Principal Commissioning and Qualification Manager (Pharmaceutical)

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.