Principal Commissioning and Qualification Manager

Genentech; Hillsboro (OR); On-site; USD 109,000 - 204,000; Full time

Benefits offered by this job

Relocation benefits

On-site position

Job summary

Genentech is seeking a Commissioning & Qualification Manager to lead cross-functional teams through C&Q delivery for capital projects, ensuring compliance with Roche PQS, Engineering Manual, and applicable regulations. You will manage scope, budget, and schedule, while driving risk-based strategies and vendor oversight to deliver GMP-ready facilities and systems for global operations.

You will partner with project management, manufacturing operations, quality, site leadership, and external

Qualifications

• Bachelor's degree in Engineering or related field with 8+ years of capital project management experience, Commissioning, Qualification, and Validation in pharma/biopharma environments.
• Strong leadership of cross‑functional teams with excellent collaboration and communication.
• Deep regulatory knowledge (FDA, EMA, ICH) and GMP facility experience.

Responsibilities

• Lead cross-functional C&Q project teams and set expectations for scope, budget, and schedule.
• Develop and execute C&Q strategies aligned with risk-based approaches and detailed work plans.
• Coordinate with PM, manufacturing ops, quality, site leadership, and external contractors for integrated execution.

Skills

Leadership

Cross-functional collaboration

PM/Project management

Regulatory knowledge

Communication

Education

Bachelor's degree in Engineering or related field

Job description

The Position

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 fieldwith 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 advocate for operational requirements while ensuring all compliance obligations are met


• Agility and the courage to drive change while balancing risk, innovation, and pacing for sustainable success; proactive relationship-building skills with customers, stakeholders, and team members at all organizational levels

The expected salary range for this position based on the primary location of Oregon is $109,000 - $204,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

This position also qualifies for the benefits detailed at the link provided below.

Benefits

This is an on-site position; no remote options are available at this time.

Relocation benefits are available for this posting.

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Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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