Commissioning & Qualification Regional Lead at Roche

Kaiseraugst, Aargau, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

30 Jul, 26

Salary

0.0

Posted On

01 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Commissioning, Qualification, Validation, Project Management, CAPEX, Biopharmaceutical Industry, GMP, Regulatory Compliance, Sterile Manufacturing, Utilities, Automation Systems, Strategic Planning, Financial Acumen, Team Leadership, Stakeholder Management, Process Standardization

Industry

Biotechnology Research

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 PTT Project delivery executes major CAPEX projects in the Pharma Division with focus mainly on Pharma Technical Operations (PT). Reporting to the Regional Head of Project Delivery, the C&Q Regional Lead oversees the delivery of Commissioning & Qualification (C&Q) for global CAPEX projects within specific geographical regions. This role is instrumental in cultivating a high-performing network of technical leaders and subject matter experts to drive CQV excellence and ensure regulatory compliance and speed-to-market. The Opportunity You provide leadership and oversight to C&Q in regional CAPEX projects, managing costs, timelines, and quality for a multi-billion CHF portfolio while leading and developing a regional team of 6-8 direct reports, providing intentional coaching, mentoring, and specialized onboarding. Your main responsibilities include: Oversee C&Q strategy development in early project phases, ensuring alignment with global standards and integration of lessons learned. Review project cost estimates and establish robust C&Q schedules to mitigate business risk and ensure successful completion. Drive internal resource planning and long-term staff development strategies in collaboration with the PTT Head of C&Q. Organize and participate in C&Q workshops to integrate new knowledge and feed improvements back into global processes. Ensure robust monthly reporting and status tracking are in place to identify and escalate project risks in a timely manner. Perform C&Q peer reviews to evaluate project status and opportunities while ensuring compliance across the full equipment lifecycle. Monitor global industry trends and drive the implementation of innovative, sustainable, and cost-effective qualification processes. Who you are You are a strategic systems thinker with a strong drive for execution and a compliance-focused mindset. You possess an exceptional executive presence and the ability to navigate complex organizational dynamics, influencing senior partners and stakeholders across the network. With a passion for innovation and collaboration, you excel at building organizational capability and motivating diverse technical teams to deliver their best in a fast-paced environment. In addition you will bring the following skills and experience: University Degree in Engineering, Science, or a related discipline with at least 10 years of experience in the biopharmaceutical industry with vast experience in Commissioning, Qualification, and Validation (CQV) for sterile manufacturing, utilities, facilities, and automation systems. In-depth knowledge of global regulations (FDA, EMA, ICH) and the application of industry best practices within a GMP environment. Proven track record in leading regional functions and managing a portfolio of large-scale capital projects. Strong business and financial acumen, with experience in contract negotiations and managing strategic service provider relationships. Ability to drive change and standardize processes, including the implementation of systems like eVal Roche. Flexibility and willingness to travel approximately 20% - 30%, including potential short-term assignments at project sites. Relocation benefits are not offered for this position. Are you ready to make a difference for our patients? We are looking forward to your application – join us now and become part of our journey! 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. We are Roche.

Responsibilities

The C&Q Regional Lead oversees the delivery of Commissioning and Qualification for global CAPEX projects while managing costs, timelines, and quality. They are responsible for leading a regional team, developing C&Q strategies, and ensuring regulatory compliance across the equipment lifecycle.