{"id":1222616,"url":"https://alion.io/job/sun-pharma-qc-training-manager","title":"QC & Training Manager","company":{"id":1808960,"name":"Sun Pharma","domain":"sunpharma.com","url":"https://alion.io/company/sun-pharma","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"HR","role_family":"HR","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Mumbai, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":24000,"max_usd":54000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":1521},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false}],"status":"live","first_seen_at":"2026-09-25T12:42:34Z","employer_posted_date":"2026-09-25","last_verified_at":"2026-09-26T12:41:17Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Job Title:\n\nQC & Training Manager\n\nBusiness Unit:\n\nMACR\n\nGrade:\n\nG10\n\nLocation:\n\nMumbai\n\nYOUR TASKS AND RESPONSIBILITIES:\nThis role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical Trial Supply Management (CTSM) team, and Clinical Data Management team by way of Review of all study related activities, processes, procedures and adherence to applicable regulations and guidelines to ensure 24x7 Inspection/audit readiness.\nThis role will be responsible for establishing the procedures and trainings of teams which ensure protection of human subjects from research risk, reliability/Integrity of the data, and thereby assures internal consistency and Quality Compliance measures.\nSystems and Processes:\nDevelop, implement and maintain a Quality Management System (QMS) for clinical trial team in consultation with Head - Quality Compliance & Training and ensure oversight on team on quality aspect as per defined SOPs and applicable regulations.\nImplement and oversee the Quality Compliance procedures/processes/systems for clinical trials managed by the Medical science and Clinical Operations department.\nTo assist in designing a process to write, review and approve the risk assessments for new trials and for ongoing projects and working closely with Project Managers and Operation Head as needed. \nTo ensure a process in place to provide assurance on review of all study documentation for accuracy, consistency and completeness.\nEnsure effective systems and processes in place to maintain consistency and quality compliance parameters in medical science, operations, data management and drug depot for end-to-end activities of each function as per applicable regulatory requirements. \nWork with Clinical Research QC team, Medical Science team, Clinical Operations team, Clinical Data Management team and Study Management team to create and implement study specific QC plans that outline the scope of Quality Compliance procedures to be followed during clinical trials, ensuring QC processes are in alignment with SOPs and study protocols.\nEnsure completeness of training of study team on SOPs and job specific training as per role and responsibilities. Ensure periodic review of training files for all study team.\nAssess and identify the training requirement of study team and ensure completion of training.\nWell versed with electronic systems used in Clinical Trial operations, Data Management and Project Management which includes project specific deliverables tracking and important milestone related alarms, protocol compliance tracking, deviations tracking and electronic systems used for managing Trial Master File (TMF) and Drug accountability.\nAssist in developing system/process to work with the clinical trial team to schedule pre-execution and post-execution QC activities to ensure that all requirements of the QC plans are planned as required and executed.\nPlan, design, and update process and systems for clinical trial activities like development and utilization of QC assessment parameters and other QC tools designed to document/track the QC review process for clinical research activities in line with recent regulatory requirement.\nEnsure Quality Management System at Medical Science, Data Management team, Operation team to ensure the department is ready for audit/inspection 24x7.\nEnsure periodic review of Vendors and renewals as per applicable policies & procedures.\nIdentify and recommend process improvement initiatives where required.\nCreate and evaluate metrics to assess performance and implement plans for course correction. \nActivities:\nShould be effective team player who can work closely with different study teams and collaborate well with team members to achieve defined QC targets.\nDevelop and implement a risk-based and flexible approach to Quality Compliance (QC) within the function, which will ensure that trial participants and data are safeguarded in compliance with applicable regulatory requirements and best practices.\nIdentify and decide team member’s job specific SOP training requirements in view of their role and maintain oversight of training to ensure all team members are trained on each SOP as required.\nPreparation of SOPs related to QC function and support in review of SOPs specific to Medical science, Clinical team and Data Management team.\nQuality review of the clinical trial medical science related activities like Synopsis, Protocol, Clinical Study Report (CSR) and appendices, and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement. \nQuality review of the clinical trial operation related activities, related tools, plans and documentation like site feasibility, site selection visit, site initiation, Ethic committee documentation, monitoring - site specific reports, Site Documents, logs and close out activities in line with ICH GCP requirement, Indian and global regulatory requirement.\nEnsure Quality review of SOPs and oversight on quality parameters specific to Clinical Trial Supply Management (CTSM) and other activities like receipt, handling of study sample, labelling, storage, temperature monitoring systems and distribution to trial sites.\nFinal QC review of study close out activities including returned goods reconciliation, inventory destruction processing and archiving of documents. \nReview and communication of QC findings to respective department in stipulated timelines.\nArrange monthly meeting or meetings as and when required depending on criticality of the issues with concerned team to discuss and communicate the findings from QC reviews to the internal stakeholders via QC summaries, reports as required.\nMaintain the repository of QC findings as per the department and specific function and present the trend analysis, training requirement and action plan with timelines to Head - Medical Affairs and clinical for course correction on quarterly basis.\nEnsure training of SOPs, on job training and reviewing training files on regular basis.\nQC review and Support in preparation of clinical study manuals/documents/Plan such as the IMP handling manual, Study plans.\nEnsure record maintenance for all activities for traceability in line with regulatory requirement.\n\nJob Requirements\n\nEducational Qualification\n\nBachelor's or Masters degree in a health or related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research\n\nExperience\n\nRelevant experience of 5 years in the field of Clinical Research.\n\nAdditional Skills:\n>5 years’ experience in a CRO/Pharma/Biotech organization in Quality department with experience of Quality activities in Clinical Research department.\nStrong eye for detail and ability to spot inconsistencies a must and good conflict management skills.\nMust have experience in handling audits & inspections of DCGI, US FDA.\nThorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations and other applicable regulations pertaining to clinical trials.\nExperience of working in matrix business environments preferred.\n\nYour Success Matters to Us\nAt Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!\n\nDisclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).","description_format":"text","description_chars":8111,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Generic Drugs","OTC & Consumer Health Products","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-09-25T12:42:34Z"}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":31,"reasons":["conf:2","win:early","comp:brand"],"computed_at":"2026-09-26T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/sun-pharma-qc-training-manager","json_url":"https://alion.io/job/sun-pharma-qc-training-manager.json","meta":{"generated_at":"2026-09-27T01:29:54Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":1351,"day_limit":5000,"remaining_today":3649,"minute_limit":60,"resets_at":"2026-09-28T00:00:00Z"}}}