Senior Project Manager - Pharma sector
Posted Updated 6
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Summary
Leads planning, execution, and compliance for commissioning, qualification, and validation projects in a new greenfield ADC biopharma manufacturing facility in Singapore, ensuring adherence to cGMP, GAMP 5, and ALCOA+ standards.
You’ll be responsible for:
- Project Leadership & Delivery: Leading the technical, operational and documentation scope for the C&Q and CSV workstreams supporting a major new greenfield ADC manufacturing facility in Singapore.
- Client & Stakeholder Governance: Acting as the primary point of contact for the client's engineering, CQV and QA leads; managing timelines, deliverables routing, resource allocation and project controls.
- CQV/CSV Oversight: Driving the preparation, digitization and tracking of C&Q/CSV documentation across Drug Substance, Drug Product, QC Labs, Utilities, and Warehouse systems.
- Compliance & Standards Alignment: Ensuring all project methodologies and team outputs strictly adhere to GAMP 5, cGMP and Data Integrity (ALCOA+) principles.
- Risk & Quality Management: Overseeing System Risk Assessments, Design Qualifications, Requirements Traceability (RTM), and Qualification Summary Reports.
About you:
- Experience: 12 to 15+ years of proven project management experience leading C&Q/CSV packages for large-scale pharmaceutical or biotech projects.
- Technical Background: Deep domain knowledge in Commissioning, Qualification, and Validation (CQV), Computer System Validation (CSV) and industrial automation within regulated facilities (preferably ADC, Biologics, or Fill-Finish).
- Education & Certifications: Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related technical discipline. PMP, Prince2, or ISPE/GAMP certifications are highly preferred.
- Leadership & Strategy: Demonstrated ability to manage multi-disciplinary engineering/validation teams, navigate complex client environments and maintain strict quality control against tight delivery timelines.