Position Title: PROJECT MANAGER
Location: Madrid
Type of Contract: Full-Time
Position Summary
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.
This position may require travel lasting two to three months.
Fluent in Spanish and English are mandatory for this position.
Key Responsibilities
- 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.
Qualifications
- 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.
- Fluent in Spanish and English (native or high professional level required).
Preferred Experience
- 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.
What We Offer
- Competitive compensation and benefits
- Opportunity to lead high-impact injectable drug programs
- Collaborative and innovation-driven work environment
- Professional development and career growth
Join us: If you are a dedicated and highly motivated individual with a passion for ensuring the highest standards of Engineering and Quality in the Pharmaceutical Industry, we encourage you to apply. PharmEng / Efor offers a dynamic and inclusive work environment, competitive compensation, and opportunities for professional growth. Be part of our team and contribute to the success of our industry-leading solutions.
PharmEng / Efor is an equal opportunity employer and welcomes applicants from all backgrounds.
Thank you for your consideration and application! We review all resumes and submissions, however, due to the high volume of applications we receive, only approved candidates will be contacted.
