Pharma New Product Introduction Project Lead

ROIS; San Sebastián de los Reyes; On-site; EUR 60,000 - 85,000; Full time

Job summary

ROIS is seeking a New Products Introduction Project Manager to plan and coordinate technology transfer and product variation projects in a pharmaceutical manufacturing environment. You will ensure timely delivery, budget control, and regulatory compliance while facilitating collaboration between clients and internal departments.

The role requires organizing project plans, coordinating cross-functional teams, and managing documentation such as CC, URS, QA, AMT, PVP, and stability workstreams.

Qualifications

• Experience in technology transfer and project management within the pharmaceutical industry.
• Familiarity with regulatory documentation and compliance standards.
• Strong organizational, communication, and problem-solving skills.
• Ability to coordinate and manage cross-functional teams effectively.

Responsibilities

• Develop the Technology Transfer Plan and/or Change Control documentation, including project budgets, timelines, and team structures.
• Draft and circulate plans for review, feedback, and approval.
• Create and maintain a comprehensive project schedule with activities, responsibilities, and deadlines.
• Manage project execution to meet established goals for deliverables, timelines, and budgets.
• Identify project stakeholders and ensure effective communication of client requirements to the manufacturing plant.
• Schedule and coordinate necessary meetings, teleconferences, and updates.
• Act as a liaison between departments and clients, fostering collaboration and resolving issues.
• Coordinate and contribute to the preparation of key documents, including: Change Controls (CC), User Requirement Specifications (URS), Quality Agreements (QA), Analytical Transfer Protocols (AMT), Process and Cleaning Validation Protocols (PVP), Stability Plans, Specifications, and Artworks.
• Ensure all project documentation meets regulatory and company standards.
• Track project progress, identify potential risks, and implement solutions to mitigate delays or issues.
• Support investigations and problem-solving throughout the project.
• Manage project budgets and expenses, providing updates as needed.
• Finalize all required documentation and reports for project completion (e.g., TTP Report).
• Communicate the completion of billable activities to relevant stakeholders.
• Provide support and expertise for other projects when needed.

Job description

ROIS is seeking a New Products Introduction Project Manager to plan and coordinate technology transfer and product variation projects in a pharmaceutical manufacturing environment. You will ensure timely delivery, budget control, and regulatory compliance while facilitating collaboration between clients and internal departments.

The role requires organizing project plans, coordinating cross-functional teams, and managing documentation such as CC, URS, QA, AMT, PVP, and stability workstreams.