{"id":1226875,"url":"https://alion.io/job/parexel-senior-technology-auditor-qa","title":"Senior Technology Auditor, QA","company":{"id":2735,"name":"Parexel","domain":"parexel.com","url":"https://alion.io/company/parexel","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":81,"open_postings":44,"ghost_share":0,"stale_share":0.955,"repost_share":0,"time_to_fill_p50_days":15,"computed_at":"2026-10-28T05:59:10Z"}},"role":"Security","role_family":"Security","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Hyderabad, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":17000,"max_usd":36000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":11},"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GLP","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-09-23T18:52:14Z","employer_posted_date":null,"last_verified_at":"2026-09-23T18:52:14Z","board_verified":false,"closed_at":null,"days_open":34,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":34},"description":"Key Accountabilities\n\nLead, Perform and Report audits\n\nIndependently lead, plan, schedule, perform, and report a range of GxP audits across all phases of Clinical Research which may include but are not limited to project related audits, system and process audits, supplier qualification and re-qualification audits (including GMP & GLP as well as GCLP accreditation audits), Trial Master File audit, safety/pharmacovigilance (PV) audits in order to evaluate the quality system against the appropriate regulatory requirements, relevant procedures and applicable guidelines.\nPerform and deliver high quality audits/audit reports within specified timelines / budgets, independently or with limited oversight. Lead or participate in complex audits including for-cause audits/ co-audits / observed audits with client representatives or other QA auditors.\nAbility to review and, if necessary, identify improvements that enhance the quality and clarity of audit reports.\nFor area of specialization, work with internal customers and develop and execute strategic audit plans for the area.\nTravel internationally for audits as required. Travel time could be up to approx. 60%.\n\nManage GxP audits\n\nCollect and review responses to audit findings and follow-up ! escalate inadequate or delayed responses as necessary to ensure timelines are met and responses of satisfactory quality are obtained and formally recorded.\nAct as point of consultancy for Operations and Quality with regards to the implementation of adequate CAPAs with effective and timely escalation of relevant Quality Events where required.\n\nLead and coordinate internal audit programs (global and regional)\n\nCoordinate internal global process/system audits across regions and develop all necessary tools such as report templates, checklists and standard emails.\nReport outcome and trends of audit program to the process owner, QA Senior Management.\nEscalate quality and compliance issue trends to QA Senior Management and relevant operational functions\nResolve program related issues in a constructive and pro-active way.\nEnsure required audits are performed and reported in accordance with Parexel QA requirements, and on time.\nReview audit reports, responses and other program deliverables to ensure consistent high quality.\n\nBillable Audits/Audit programs & Client Relationships (where applicable)\n\nAct as QA Lead on audits program(s)\nArrange meetings with client and other key stakeholders as required to plan a program of contracted audits.\nEnsure required audits are delivered in accordance with clients requirements and Parexel! client procedures as applicable.\nEnsure that systematic issues raised during billable audits are escalated and addressed.\nMaintain relationships with clients and ensure audits programs are managed to a high degree of client satisfaction.\nSupport client QA needs and identify areas where billable services may be offered.\nDevelop and optimize new and existing processes to maintain and improve quality within the billable group.\n\nSupport Serious Breaches\n\nSupport Serious Breaches (SB) investigations and help oversee the project teams to reach final conclusion regarding the reportability of a critical Quality Event.\n\nSupport auditor training and Mentoring\n\nSupport the training and mentoring of new / less experienced auditors by performing co-audits, delivering training, and sharing knowledge and experience.\nAssist in developing training materials, auditing tools, templates and guidance\n\nMaintain QA records / systems\n\nProvide QA Senior Management with informational reports upon request on assigned areas\nMaintain required QA tools and ensure Parexel and QA systems are regularly updated with accurate information for audits and other activities.\nMaintain current records / documents related to assigned areas\n\nProcess improvements\n\nOptimize new and existing processes to maintain and improve quality standards including supporting quality initiatives as assigned\nSupport QA Management in development of audit plan, to analyze audit activities and provide metrics to relevant parties (QA, Operations, Procurement).\nProactively recognize areas for process / procedural improvements, providing input to QA management and taking the initiative, as appropriate.\n\nProvide local, regional and global consultancy\n\nProvide consultation and interpretation on regulatory compliance to internal/external clients, Parexel management, and staff with regards to the implementation of GxP and safety/PV requirements, and implementation of appropriate regulatory requirements.\nSupport the development, maintenance, review and improvement of Parexel procedures, systems and tools by providing constructive ideas and suggestions.\nProvide input on QA planning including audit planning and strategy as requested.\n\nSupport Sponsor Audits and Regulatory Inspections\n\nFacilitate client audits / regulatory inspections, as assigned.\nLiaise with external industry and regulatory inspectorate contacts and networks to determine best practice with regard to implementation of relevant GxP requirements across the Parexel Corporation\n\nMaintain sound knowledge of Parexel policies, procedures, and guidelines and promote compliance within Parexel\n\nWorking knowledge and expertise of Parexel policies, procedures, and guidelines, as well as applicable national and international regulations and requirements; able to apply them as needed.\nProactively recognize areas for process / procedural improvements, providing input to management and taking the initiative, as appropriate.\nRecognize, exemplify and adhere to Parexel values and standards\nReview Parexel SOPs as assigned to ensure GxP compliance of processes\nMaintain compliance with training curriculum.\n\nBuild and maintain relationships\n\nBuild, develop, and maintain good working relationships with internal and external customer groups\nWork well in a team environment.\nLiaise with clients and operational staff on quality aspects which may include attendance of meetings, presentations and audits\n\nSkills\n\nPerform other quality related task or initiatives as assigned\n\nAbility to rapidly learn, understand and apply applicable Parexel and client procedures\nAbility to work flexible and across multicultural environment\nAbility to learn and use Parexel and client computer systems\nClient focused approach to work\nAbility to develop good working relationships with a culturally diverse group of Parexel and client personnel\nWillingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork\nExcellent interpersonal, verbal, and written communication skills, including the ability to present at conferences, meetings and training sessions\nAbility to mentor / train auditors and other personnel\nExcellent organizational, analytical, problem solving, decision making and negotiation skills\nEffective at analyzing problems considering the big picture and recommending appropriate corrective actions\nAbility to work independently and consistently in a fast-paced environment.\nAccurate and detail oriented, a critical thinker\nExcellent time management skills with the ability to prioritize workload and manage multiple and varied tasks / projects with enthusiasm\nA flexible attitude to work assignments and new learning and the ability to adjust to changing priorities and unforeseen events\nAbility to diplomatically address sensitive issues confidentially and professionally\nAbility to work professionally with highly confidential information\nTeam leadership abilities and positive attitude. Experience with using computer systems and software, including Microsoft Office\nAuditors must be detail oriented, good at decision making, able to maintain a big picture / overview on the project / business\nAbility to follow up on multiple tasks and projects, and to handle confidential information diplomatically.\n\nKnowledge And Experience\n\nMinimum of 4 years experience in quality assurance, auditing, including sound experience of applicable GxP auditing\nAt least 7 years experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier management\nExcellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research\n\nEducation\n\nEducated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience\nMaster's degree in a science, technology or industry related discipline, preferred.","description_format":"text","description_chars":8718,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)"],"lifecycle":[{"event":"open","at":"2026-09-25T13:06:44Z"},{"event":"open","at":"2026-10-12T05:15:34Z"}],"visa":[{"country":"GB","licensed_sponsor":true,"evidence":"Licensed UK visa sponsor (Senior or Specialist Worker, Skilled Worker)","filings_12m":null,"filings_prev_12m":null,"green_card_filings_12m":null,"median_offered_wage_usd":null,"route":"Global Business Mobility: Senior or Specialist Worker; 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Docs: https://alion.io/developers"}}