• Verify clinical compliance to applicable Standard Operating Procedures and regulations by performing audits.

• Promote Quality by preparing Project Specific Procedures, providing training to staff and supporting the Quality Management System.

• Host client audits, perform external audits at clinical and/or vendor sites.

• Participate in the development Corrective and Preventive Action (CAPA) plans, and contribute to resolution of audit findings, under direct supervision of the Project Lead.

• Assist with quality assurance (QA) audits (including document and process audits) per procedure.

• Develop quality-related documentation for client projects, including SOPs, work practices, forms, training materials, etc., under the direct supervision of the Project Lead.

• Assist with project management activities associated with quality projects, including maintenance of project information.

• Observe and adhere to applicable regulatory and legal requirements.

• Perform Quality Control (QC) of scientific documents and reports, as requested.

• Interact directly and with clients and demonstrate strong client interaction skills.

• Participate in company and departmental process improvement and recommend suggestions to improve efficiencies.

• Represent self and company in a professional manner and in line with core company values.

• Practice excellent internal and external customer service, communication, and teamwork.

• Support objectives and improvement efforts within department and organizationally.

• Comply with all applicable policies, procedures, and training requirements.

• Bachelor’s degree in biomedical, nursing or related life science discipline required

• 5 years of related experience or relevant pharmaceutical, health authority and/or CRO experience

• Prior experience in a Quality Assurance department required

• Provides oversight and development of Quality Management Systems (QMS)

• Familiarity with ISO 9001:2015

• Familiarity with 21 CFR Part 11, FDA, and GCP requirements

• Understanding of scientific, medical, and/ or clinical data

• Excellent, demonstrated verbal and written communication skills

• Working knowledge of QC practices

• Proficient with MS Office applications

• Excellent organizational and communication skills and detail-oriented

• Travel 15%

Job Snapshot