Principal Commissioning and Qualification Manager (Pharmaceutical)

TL;DR

Principal Commissioning and Qualification Manager (Pharmaceutical): Leading complex cross-functional teams through the C&Q phase of capital projects for global manufacturing operations with an accent on regulatory compliance and operational excellence. Focus on translating regulatory requirements into practical solutions and ensuring facilities are ready for GMP operations.

Location: On-site in Hillsboro, OR or Holly Springs, NC

Salary: $109,000 - $204,000

Company

hirify.global, a member of the Roche group and pioneer of the biotechnology industry, is dedicated to discovering and developing medicines for people with serious and life-threatening diseases.

What you will do

• Lead and build cross-functional C&Q project teams by setting clear expectations and driving accountability across disciplines.
• Develop and execute comprehensive C&Q strategies using risk-based approaches (ASTM E2500), including scope definition and resource planning.
• Manage the full C&Q project lifecycle from planning through execution, contractor oversight, and handover to GMP operations.
• Collaborate with project management, manufacturing, quality, and site leadership to ensure integrated execution and risk mitigation.
• Monitor project performance against budget and schedule, leading corrective actions to maintain on-time delivery.
• Mentor C&Q team members and manage external contractors with clear technical guidance and performance monitoring.

Requirements

• Bachelor's degree in Engineering or related field with 8+ years of experience (or Master's degree with 6+ years).
• Expertise in Commissioning, Qualification, and Validation within pharmaceutical sterile drug product manufacturing environments.
• Demonstrated experience with GMP facilities, utilities, automation systems, and packaging operations.
• Proven leadership of cross-functional, matrixed teams and ability to influence internal stakeholders.
• Deep pharmaceutical regulatory knowledge and compliance expertise (FDA, EMA, ICH).
• Fluent in German and English (written and spoken).

Culture & Benefits

• Direct impact on the ability to manufacture life-changing medicines.
• Collaborative, high-performing team environment.
• Discretionary annual bonus based on individual and Company performance.
• Comprehensive corporate benefits package.