Global Commissioning & Qualification Lead

CSL

About The Position

The C&Q Lead is responsible for developing and executing the global commissioning and qualification strategy for Tier 1 capital projects across the biopharmaceutical network. This role ensures compliance with regulatory standards (FDA, EMA, ASTM E2500), drives harmonization of C&Q practices, and provides technical leadership to site engineering teams. A critical focus of this position is to define, implement, and sustain a strategic shift in the operating model—from a hybrid of self-perform and partner execution to a highly partnered model for C&Q execution across both at-site and above-site projects. The C&Q Lead will champion this transformation, ensuring robust partnership governance, capability building, and seamless integration of external partners into the global C&Q delivery framework. The position also includes establishing strategic partnerships with external C&Q execution vendors and ensuring readiness for regulatory inspections.

Requirements

Bachelor’s or Master’s degree in Engineering (Mechanical, Chemical, Process) or related discipline.
12+ years in GMP-regulated pharmaceutical manufacturing with strong C&Q expertise.
Minimum 8 years in leadership roles managing global or multi-site C&Q programs.
PMP or equivalent; ISPE C&Q training preferred.
Deep knowledge of ASTM E2500, ISPE Baseline Guides, and risk-based C&Q methodologies.
Familiarity with validation master plans and computerized systems compliance.

Nice To Haves

Experience with biologics, cell & gene therapy, or sterile manufacturing facilities.
Familiarity with digital C&Q platforms and data analytics tools.
Global mindset and ability to work in a matrix organization.

Responsibilities

Develop and implement change management strategies to support the adoption and sustainability of the new operating model across the organization.
Establish and manage robust commercial partnerships with C&Q execution firms, including defining partnership frameworks, performance metrics, and continuous improvement mechanisms.
Drive the transition from a hybrid self-perform/partner model to a highly partnered C&Q execution model, ensuring external partners are fully integrated into project delivery at both site and global levels.
Define and implement global C&Q standards aligned with ASTM E2500 and ISPE guidelines. Develop governance structures to ensure consistent application across all sites.
Lead C&Q scope for major capital projects ($50M+) including utilities, facilities, and process equipment. Ensure timely delivery of C&Q deliverables (DQ, FAT, SAT, IQ, OQ, PQ) within project timelines and budgets.
Establish and manage commercial partnerships with C&Q execution firms. Negotiate contracts and ensure vendor compliance with global standards.
Provide expert guidance to site engineering teams on C&Q execution and troubleshooting. Build technical capabilities and mentor site CQ SMEs to ensure knowledge retention.
Ensure C&Q programs meet global regulatory requirements and support audit readiness. Lead responses to regulatory inspections related to commissioning and qualification.
Benchmark industry best practices and implement digital tools for C&Q lifecycle management. Drive risk-based approaches and automation in C&Q processes.