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

F. Hoffmann-La Roche AG; Mannheim; On-site; EUR 110,000 - 140,000; Full time

Job summary

F. Hoffmann-La Roche AG in Germany seeks a Principal Commissioning & Qualification (C&Q) Manager to lead large-scale C&Q activities for GMP manufacturing, utilities, and related facilities.

You will manage cross-functional teams, ensure regulatory-compliant delivery, and drive on-time, on-budget project execution on-site at Mannheim or nearby sites. Fluent English and German are required, with willingness to travel up to 20% and to work hands-on during active design or construction phases.

Qualifications

• Degree in engineering or life sciences with pharma experience.
• Strong CQV experience for GMP manufacturing, utilities, and validation.
• Knowledge of FDA/EMA/ICH regulatory standards and ASTM E2500.
• Fluent English and German; willing to travel up to 20%.

Responsibilities

• Project Leadership: Lead large C&Q sub-projects for GMP manufacturing ops, affiliates, and CMOs.
• Execution & Financial Responsibility: Develop and drive C&Q schedules and resources to deliver on time and on budget.
• Team Empowerment & Collaboration: Assign tasks, guide project teams, and foster a one-team culture.
• Stakeholder Alignment: Report status to stakeholders and ensure information flow across cross-functional teams.
• Quality & Compliance Oversight: Ensure strategies comply with global regulatory requirements and QMS.

Skills

CQV Expertise

Project Management

English (fluent)

German (fluent)

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Life Sciences

Master's degree in Engineering or Life Sciences

Tools

Validation software

Automation systems

Job description

**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. **You will:** * **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. **Application documents - very pragmatic:**We ask you for a current **CV in English** and your official (educational) certificates/credentials. Further documents are not mandatory at the moment. Please note before sending your application that no further documents can be added afterwards.Apply now - we are looking forward to it!