Senior Technology Auditor, QA

🕒 August 7

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Independently lead, plan, schedule, perform, and report GxP audits across clinical research phases • Conduct project, system, process, supplier qualification/re-qualification, TMF, GMP, GLP, GCLP, and safety/pharmacovigilance audits • Deliver high-quality audits and audit reports within specified timelines and budgets • Lead or participate in complex, for-cause, co-audits, and observed audits • Develop and execute strategic audit plans for assigned areas of specialization • Collect, review, and escalate responses to audit findings and oversee CAPA implementation • Lead and coordinate global and regional internal audit programs • Develop audit tools, report templates, checklists, and standard communications • Report audit-program outcomes and trends to process owners and QA Senior Management • Act as QA lead for contracted audit programs and maintain client relationships • Support serious-breach investigations and reportability determinations • Train and mentor new or less experienced auditors • Maintain QA records, systems, tools, and audit documentation • Support audit planning, metrics, process improvements, sponsor audits, and regulatory inspections • Provide regulatory compliance consultation on GxP and safety/PV requirements • Review Parexel SOPs for GxP compliance and maintain training compliance • Build relationships with internal and external customers and collaborate with operational staff • Perform other quality-related tasks and initiatives as assigned

🎯 Requirements

• Minimum of 4 years’ experience in quality assurance and auditing, including sound GxP auditing experience • At least 7 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, technology, third-party supplier management, or another relevant life-science area • Degree-level education in technology, biological science, pharmacy, or another health-related discipline, or equivalent qualification or clinical research experience • Master’s degree in a science, technology, or industry-related discipline preferred • Excellent knowledge and experience of Good Practices (GxPs) and international, national, and local clinical-trial regulations and laws • Ability to learn and apply Parexel and client procedures and computer systems • Experience with Microsoft Office and other computer systems/software • Ability to work flexibly across multicultural environments and in a matrix organization with multiple supervisors • Excellent interpersonal, verbal, written communication, presentation, mentoring, and training skills • Strong organizational, analytical, problem-solving, decision-making, negotiation, and time-management skills • Ability to work independently in a fast-paced environment and manage multiple projects • Detail-oriented, critical-thinking, and big-picture analytical abilities • Ability to handle confidential and sensitive information diplomatically and professionally • Team leadership abilities and a positive attitude • Willingness to travel internationally for audits, potentially up to approximately 60% of travel time

🏖️ Benefits

• International travel for audits as required, potentially up to approximately 60% of travel time • Training and mentoring opportunities through co-audits, training delivery, and knowledge sharing • Opportunity to work with a global clinical research organization and multicultural teams