QA Auditor II, Vendor Auditor

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Lead and/or perform various GxP qualification and routine vendor audits as requested by senior management, which may include on-site, virtual, and remote audits of service providers involved in clinical trials with or without technology elements.

• Execute directed vendor audits.

• Potentially conduct clinical investigator site audits.

• Offer GxP consultation and support to both internal and external clients.

• Act as a knowledgeable resource for operational departments on audit or quality assurance topics.

• Prepare and present audit findings and relevant information during departmental, internal operations, or client meetings.

⛳️ Requirements

• A bachelor's degree or equivalent formal academic/vocational qualification.

• Prior experience in QA and GxP vendor auditing that equips the candidate with the necessary knowledge, skills, and abilities to perform the role (typically 3+ years).

• Proficiency in English, Spanish, and Portuguese.

• Strong understanding of the clinical trial process.

• Comprehensive knowledge of GxP and relevant regional research regulations and guidelines.

• Proven ability to conduct a range of GxP vendor audits to the high standards expected by management.

• Exceptional oral and written communication skills, including the correct use of medical and scientific terminology.

• Keen attention to detail.

• Strong organizational and time management skills, with the flexibility to multitask and prioritize competing demands/workload.

• Possess a valid driver's license and the ability to qualify for and maintain a corporate credit card with an adequate credit line for business travel.

🏝️ Benefits

• Health insurance.

• Paid time off.

• Opportunities for professional development.