Senior Project Manager – cGMP
Location: Remote with international travel (up to 20%)
Company: Bridge Business Support Services
Employment Type: Full-time or contract (Manager)
About the Role
Bridge Business Support Services is leading the implementation of a fully automated, FDA-cGMP-compliant artemisinin production line, scheduled for completion by mid-2026. We are seeking a Senior Project Manager to direct this initiative from detailed engineering through commissioning. This position is responsible for maintaining project scope, schedule, cost, risk management, and vendor coordination, ensuring that all milestones are met within regulatory and quality frameworks.
Core Responsibilities
Project Execution & Control
- Develop and manage a Level-3 schedule using Primavera P6 or MS Project
- Implement cost baselines, earned-value metrics, and a comprehensive WBS
- Oversee weekly technical meetings and monthly governance reviews
Vendor and Contract Oversight
- Lead procurement processes, including RFIs and bid evaluations
- Negotiate and manage fixed-price contracts and commercial risks
- Validate payment milestones and track contract performance
Technical Integration Management
- Coordinate multidisciplinary teams across process, automation, and CQV
- Organize formal reviews such as HAZOPs, model walkthroughs, and FATs/SATs
- Ensure alignment of PFDs and P&IDs across stakeholders
Regulatory Compliance and Quality
- Ensure alignment with FDA cGMP guidelines and 21 CFR Part 11
- Support CQV documentation including IQ/OQ/PQ protocols and validation records
Reporting and Communication
- Generate dashboards covering schedule, costs, risks, and corrective actions
- Prepare audit-ready documentation and compliance reports for grant oversight
Leadership and Culture
- Mentor junior staff and enforce a strong project safety culture
- Promote transparency, accountability, and adherence to internal procedures
Required Qualifications
- Degree in Chemical, Mechanical, Industrial Engineering, or related discipline
- PMP, PRINCE2, or equivalent project management certification
- Minimum 10 years managing capital projects in regulated industries
- Proven success delivering production facilities with batch or hybrid processing
- Expertise in Primavera P6, MS Project, and Excel for scheduling and budgeting
- Strong vendor management and contract negotiation experience
- Fluency in written and spoken English
- Experience leading geographically dispersed teams
Preferred Qualifications
- Lean Six Sigma certification or training
- Experience with PAT, PLC/DCS, and 21 CFR Part 11 systems
- Knowledge of green chemistry or solvent recovery
- Familiarity with ISO 9001, OSHA PSM, or comparable standards
Compensation and Benefits
- Competitive compensation structure (salary or day rate, USD-based)
- Flexible, remote-first work environment
- Access to modern collaboration platforms (MS Teams, SharePoint, Odoo)
- International travel opportunities
- Direct involvement in mission-critical pharmaceutical development
- A culture of continuous improvement and measurable impact
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