Principal Commissioning and Qualification Manager

F. Hoffmann-La Roche AG; Holly Springs (MS); On-site; USD 109,000 - 204,000; Full time

Job summary

F. Hoffmann-La Roche AG seeks a Commissioning & Qualification Manager to lead complex cross-functional teams in Holly Springs, NC. This role is critical for delivering global manufacturing capital projects, ensuring compliance, quality, and safety.

The ideal candidate will have 8+ years of experience, a Bachelor's degree in Engineering, and fluency in German and English. Strong leadership, project management expertise, and regulatory knowledge are essential.

A competitive salary between $109,000 - $204,000 based on experience with potential bonus and standard benefits.

Qualifications

• 8+ years of experience in capital project management, commissioning, qualification, and validation.
• Demonstrated expertise in GMP facilities, utilities, and automation systems.
• Fluent in German and English, with excellent collaboration and communication skills.

Responsibilities

• Lead and build engaged cross-functional project teams from C&Q phase through delivery.
• Develop and execute comprehensive C&Q strategies aligned with risk-based approaches.
• Manage full C&Q project lifecycle, ensuring compliance and effective resource management.

Skills

Project management

Leadership

Communication skills

Team-building

GMP compliance

Problem-solving

Education

Bachelor's degree in Engineering or related field

Tools

Advanced planning tools

Job description

Job Summary

Three roles available; can be based in either Hillsboro, OR or Holly Springs, NC.

This role is a vital part of Roche's Global Engineering team, partnering with Pharma Technical Operations 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.

Key Responsibilities

• 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.

Qualifications

• You hold a Bachelor's degree in Engineering, Quantity Surveying, or a 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 advocate for operational requirements while ensuring all compliance obligations are met.
• Fluent in German and English (written and spoken) with cultural 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.

Salary and Benefits

Expected salary range for the primary locations (Hillsboro, OR and Holly Springs, NC): $109,000 - $204,000. Actual pay will depend on experience, qualifications, geographic location, and other factors approved by law. A discretionary annual bonus may be available based on individual and company performance. This position also qualifies for the benefits outlined here.

Other Information

Position: On‑site; no remote options available at this time. Relocation benefits are not approved for this posting.

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 disability status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in the online application process, please complete the Accommodations for Applicants form.