Project Manager

• 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.
• PMP certification or equivalent is a strong asset.

• 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.

Fluent in Spanish and English are mandatory for this position.

• Fluent in Spanish and English (native or high professional level required).

Position Title: PROJECT MANAGER

Location: Madrid

The Project Manager is responsible for leading cross-functional projects related to sterile injectable drug products. The role ensures timely delivery of milestones in compliance with GMP, global regulatory standards, and internal quality systems, with a strong focus on Quality Assurance, CAPA governance, and team leadership.

The PM will act as a key point of coordination and monitoring, ensuring the efficient execution and fulfillment of the strategic objectives of technical transfer projects.

• Lead end-to-end project execution for injectable drug products, aseptic manufacturing processing, fill-finish operations and packaging.
• Ensure, together with the Business Unit Head (BUH), that the necessary capacity exists to meet project milestones.
• Assess potential time or capacity constraints in advance to identify and implement mitigation plans in a timely manner.
• Coordinate post-technical transfer activities, ensuring the successful launch of the product.
• Coordinate cross-functional teams (R&D, QA, QC, Regulatory Affairs, Engineering, Manufacturing, Supply Chain) to meet project milestones.
• Develop and manage detailed project plans, timelines, budgets, and risk mitigation strategies.
• Ensure compliance with global regulatory requirements (FDA, EMA, WHO) and GMP standards for sterile products.
• Oversee technology transfer activities between development sites and commercial manufacturing facilities.
• Support validation activities (equipment, process, cleaning) and readiness for regulatory inspections.
• Lead and track Change Control processes related to equipment, documentation, and process modifications.
• Manage and resolve CAPAs in collaboration with QA and operational teams, ensuring timely closure and effectiveness verification.
• Provide leadership and guidance to project team members, fostering collaboration, accountability, and performance.
• Facilitate project meetings, generate progress reports, and communicate updates to senior leadership.

Type of Contract: Full-Time

This position may require travel lasting two to three months.