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 Roches 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 Roches 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 Roches 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 lifecyclefrom options analysis and planning through detailed execution contractor oversight safety program deployment training coordination and handoverensuring 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 Bachelors 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

• 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

The expected salary range for this position based on the primary location of Hillsboro OR and Holly Springs NC is $109000 - $204000. 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 in this link.

This is an on-site position; no remote options are 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 companys 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.

If you have a disability and need an accommodation in relation to the online application process please contact us by completing this form Accommodations for Applicants.