Principal Commissioning and Qualification Manager

Please note there are three roles available; they can be based in either Hillsboro OR or Holly Springs NC

This role is a vital part of Roche's Global Engineering team, which partners with Pharma Technical Operations (PT) and other divisions to deliver world-class capital projects that enable our global manufacturing operations. As a Commissioning & Qualification Manager, you will lead complex, cross-functional teams through the critical C&Q phase of project delivery, ensuring compliant, on-time, and on-budget execution while maintaining the highest standards of quality and safety. You will collaborate closely with project management teams, manufacturing operations, quality partners, site leadership, and external service providers to translate regulatory requirements and operational needs into innovative, practical solutions. This position offers the opportunity to make a direct impact on Roche's ability to manufacture life-changing medicines by ensuring our facilities and systems are rigorously validated and ready to support GMP operations globally.

The Opportunity
 

You will serve as Sub-Project Manager for Commissioning & Qualification Engineering, leading cross-functional teams through all phases of C&Q delivery while maintaining accountability for scope, budget, schedule, and compliance with Roche's quality and engineering standards. Your leadership will ensure that each project achieves target functionality, regulatory compliance, and operational excellence while fostering a collaborative, high-performing team environment. Key accountabilities include:

• You will lead and build engaged cross-functional C&Q project teams by setting clear expectations, motivating team members, facilitating strong communication, and making decisive decisions that drive alignment and accountability across disciplines

• You will develop and execute comprehensive C&Q strategies aligned with risk-based approaches (ASTM E2500), including scope definition, detailed work breakdown structures, resource planning, realistic scheduling, and cost estimating for mid to large-sized capital projects

• You will drive stakeholder alignment and maintain close coordination with project management, manufacturing operations, quality partners, site leadership, and external contractors to ensure integrated execution and early identification of risks and deviations

• You will manage the full C&Q project lifecycle—from options analysis and planning through detailed execution, contractor oversight, safety program deployment, training coordination, and handover—ensuring compliance with Roche PQS, Engineering Manual, and all applicable regulations

• You will proactively monitor project performance against plan, provide regular status updates on progress, resource demand, schedule changes, and risks, and lead corrective actions to maintain on-time, on-budget delivery

• You will onboard, mentor, and manage C&Q team members and external contractors with clear technical guidance, performance monitoring, and accountability for contractual obligations and behavioral expectations

• You will champion innovation and best practices in C&Q project management methodologies, challenging the status quo constructively to identify more effective ways of working and communicating improvements across the project team and broader organization

Who You Are

• You hold a Bachelor's degree in Engineering, Quantity Surveying, or related field with 8+ years (6 plus Masters) of experience in capital project management, Commissioning, Qualification, and Validation within pharmaceutical or biopharmaceutical sterile drug product manufacturing environments, with demonstrated expertise in GMP facilities, utilities, automation systems, and packaging operations

• Proven leadership of cross-functional, matrixed teams with excellent collaboration, communication, and team-building skills; ability to influence and partner effectively with internal stakeholders (manufacturing, quality, site operations, project management) and external service providers across culturally diverse, multi-level organizational environments

• Strong project management acumen including proficiency in advanced planning tools, risk-based methodologies, work breakdown structures, resourcing, estimating, and schedule development; demonstrated track record of delivering complex projects on time and within budget

• Deep pharmaceutical regulatory knowledge and compliance expertise (FDA, EMA, ICH) combined with in-depth understanding of manufacturing operations, end-user needs, and the ability to a