Project Manager
On-siteMadrid, Madrid, Spain
Job Summary
Lead end-to-end project execution for sterile injectable drug products, managing technical transfers, change controls, and CAPA governance in compliance with GMP and global regulatory standards. Coordinate cross-functional teams across R&D, QA, Manufacturing, and Supply Chain to ensure timely milestone delivery, while developing detailed project plans, budgets, and risk mitigation strategies. Assess capacity constraints with the Business Unit Head to prevent delays and oversee technology transfer activities between development and commercial sites. Fluent in Spanish and English are mandatory. Full-time role in Madrid with potential travel of two to three months.
Required Qualifications
- Fluent in Spanish and English
- Bachelors or masters degree in Pharmacy, Chemistry, Biotechnology, Engineering, or related field
- Minimum 5 years of experience in project management within sterile pharmaceutical manufacturing
- Strong understanding of aseptic processing, terminal sterilization, and cleanroom operations
- Proven track record managing injectable products, tech transfer, and QA-related activities
- Hands-on experience with CAPA systems, Change Control management, and quality documentation workflows
- Demonstrated leadership experience managing cross-functional teams
- Proficiency in project management tools
- Fluent in Spanish and English (native or high professional level required)
Desired Qualifications
- PMP certification or equivalent
- Experience with high-potency APIs, biologics, or complex injectable formulations
- Familiarity with Annex 1 (EU GMP) and 21 CFR Part 211 compliance
- Knowledge of regulatory submission processes (IND, NDA, MAA)
- Exposure to Lean, Six Sigma, or Agile methodologies
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