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Job Description

  • High-Impact Leadership in End-to-End Biopharma Operations
  • Global Visibility Through Regulatory & Strategic Engagement

Job Description

The key responsibilities include:

  1. Technical Leadership
  • Provide 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.
  1. Site Administration
  • Oversee 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.
  1. Compliance & Regulatory Liaison
  • Lead 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.
  1. EHS & Risk Management
  • Implement 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.
  1. People Leadership
  • Provide 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 Applicant

A 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 Offer

This 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.

More Info

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About Company

Michael Page has five decades of expertise in professional services recruitment. We were established in London in 1976, and over this period we've grown organically to become one of the best-known and most respected consultancies, with an office network spanning six continents.
While size has its advantages, it doesn't define us - the nature of our organic growth means that each new office is integrated into the region that it serves. It also means that as an employer looking to hire, or as a candidate aiming to grow your career you have the best of both worlds&#x3B; a team that understands the market and geography you operate in, plus the resources and expertise of an international network at your disposal.

Job ID: 138415437