Principal Commissioning & Qualification Manager (m/f/d)

F. Hoffmann-La Roche AG; Mannheim; On-site; EUR 110,000 - 160,000; Full time

Job summary

F. Hoffmann-La Roche AG seeks a Principal Commissioning & Qualification Manager to lead cross-functional teams through the C&Q lifecycle for high-stakes projects in GMP manufacturing.

You will ensure on-time, on-budget delivery while upholding regulatory and quality standards, with travel up to 20% and on-site leadership in Mannheim or nearby sites. You will drive schedules, budgets, and risk mitigation, coordinating with project management, manufacturing, QA, and external partners to

Qualifications

• Degree in engineering, life sciences, or a related field (Bachelor’s with 6-8 years or Master’s with 5-7 years of relevant experience) or equivalent professional background.
• Strong hands-on experience in Commissioning, Qualification, and Validation (CQV) for systems and equipment, including sterile drug manufacturing, warehousing, utilities, and automation.
• Proven understanding of risk-based C&Q strategies (e.g., ASTM E2500) and global regulatory standards (e.g., FDA, EMA, ICH).
• Proven track record in applying modern project management tools, problem-solving, and driving change while balancing project risks.
• Excellent written and spoken English and German skills.

Responsibilities

• Lead and manage business-critical C&Q sub-projects (large local or international scope) supporting GMP manufacturing operations, affiliates, and CMOs.
• Proactively develop, align, and drive C&Q project schedules and resource plans, ensuring timely and budget-compliant delivery.
• Assign tasks according to strengths, provide technical guidance to mid-sized project teams, and foster a collaborative environment.
• Regularly communicate project status to key stakeholders and ensure seamless information flow across teams and external contractors.
• Ensure project strategies and deliverables adhere to global regulatory requirements and quality management systems.

Skills

CQV expertise

Project management

English & German

Leadership

Education

Engineering or Life Sciences degree

Bachelor/Master in related field

Tools

Regulatory standards (FDA/EMA/ICH)

Risk-based C&Q strategies

Job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Are you ready to lead large-scale engineering projects that deliver life-saving medicines to patients worldwide? Join our Global Engineering team as Principal Commissioning & Qualification (C&Q) Manager (m/f/d) and take full ownership of delivering compliant, high-stakes C&Q outcomes across Pharma Technical Operations (PT). In this pivotal role, reporting to the PTT Regional Lead of C&Q, you will lead complex, cross-functional teams through the critical C&Q phase of project delivery. You will ensure seamless, on-time, and on-budget execution while maintaining the highest standards of quality and safety. Acting as a primary C&Q expert and matrix leader, you will partner closely with project management, manufacturing operations, quality teams, site leadership, and external service providers to translate global regulatory requirements and operational needs into innovative, practical solutions.

The Opportunity

In this role, you will act as Sub-Project Manager for Commissioning & Qualification within Global Engineering, serving as the first-line technical expert across the full C&Q project lifecycle. Bridging global engineering standards with site-level execution, you will foster a collaborative, high-performing environment while taking full ownership of schedule, scope, and budget to deliver target functionality, regulatory compliance, and operational excellence.

• Project Leadership: Lead and manage business-critical C&Q sub-projects (large local or international scope) supporting GMP manufacturing operations, affiliates, and CMOs.
• Execution & Financial Responsibility: Proactively develop, align, and drive C&Q project schedules and resource plans, ensuring timely and budget-compliant delivery.
• Team Empowerment & Collaboration: Assign tasks according to individual strengths, provide technical guidance to mid-sized project teams, and foster a collaborative "one team" environment.
• Stakeholder Alignment: Regularly communicate project status to key stakeholders, offer proactive advice, and ensure seamless information flow across cross-functional teams and external contractors.
• Quality & Compliance Oversight: Ensure project strategies and deliverables strictly adhere to global regulatory requirements, industry standards, and quality management systems.

Who you are

• Education & Professional Experience: Degree in engineering, life sciences, or a related field (Bachelor’s with 6-8 years or Master’s with 5-7 years of relevant experience) or equivalent professional background within the pharmaceutical industry.
• CQV Expertise: Strong hands-on experience in Commissioning, Qualification, and Validation (CQV) for systems and equipment, including sterile drug manufacturing, warehousing, utilities, and automation.
• Regulatory & Methodological Knowledge: Proven understanding of risk-based C&Q strategies (e.g., ASTM E2500) and global regulatory standards (e.g., FDA, EMA, ICH).
• Project Management Skills: Proven track record in applying modern project management tools, problem-solving, and driving change while balancing project risks.
• Communication & Collaboration: Excellent written and spoken English and German skills, with the ability to navigate diverse cultural environments and partner effectively across organizational levels.
• Mobility & Project Presence: Flexibility and readiness to lead directly on-site (travel up to 20%), bringing key project milestones to life and staying hands-on during active design or construction phases.

This is a full-time (100%) role, locally based in Mannheim or Penzberg, with flexibility for deployment across potential future EU project locations.

Please have a look at our FAQs, you will find them via https://careers.roche.com/global/en/faq.

Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world.