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

Roche Diagnostics GmbH; Mannheim; On-site; EUR 120,000 - 180,000; Full time

Job summary

Roche Diagnostics GmbH in Mannheim seeks a Principal Commissioning & Qualification Manager to lead large-scale C&Q projects across Pharma Technical Operations, ensuring compliant, on-time and on-budget delivery.

You will partner with PM, manufacturing, QA, site leadership, and external providers to translate regulatory requirements into practical solutions, with travel up to 20% and on-site leadership in GMP environments.

Qualifications

• Degree in engineering, life sciences, or related field with 6–8 years (Bachelor) or 5–7 years (Master) experience.
• Strong CQV experience for systems/equipment including sterile manufacturing, warehousing, utilities, and automation.
• Solid understanding of risk-based C&Q strategies and global regulatory standards (FDA, EMA, ICH).
• Proven project management skills with ability to balance scope, schedule and budget.
• Excellent English and German communication, with cross-functional collaboration.
• Willingness to travel up to 20% and on-site deployment in Mannheim or Penzberg.

Responsibilities

• Lead large-scale C&Q sub-projects supporting GMP manufacturing operations.
• Develop and drive project schedules and resource plans to ensure on-time delivery.
• Provide technical guidance to project teams and foster a one-team environment.
• Align stakeholders and maintain cross-functional information flow.
• Ensure compliance with global regulatory requirements and quality systems.

Skills

CQV expertise

Regulatory knowledge

Project management

English & German

Travel readiness

Education

Degree in engineering or life sciences

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.

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.

Your contact to us! With people. For people.

Do you need further support?

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.