MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.
This is a project-based consulting position.
- Plan and conduct GxP audits in the Medical Device, Biological Drug/Agent, and/or Pharmaceutical realm. Audits may include Mock Inspection, process, quality assurance/quality management system, software/computer system qualification and validation, vendor (including vendor qualification), facilities management, process validation, packaging/labeling, quality control, batch review and acceptance, shipping and distribution, and/or depot.
- Provide GxP and inspectional preparedness training as required by client.
- 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 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.
- Must be able to read and write Spanish in addition to English.
- 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.
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