Global Head Investigational Medicinal Products Quality

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

Who We Are:

Pharma Technical Operations (PT) is the organization that manufactures and delivers Roche’s ground-breaking therapies to more than 120 million patients around the world. PT is involved in producing every Roche medicine – from the development process through clinical trials – and continuing through product maturity. We make our medicines at 15 plants and 11 sites around the world. Our organization coordinates all aspects of production of Roche medicines in all disease areas and dosage forms. Pharma Technical Operations Quality (PTQ) ensures we deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Quality is a competitive advantage for Roche.

The Opportunity:

As the Global Head of Investigational Medicinal Products (IMP) Quality, you will set the strategic direction and drive effective delivery outcomes aligned with Pharma Vision 2029, R&D efficiency, and PT North Stars. Your primary responsibility will be to ensure investigational medicines and due diligence assets, meet regulatory and quality standards from early to late-stage clinical trials.

Key responsibilities include:

• Overseeing the IMP value chain of product, process, and operations.

• Establishing and implementing phase-appropriate strategies for IMP products and ensuring they comply with Health Authority expectations globally.

• Collaborating with global executives in PTQ, Pharma Cell & Gene Therapy (PTC) and Pharma Technical Development (PTD), leveraging your strategic influence as a key member of the PTQ and PTD Leadership teams.

• Managing External Quality IMP for Quality and Compliance decisions.

• Cultivating strategic partnerships across the Pharma value chain, including collaboration with Roche Early Research and Development (gRED/pRED), Global Product Strategy (GPS), Partnering, and Pharmaceutical Tech Operations (PT).

• Strengthening the collaborative network across the enterprise by working closely with PT Biologics and Synthetic Molecules R&D functions to ensure seamless pipeline delivery.

• Regularly engaging in executive decisions related to corporate partnerships, deals, and asset acquisitions will also be a key aspect of your responsibilities.

Leadership:

As a member of the PTQ and PTD Leadership Teams, you will drive the deployment of Pharma and PT strategies essential for advancing our diverse pipeline efficiently and effectively. To be effective in this role, you will be:

• Demonstrating outcome-driven leadership.

• Instilling proactive accountability within the organization.

• Championing Lean Leadership.

• Serving as a role model for PT community leaders in performance, financial performance, collaboration, organizational development, and business outcome.

• Supporting and evolving digital transformation, which includes the introduction of new quality systems, and other innovative and analytical technologies within quality and beyond.

This role is crucial to ensuring Roche's investigational medicines adhere to the highest quality standards and regulatory requirements. You will make decisions with the highest integrity and ethical standards, fostering a culture of continuous improvement and operational excellence. You will lead a team of quality employees based in South San Francisco (US), Penzberg (Germany), and Kaiseraugst and Basel (Switzerland).

Who You Are:

We are looking for an inspirational leader who brings excellence in people leadership, and excels at building, engaging, and developing high-performing teams across global and site functions and a multi-cultural environment. You should be putting emphasis on building strong, collaborative relationships and having excellent communication skills. Furthermore, this role requires you to be able to convey effectively controversial information and decisions.

Education and experience:

• B.S/M.S degree in Science, Drug Development, or Chemical Engineering with extensive experience in the pharma/biopharma industry; PhD is an advantage.

• Extensive understanding of technical development, FDA, EMA, ICH guidelines, and cGMP requirements. Proven track record of leadership role(s) in Quality and Compliance.

• Demonstrated successful leadership in complex multicultural organizations, managing and motivating people, financials, and business processes in dynamic environments.

• Able to work in fast-paced settings while upholding highest quality and safety standards; willingness to travel 50% of the time.

• Current or former Quality Operations & Release / Lot-disposition responsibilities, Qualified Person (QP) or Responsible Person (RP) are an advantage.

Location: Basel, Mannheim, Penzberg or South San Francisco

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more .

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.