Regional C&Q Support

Our Client is a leading global biopharmaceutical organisation committed to developing innovative medicines that improve patient outcomes and address critical healthcare needs.

This role is outsourced to our Client. The Regional Commissioning and Qualification (C&Q) Support reports to the C&Q Lead and is focused on engaging the packaged equipment/system suppliers and facilitating with project C&Q deliverables for the Client's Manufacturing Facility.

1. On-site presence: Located primarily at main supplier factory location during design, fabrication, FAT, and pre-shipment phases; required to travel and be embedded with other vendors/suppliers during critical execution and preparation, as applicable.

1. Quality by Design (QbD) and C&Q lifecycle alignment and coordination: Close liaison with packaged equipment/system suppliers to align on C&Q test approach and deliverables derived from Validation Master Plan (VMP) and C&Q Execution Plan (CQEP) to agreed scope, schedule, quality, and safety.

1. Stakeholder and interface management: Serve as regional representative and focal point between suppliers and AZ stakeholders including C&Q Program Manager, C&Q Lead, Quality Lead, Subject Matter Experts (SMEs) and/or System Owners to align on C&Q requirements.

1. Suppliers’ management: Manage deliverables such as Vendor Turnover Packages (VTOPs), Construction Turnover Packages (CTOPs), suppliers’ Inspection Test Plan (ITP), Factory Acceptance Testing (FAT) protocols and Site Acceptance Testing (SAT) protocols, where applicable, as part of C&Q documentation lifecycle delivery.
2. Ensure completeness and quality of Vendor Turnover Packages (VTOPs) to enable smooth transition into site C&Q (CTOP, SAT, IQ/OQ).
3. Readiness management - Drive vendor readiness for Design Qualification (DQ), Pre-FAT, and FAT by ensuring documentation, test protocols, and systems are aligned and approved ahead of execution.

1. Compliance:
2. Ensure deliverables comply with regulatory, quality and SHE standards.
3. implement global standards and procedures and maintain audit-ready documentation. Define and enforce compliance for the scope area.
4. Set metrics and intervene to correct performance as needed, especially related to non-compliance, quality risk, or deviation from approved requirements.
5. Key understanding of the design and relevant aspects to C&Q – able to notify and flag where construction is making changes against approved design without client approval / notification.
6. Perform technical reviews of supplier design documentation (e.g. P&IDs, specifications, control strategies) to ensure compliance with URS and GMP requirements, as applicable (RTM/DQ).
7. Ensuring all documentation generation and data entries follow Good Documentation Practices (GDP).

1. Controls and reporting:
2. Establish integrated controls for risks, changes, issues, and progress.
3. Provide transparent reporting against performance baselines and the master plan, escalating and driving recovery actions when required.
4. Provide continued oversight (QbD) of fabrication, documentation, and construction testing activities real progress.
5. Provide visibility on constraints, and risks (e.g. fabrication limitations, local practices, workshop constraints) that may impact project delivery.

1. Schedule accountability:
2. Own scope schedules.
3. Track commitments, forecasts, and variances.
4. Manage schedule performance to deliver within approved parameters.

1. Degree or Diploma in Engineering, Life Sciences, or a related discipline.
2. Relevant experience in Commissioning & Qualification (C&Q) within pharmaceutical, biotechnology, or GMP-regulated manufacturing environments.
3. Experience coordinating with equipment suppliers and managing C&Q deliverables throughout design, fabrication, testing, and handover.
4. Familiarity with C&Q documentation, including URS, RTM, DQ, FAT, SAT, and Vendor Turnover Packages (VTOP).
5. Good understanding of GMP, Good Documentation Practices (GDP), quality standards, and SHE requirements.
6. Experience reviewing technical documentation, including P&IDs, equipment specifications, and testing protocols.
7. Strong stakeholder management and communication skills, with the ability to coordinate across suppliers, project teams, Quality, and C&Q stakeholders.
8. Ability to manage project schedules, track deliverables, identify risks, and resolve issues to meet project milestones.
9. Willingness to work on-site at supplier factories and travel regionally as required.
10. Strong organisational, problem-solving, and reporting skills.

Be part of the pioneer team in Singapore and play a unique role in building and shaping the organisation’s operations from the ground up. As one of the first team members, you’ll have greater visibility and influence, the opportunity to shape processes and ways of working, and the chance to take on broader responsibilities as the organisation grows. You’ll also gain valuable exposure to senior stakeholders, build strong cross-functional relationships and establish a career foundation within a growing global organisation. It’s an opportunity to be there from the beginning, make your mark and grow alongside the business.