Head of Quality Fundamentals, PTQ

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PTQ has a critical role in delivering safe and efficacious medicines to patients. To ensure we meet our commitment to the Roche Pharma Vision, we are evolving to become a more flexible, efficient, and collaborative organization. We are seeking a new senior member of our leadership team by looking for a Head of Quality Fundamentals. Reporting to the Global Head of PT Quality and Compliance, members of the Leadership Team will play a crucial role in supporting PTQ pursue its vision; 'All Value. Zero Waste. For Patients', and your energy and drive will inspire colleagues to discover new ways of 'radically simplifying' and 'pioneering for excellence'. The Leadership Team must collectively shape and execute Global Quality and Compliance strategies in alignment with the PT strategy, and ensure PTQ delivers its commitment to the Pharma Vision.

The position Head of Quality Fundamentals is a senior executive role and accountable for the fundamental Quality System and Quality Management aspects of quality and compliance activities throughout PT. This role is critical within the Roche Pharma ecosystem and a key leader in ensuring the continued delivery of safe medicines to patients.

The successful candidate will be accountable for:

1. Establishing and architecting PT’s fit-for-purpose Pharmaceutical Quality Management System which describes how we comply with global Health Authority and ISO requirements and accompanying Quality IT systems which enable compliance.
2. Ensuring and maintaining the health of the Quality Management system and accompanying Quality IT systems.
3. Auditing and monitoring process performance, quality system health and product quality which drives actions to improve and sustain global quality and compliance.
4. Implementing robust risk management to realize proactive mitigation of risks before they become issues.
5. Ensuring comprehensive knowledge management that enables a learning organization.
6. Lead an empowered area with a wide range of expertise (coming from multidisciplinary functions) to ensure “Right to Operate” by implementing a Quality and an End-to-End mindset.
7. Orchestrate priorities of our changing portfolio towards resilient supply and launch excellence in collaborations with MUs and Development functions.
8. Actively partner with respective stakeholder/s to drive One Quality Voice and ensure strategic alignment (MUs, Development Functions).
9. Drive convergence between different Site Q functions with a network mindset and continuous improvement for key Quality and GMP operational aspects.
10. Own / responsible for the compliance and adherence to HA standards and expectations. Operates in compliance with international GMP Standards.
11. Budgeting and Financial Performance: Accountable for overall budget and financial performance of assigned area and jointly responsible for performance of PTQ as a whole.
12. Organization and Resources: Directly responsible for staffing, talent management, budgeting and resource allocation.
13. Ensure area operations meet global standards/principles with regards to organization, personnel, qualification, training, procedures, processes, performance, productivity.
14. Evaluate Quality performance (KPIs and Quality reporting) in the assigned area and for the entire PTQ, proactively involved to enable progress on projects/initiatives as well as issues/Quality related escalations that might arise.

You are a visionary leader, adept at translating strategy into actionable and measurable execution with 10 or more years of experience in a management role. You empower your team, creating an environment where people thrive and develop.

You have a track record in leading Quality Management Systems on a global scale, leading a large global team in a complex, matrixed environment, and have a deep expertise in successfully leading Inspections and Quality Audit.

You further have experience in operational manufacturing and/or quality from your time at a manufacturing site. Additionally, you will bring a comprehensive compliance background and technical knowledge collected with 15 or more years of experience in the Pharmaceutical/ BioPharmaceutical industry. Bachelor’s in Life Sciences, Business or Engineering, Master in Business or Life Science preferred.

In addition:

1. You are a leader that can nurture an environment where people feel included, feel safe to learn through experimentation, feel able to be themselves and have the opportunity to do their best work.
2. You will be noted for your ability to inspire colleagues, keeping them focused on a clear vision, and a talent for coaching teams to innovate and look for ways to simplify, and pioneer technical excellence.
3. You have a well-established network across the Pharma Industry and can readily build one quickly within Roche/Genentech. This role requires you to collaborate, influence and build trust across levels within an international and cross-functional environment.
4. You bring a significant amount of business acumen, a solution-oriented mindset, and an ability to stay focused in ambiguous and pressured situations.
5. You bring outstanding communication skills.
6. You bring experience in site and global roles with a demonstrated ability to lead large, complex and collaborative global organizations.

As Head of Quality Fundamentals, you will contribute to develop solutions that are as global as possible, but as individual as necessary for our team, site or global function.

Roche is strongly committed to a diverse and inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing diversity enables us to create a great place to work and to innovate for patients.

Are you ready to apply? - Do you have a Network Mindset to follow 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 help others”?

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.

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.

Roche is an Equal Opportunity Employer.