GM – Manufacturing CoE Aseptic & Sterile

Position: GM – Manufacturing CoE - (Aseptic & Sterile)
General Manager – Manufacturing Centre of Excellence (Aseptic & Sterile)

Location:

Nagpur, India

Stanley Cowton International has been retained by a global pharmaceutical manufacturer to appoint a senior leader to build and lead a Manufacturing Centre of Excellence focused on aseptic and sterile operations.

This is a newly created, high-impact role for a recognised sterile expert who wants to shape strategy, influence multiple facilities, and raise standards to best-in-class across complex injectable manufacturing.

The Opportunity

This position sits above day-to-day production and carries a clear mandate to define, implement, and sustain world-class aseptic practices. You will act as the sterile authority for the organisation, partnering closely with site leadership, quality, microbiology, and engineering teams.

The business is well invested in modern sterile technology, including advanced filling lines, isolators, and automation. The focus now is on deepening sterile expertise, strengthening sterility assurance, and embedding a consistent aseptic culture across sites.

The role offers strong visibility, autonomy, and long-term scope as the organisation expands further into complex injectables and, over time, biotech manufacturing.

Key Responsibilities

- Establish and lead a Manufacturing CoE for aseptic and sterile operations
- Own and drive sterility assurance strategy, including CCS, EM programmes, media fills, and contamination control
- Lead EU GMP Annex 1 implementation and ensure inspection readiness for global regulators
- Act as subject matter expert during regulatory inspections and internal audits
- Standardise aseptic practices across lines, shifts, and sites
- Lead sterile investigations, root cause analysis, and CAPA effectiveness
- Build, coach, and develop sterile capability through structured training and knowledge transfer
- Influence senior stakeholders in a multi-site, matrix environment

Requirements

- Extensive experience in sterile and aseptic pharmaceutical manufacturing, ideally within injectables
- Deep, practical expertise in EU GMP Annex 1 with exposure to US FDA inspections
- Proven ownership of sterility assurance and contamination control programmes
- Background in microbiology, quality, engineering, or sterile operations
- Experience operating across multiple sites or within a Centre of Excellence model
- Strong change leadership, communication, and influencing skills
- Willingness to be based in Nagpur and travel regularly between manufacturing sites

Why Consider This Role

- Rare opportunity to build a sterile Centre of Excellence from the ground up
- Strategic, retained search with direct access to senior leadership
- Strong technology platform with ambition to reach best-in-class sterile standards
- Clear long-term career progression as the organisation expands in complexity and scale

All applications and discussions will be handled in strict confidence.