Senior Project Manager

i-Pharm GxP; Illinois; On-site; USD 140,000 - 170,000; Full time

Job summary

i-Pharm GxP is seeking a Senior Project Manager to lead site sterility assurance initiatives for EU Annex 1 compliance across facilities and systems. The role focuses on design management, qualification and project execution through 2028.

The successful candidate will oversee cross-functional teams, coordinate with SMEs, A&E partners, and Construction Management, and ensure deliverables align with client requirements and regulatory standards.

Qualifications

• 10+ years of site sterility/GxP project management experience.
• Proven ability to lead design management and qualification activities.

Responsibilities

• Lead assigned project design management activities and design reviews.
• Collaborate with client SMEs, A&E partners and Construction Management groups.
• Generate GxP Assessments and Project Execution Plans.
• Oversee development of User Requirement Briefs and project master schedules.
• Maintain and update document trackers and status reports.
• Manage day-to-day resources within assigned workstreams and ensure on-time delivery.

Skills

Design management

Qualification

Job description

A major pharmaceutical manufacturer has initiated a Site Sterility Assurance Program to comply with EU Annex 1 requirements across its facilities and systems.

The program is intended to design and deliver qualified and validated existing pharmaceutical manufacturing facilities and processes by fiscal year 2028. The scope includes transitional spaces, changing rooms, HVAC improvements, process improvements including Single Bag Use, PUPSIT and CCIT, environmental controls, and other related remediation activities.

Position

The client requires one Senior Project Manager with considerable experience in:

• Design management and review
• Qualification

The Senior Project Manager will lead execution activities associated with the defined project scopes and will report to the Project Engineering Program Director.

Project Scopes

The Senior Project Manager will manage the team associated with the following project scopes:

• CCIT Install & Qualification
• B16N Compliance and Improvement
• B16N Aseptic Installation of Needles
• B16 Grade C Pass-Through Improvement
• B16N Compliance and Improvement
• PUPSIT Compliant Sterile Filtration
• CNC Halls and Change Rooms
• Dispensing and Sampling Environment Upgrade
• B16N Washroom Expansion
• Site Execution

Key Responsibilities

• Lead assigned project design management activities and design reviews.
• Collaborate with client SMEs, A&E partners and Construction Management groups.
• Lead and/or participate in the generation of:
• GxP Assessments
• Project Execution Plans
• User Requirement Briefs
• Oversee Project Engineering activities in accordance with the client’s project delivery requirements for Tier 2 and Tier 3 projects.
• Oversee the generation, review and approval of documentation related to the project master schedule.
• Maintain and update document trackers.
• Manage day-to-day activities of resources within assigned workstreams.
• Ensure deliverables are completed on time and in compliance with standards.
• Manage and communicate deliverables, risks and requirements with project teams and stakeholders.
• Ensure Project Engineering, C&Q and CSV deliverables are met.
• Manage additional deliverables as required by the client.

Experience Requirements

• 10+ years of experience

Demonstrated experience in:

• Design management and review
• Qualification

Project Schedule

• Start: October 2026
• End: December 2028
• Coverage: Project Planning, Detail Design through Project Completion