Title: Sr. Vendor Auditor (Auditor III/Compliance Manager) - Remote, United Kingdom - Remote, Romania - Remote, Serbia - Remote, Czechia - Remote, Bulgaria - Remote, Poland - Remote, Hungary Full time   Join us as a Sr. Auditor (Auditor III/ Compliance Manager) on the Vendor and Information System Audits Team and make an Impact at the Forefront of Innovation!   Position overview: The Sr. Auditor is responsible for conducting complex external (vendor) GxP audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines (e.g., EMA, MHRA, FDA), and client contractual obligations. The Sr. Auditor also identifies issues impacting the quality and/or integrity of clinical research programs, determining adequacy of the root cause of non-conformance and the actions to address issues. What You'll Do: - Lead and report a variety of GMP, GLP and GCP qualification and routine vendor audits, as requested by senior management, including but not limited to on-site, virtual and remote audits of service providers used in clinical trials with or without technology components - Perform directed vendor audits - Provide GxP and QA consultation and support to internal and external clients - Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings - Mentor junior staff. - Lead process/quality improvement initiatives. - Develop tools and other materials for tracking of compliance management activities and analyze trends. Required Education & Experience: - Bachelor's degree or equivalent and relevant formal academic / vocational qualification - Previous QA and GxP vendor auditing experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). - Fluency in English   Required Knowledge, Skills & Abilities: - Solid knowledge of the clinical trial process - Thorough knowledge of GxP and appropriate regional research regulations and guidelines - Demonstrated proficiency leading a wide range of GxP vendor audits to high standards - Excellent oral and written communication skills (including appropriate use of medical and scientific terminology) - Proven training/mentoring experience of staff - Strong attention to detail - Effectively works independently or in a team environment - Highly developed problem solving, risk assessment and impact analysis abilities - Solid experience in root cause analysis and CAPA development - Expert knowledge of procedural document development - Strong negotiation and conflict management skills - Proven adaptability - Strong organizational and time management skills including flexibility and ability to multi-task and prioritize competing demands/workload - Strong computer skills; ability to learn and become proficient in appropriate systems - Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel   The following is a plus: - Experience performing other types of QA audits or activities (e.g., investigator site audits, process audits, database audits, clinical study report audits, process improvement) - Experience hosting client audits and/or regulatory inspections.

• Design, create, and execute manual and automated test cases to validate software functionality. • Identify, document, and track defects in a test management or issue tracking system (e.g., Jira). • Perform functional, regression, exploratory, and API testing to ensure system stability and reliability. • Collaborate with developers and product managers to refine testing requirements. • Conduct API testing using tools like Postman, Swagger etc. • Ensure test coverage across various test levels (integration, system). • Assist in User Acceptance Testing (UAT) with customers testing teams and provide recommendations for software readiness. • Work in an Agile development environment with familiarity to Agile ceremonies, participating in sprint planning, stand-ups, and retrospectives. • Support the adoption of test automation frameworks where applicable (e.g., Identification of automation areas).

• Execute test cases and regression testing • Perform functional and usability testing • Ensure requirement coverage • Track and document defects • Support re-testing and validation • Collaborate with Senior QA on triage • Maintain test documentation • Assist root cause analysis • Participate in sprint ceremonies • Report progress, risks, blockers • Support test environments and data • Assist release and incident support

• Identify, document, and track defects, and work with the development team to resolve them. • Create, audit, and update test cases and QA documentation. • Review and test requirements during grooming before development starts. • Perform functional, regression, exploratory, and user acceptance testing. • Validate key business scenarios such as quotes, block-offs, abandoned carts, multiple quantity orders, and multiple bookings per order. • Work closely with developers, designers, PMs, and QA to understand functionality and plan testing. • Take ownership of assigned features from start to finish.