Contractor GLP Auditor, QA R&D Nonclinical

The Consultant, Research & Clinical Development QA, Nonclinical Quality will be responsible for providing assistance to the Quality Assurance Unit in their GLP oversight of the general Quality Systems and nonclinical studies conducted at Sarepta, OH GTCOE site.

Additional assistance in support of quality oversight of clinical assays and assay validations is also included. This position will liaise with the Genetic Therapies Center of Excellence (GTCOE) personnel, as well as other Sarepta groups in an effort to ensure a high level of quality and consistency across the Sarepta platform;

assist the GLP / GCLP team in identifying and implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance.

This position will participate in inspection readiness activities and audits, as appropriate. This position will report to the Director, Nonclinical Quality, Research & Clinical Development Quality Assurance (R&CD QA).

Primary Responsibilities Include :

• Conduct protocol and protocol amendment reviews, in-study inspections, and data and report audits for nonclinical, method validation, and clinical sample testing studies for compliance to applicable regulations (GLP, GCP), methods, and SOPs.
• Perform facility inspections to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with GLP regulations.
• Review other controlled documents, e.g., Test Methods, and select SOPs and Policies, as requested by Testing Facility Management.
• Review of quality events associated with the site GLP activities including deviations, investigations, CAPAs, quality metrics.
• Support internal, Sponsor or regulatory inspection activities at the Sarepta OH site

Desired Education and Skills :

• BS / BA Degree in a scientific discipline. Advanced degree preferred.
• 5+ years experience in a related regulated industry
• 2+ years in a GLP or clinical laboratory Quality Assurance or Quality Control role.
• Technical knowledge of nonclinical GLP studies and bioanalytical and clinical test method validations
• Technical knowledge of preclinical / clinical laboratory operations and animal facility operations.
• Excellent organizational skills; ability to work independently and in team environments;
• Demonstrated understanding of FDA and Global GLP / GCP / GCLP requirements and guidance documents, ability to apply to day to day operations.
• Familiarity with Good Documentation Practices
• Experience working with document control systems and electronics QMS preferred
• Experience with reviewing Corrective and Preventive Actions, Laboratory Investigations and Deviations preferred

LI-Hybrid

This position requires work on site at one of Sarepta’s facilities in the United States.