Senior Project Manager – Sterile GMP Line Expansion (Plasma Manufacturing)
Location and working setup
Brussels, Belgium
Full-time, on-site
Permanent position
Competitive base salary plus bonus and benefits
BioTalent are partnered with a global pharmaceutical manufacturer with an established European footprint in biologics and specialty medicines. One of their key manufacturing sites is entering a major expansion phase within its plasma-derived products division. Demand is rising, capacity needs to scale, and this is a significant on-site investment in new sterile GMP production lines.
They are now hiring a Senior Project Manager – Sterile GMP Line Expansion to lead delivery of this expansion programme in Belgium.
The impact
You will be responsible for ensuring that two new sterile plasma production lines are built, installed, qualified and ready for inspection and commercial supply. If delivered well, the site increases capacity and strengthens its position within the group. If delayed or mismanaged, it directly affects supply continuity and revenue. You will sit close to site leadership and carry genuine accountability for timelines, risk and execution.
Key responsibilities
• Lead day-to-day delivery of sterile GMP line expansion projects
• Own project plans, governance, budget tracking and risk management
• Coordinate Engineering, Validation, QA, Regulatory and Operations teams
• Oversee equipment installation and qualification including IQ/OQ/PQ
• Ensure full alignment with EU GMP and Annex 1 requirements
• Manage external vendors and contractors
• Provide structured reporting to senior site leadership
• Drive inspection readiness and transition into operational handover
You are not expected to operate equipment or write validation protocols line by line. You are expected to make sure they are delivered properly, on time and in line with compliance standards.
Who this role suits
This is suited to a Project Manager who has delivered within sterile GMP manufacturing before. Ideally you will have experience in plasma, fractionation or sterile biologics environments.
You will likely have:
• Experience leading CAPEX-driven manufacturing line builds or expansions
• Strong understanding of EU GMP and Annex 1
• Exposure to validation oversight including IQ/OQ/PQ
• Confidence managing cross-functional technical teams
• The credibility to challenge delays and drive resolution
This is not for junior PMs without sterile exposure. It is also not a consultancy oversight position. It requires on-site leadership and hands-on programme ownership.
For someone who wants to move from incremental project work into meaningful expansion delivery, this offers scale, visibility and accountability within a well-backed global organisation.
If you have delivered sterile GMP manufacturing expansion projects and want something with real technical and commercial impact, I would welcome a confidential conversation.