MMS is looking for GxP Auditors who are available as a project-based consultant.**Responsibilities**:- Plan and conduct GxP (GCP, GLP, and/or GMP) audits in the Medical Device, Biological Drug/Agent, and/or Pharmaceutical realm. Audits may include investigator site, sponsor, Mock Inspection, process, quality assurance/quality management system, software/computer system qualification and validation, vendor (including vendor qualification), and/or bioanalytical/bioequivalent/pharmacokinetic.- Report Observations and other potential concerns to the auditees and client, both through verbal presentations and written audit reports as required by the client.- Assist with the development of corrective and preventive action plans, and facilitate resolution of audit findings as required by the client.- Write confirmation letters, and audit plans, agendas, reports and other required audit documentation.- Provide drafts of required documents, and finalize following internal QA and sponsor reviews according to project timeline.- Provide GCP and inspectional preparedness training to clinical sites, vendors, and sponsors as required by client.- Provide good documentation training to auditees as required by client.- Perform gap analysis of SOPs and procedures as required by client.- Review, develop and revise client procedures, guidance documents, form templates, and quality documentation as required by client.- Perform all audit-related activities in accordance with MMS procedures and using MMS document templates, or client procedures and templates as required by the client.**Required Qualifications**:- Bachelor’s degree or higher in biomedical, nursing or related life science discipline required.- Minimum 5 years relevant auditing experience preferred.- Minimum 2 years SOP development experience preferred.- Minimum 2 years GxP training experience preferred.- Comprehensive understanding of ICH Guidelines [i.E., ICH E6 (R1) and ICH E6 (R2)], appropriate EU Directives, appropriate Titles within 21 CFR, and relevant country-specific regulations.- Training to and understanding GDPR requirements relative to clinical research preferred.- Excellent demonstrated verbal and written communication skills- Ability to travel up to 50%, both domestically and internationally.0cGmjpLwlZ