Director of Quality Assurance Fundamentals

At F. Hoffmann-La Roche Gruppe, we prioritize diversity, equity, and inclusion, reflecting the communities we serve. In the realm of global healthcare, diversity is a vital component of our success. We believe that inclusion is essential for understanding the diverse healthcare needs of individuals. Together, we celebrate uniqueness and share a commitment to outstanding care. Every voice matters at Roche.

PTQ plays a pivotal role in delivering safe and effective medicines to patients. To fulfill our commitment to the Roche Pharma Vision, we are transforming into a more adaptable, efficient, and collaborative organization. We are in search of a new senior leader for our team, specifically a Director of Quality Assurance Fundamentals. Reporting to the Global Head of PT Quality and Compliance, this leadership role is crucial in guiding PTQ towards its vision: 'All Value. Zero Waste. For Patients'. Your enthusiasm and motivation will inspire colleagues to explore innovative ways of 'radically simplifying' and 'pioneering excellence'. The Leadership Team is responsible for shaping and executing Global Quality and Compliance strategies in alignment with the PT strategy, ensuring PTQ meets its commitments to the Pharma Vision.

The Director of Quality Assurance Fundamentals is a senior executive position responsible for overseeing the fundamental Quality System and Quality Management aspects of quality and compliance activities across PT. This role is essential within the Roche Pharma ecosystem and a key leader in ensuring the ongoing delivery of safe medicines to patients.

The successful candidate will be responsible for:

1. Designing and implementing a fit-for-purpose Pharmaceutical Quality Management System that outlines compliance with global Health Authority and ISO standards, along with supporting Quality IT systems.
2. Maintaining the integrity of the Quality Management system and associated Quality IT systems.
3. Conducting audits and monitoring process performance, quality system health, and product quality to drive improvements and sustain global quality and compliance.
4. Implementing robust risk management strategies to proactively mitigate risks before they escalate into issues.
5. Facilitating comprehensive knowledge management to foster a learning organization.
6. Leading a diverse team with expertise from various functions to ensure a 'Right to Operate' by adopting a Quality and End-to-End mindset.
7. Coordinating priorities within our evolving portfolio to achieve resilient supply and launch excellence in collaboration with MUs and Development functions.
8. Partnering with relevant stakeholders to promote a unified Quality Voice and ensure strategic alignment (MUs, Development Functions).
9. Driving convergence among different Site Q functions with a focus on continuous improvement for key Quality and GMP operational aspects.
10. Ensuring compliance with Health Authority standards and expectations, operating in accordance with international GMP Standards.
11. Managing budgeting and financial performance, being accountable for the overall budget and financial outcomes of the assigned area while jointly responsible for PTQ's overall performance.
12. Overseeing organization and resources, including staffing, talent management, budgeting, and resource allocation.
13. Ensuring that area operations align with global standards regarding organization, personnel, qualifications, training, procedures, processes, performance, and productivity.
14. Evaluating Quality performance (KPIs and Quality reporting) in the assigned area and across PTQ, actively engaging to facilitate progress on projects/initiatives and addressing any Quality-related escalations.

You are a visionary leader with the ability to translate strategy into actionable and measurable outcomes, possessing over 10 years of experience in a management role. You empower your team, fostering an environment where individuals thrive and develop.

Your background includes leading Quality Management Systems on a global scale, managing a large global team in a complex, matrixed environment, and possessing deep expertise in conducting Inspections and Quality Audits.

Additionally, you have experience in operational manufacturing and/or quality from your tenure at a manufacturing site. You bring a comprehensive compliance background and technical knowledge, accumulated over 15 years in the Pharmaceutical/BioPharmaceutical industry. A Bachelor's degree in Life Sciences, Business, or Engineering is required, with a Master's in Business or Life Sciences preferred.

Moreover:

1. You are a leader who cultivates an environment where individuals feel included, safe to learn through experimentation, and empowered to be their authentic selves while performing at their best.
2. You are recognized for your ability to inspire colleagues, maintaining focus on a clear vision, and your talent for coaching teams to innovate and seek simplification while pioneering technical excellence.
3. You possess a well-established network within the Pharma Industry and can quickly build connections within Roche/Genentech. This role requires collaboration, influence, and trust-building across various levels in an international and cross-functional environment.
4. You demonstrate significant business acumen, a solution-oriented mindset, and the ability to remain focused in ambiguous and high-pressure situations.
5. You possess exceptional communication skills.
6. You have experience in both site and global roles, demonstrating the ability to lead large, complex, and collaborative global organizations.

As the Director of Quality Assurance Fundamentals, you will contribute to developing solutions that are as global as possible while being tailored to the specific needs of our team, site, or global function.

F. Hoffmann-La Roche Gruppe is deeply committed to fostering a diverse and inclusive workplace. We strive to build teams that reflect a variety of backgrounds, perspectives, and skills. Embracing diversity allows us to create an exceptional work environment and drive innovation for patients.

Are you ready to explore this opportunity? - Do you embody a Network Mindset that aligns with the Pharma Operating Principle: 'I act on behalf of the whole company, not just my team. I consider the impact of my decisions and actions on the enterprise. I see the bigger picture, make connections, and share ideas that may assist others'?

At Roche, over 100,000 individuals across 100 countries are advancing the frontiers of healthcare. Together, we have become one of the world's leading research-focused healthcare groups. Our success is rooted in innovation, curiosity, and diversity.

Basel serves as the headquarters of the Roche Group and is one of its most significant centers for pharmaceutical research. More than 10,700 employees from over 100 countries collaborate at our Basel/Kaiseraugst site, one of Roche's largest facilities.

In addition to extensive development and training opportunities, we offer flexible working arrangements, 18 weeks of maternity leave, and 10 weeks of gender-independent partnership leave. Our employees benefit from various on-site services, including childcare facilities, medical services, restaurants, and cafeterias, as well as numerous employee events.

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

Roche is an Equal Opportunity Employer.