Save Job Back to Search Job Description Summary Similar JobsHigh-Impact Leadership in End-to-End Biopharma OperationsGlobal Visibility Through Regulatory & Strategic EngagementAbout Our ClientOur client is a rapidly growing biopharmaceutical organization focused on developing and manufacturing biosimilars, biologics, and specialty medicines with global regulatory approvals. They operate advanced facilities in India and the USA, driving innovation in sterile injectables, formulations, and cutting-edge drug delivery systems.Job DescriptionThe key responsibilities include:Technical LeadershipProvide strategic direction for all technical operations, including biologics manufacturing, sterile injectables, formulation, and fill-finish activities.Ensure strict adherence to cGMP, GDP, and data integrity standards.Oversee technology transfer, process optimization, and scale-up from R&D to commercial production.Lead investigations into deviations, OOS, and OOT issues while driving CAPA initiatives.Collaborate with Quality, Engineering, and Supply Chain to meet production and quality goals.Ensure equipment qualification, validation, and preventive maintenance schedules are effectively implemented.Site AdministrationOversee all site administrative functions, including facilities management, canteen, security, transport, housekeeping, and guest services.Ensure robust infrastructure support (utilities, WFI, HVAC, ETP/STP, civil, and electrical systems).Manage site budgets, vendor contracts, and cost-control measures for admin services.Coordinate with HR for workforce planning, labor contractor management, and employee welfare initiatives.Compliance & Regulatory LiaisonLead readiness for all regulatory audits (USFDA, MHRA, WHO, EMA, etc.) and customer inspections.Ensure all licenses, permits, and statutory requirements under Factories Act, PCB, and local authorities are up to date.Act as the primary liaison with government agencies, industrial associations, and local governing bodies.EHS & Risk ManagementImplement and monitor all Environment, Health, and Safety (EHS) programs at the site.Ensure fire safety, hazard control, and emergency response systems are in place and regularly tested.Promote sustainability, waste management, and green initiatives at the site.People LeadershipProvide direction to cross-functional teams (Production, Quality, Engineering, Warehouse, EHS, and Admin).Drive a performance-driven culture and ensure skill development, leadership pipeline building, and employee engagement.Foster transparent communication between site teams and corporate leadership.The Successful ApplicantA successful Site Head should have:Education:B.Tech / M.Tech (Biotechnology / Chemical Engineering) or B.Pharm / M.Pharm.Additional qualifications in industrial administration or management are a plus.Experience:20+ years of experience in BioPharma / sterile manufacturing with at least 5-7 years as a Plant Head for biosimilars.Proven track record of managing both technical operations and plant administration in a regulated environment.Hands-on experience in facing global regulatory audits (USFDA, EMA, WHO, etc.).Key Competencies:Strong technical depth in biosimilars, biologics, injectables, or sterile manufacturing.Proven administrative and infrastructure management capabilities.Excellent regulatory knowledge and statutory compliance understanding.Strong leadership, decision-making, and cross-functional collaboration skills.Vendor and budget management expertise.Crisis management and stakeholder engagement.What's on OfferThis leadership role offers the opportunity to take full ownership of a state-of-the-art biopharmaceutical manufacturing site, combining technical depth in biosimilars with administrative authority over infrastructure, compliance, and workforce welfare.Quote job refJN-012026-6915242Job summaryFunctionHealthcare & Life SciencesSub SectorManufacturing / QualityWhat is your area of specialisation?Healthcare / PharmaceuticalLocationAhmedabadJob TypePermanentJob ReferenceJN-012026-6915242