP study is Preferred
- Possible Hybrid job but will need to be on site for certain project milestones and meetings