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Director of Quality Assurance Fundamentals

3 months ago

Mississauga, Ontario, Canada F. Hoffmann-La Roche Gruppe Full time

At F. Hoffmann-La Roche Gruppe, we champion diversity, equity, and inclusion, reflecting the communities we serve. In the realm of global healthcare, diversity is vital for 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.

The RolePosition OverviewGlobal Pharma Technical Quality & Compliance (PTQ) Insight

PTQ plays a pivotal role in delivering safe and effective medications to patients. To uphold our commitment to the Roche Pharma Vision, we are evolving into a more adaptable, efficient, and collaborative organization. We are in search of a senior leader to fill the role of Director of Quality Assurance Fundamentals. Reporting to the Global Head of PT Quality and Compliance, this leadership position is crucial in guiding PTQ towards its vision: 'All Value. Zero Waste. For Patients'. Your enthusiasm and leadership will motivate colleagues to explore innovative ways of 'radically simplifying' and 'pioneering excellence'. The Leadership Team must collaboratively shape and implement Global Quality and Compliance strategies aligned with the PT strategy, ensuring PTQ fulfills its obligations to the Pharma Vision.

Key Responsibilities

The Director of Quality Assurance Fundamentals is a senior executive role responsible for overseeing the foundational Quality System and Quality Management aspects of quality and compliance activities across PT. This position is vital within the Roche Pharma ecosystem and is a key leader in guaranteeing the continuous delivery of safe medications to patients.

The successful candidate will be responsible for:

  1. Designing and establishing a tailored 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 effective risk management strategies to proactively mitigate potential 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' through a Quality and End-to-End mindset.
  7. Coordinating priorities of our evolving portfolio to achieve resilient supply and launch excellence in collaboration with MUs and Development functions.
  8. Partnering with 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, accountable for the overall budget and financial outcomes of the assigned area, and jointly responsible for PTQ's overall performance.
  12. Overseeing staffing, talent management, budgeting, and resource allocation.
  13. Ensuring that area operations meet global standards regarding organization, personnel, qualification, training, procedures, processes, performance, and productivity.
  14. Evaluating Quality performance (KPIs and Quality reporting) within the assigned area and across PTQ, actively engaging in projects/initiatives and addressing any Quality-related escalations.
Candidate Profile

The ideal candidate is a visionary leader with the ability to translate strategy into actionable and measurable outcomes, possessing 10 or more years of experience in a management capacity. You empower your team, fostering an environment where individuals can thrive and grow.

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

Your background includes operational manufacturing and/or quality experience from a manufacturing site, complemented by a comprehensive compliance background and technical knowledge gained over 15 or more 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.

Additionally:

  1. You are a leader who cultivates an environment where individuals feel included, safe to learn through experimentation, and empowered to perform at their best.
  2. You are recognized for your ability to inspire colleagues, maintaining focus on a clear vision, and for your talent in 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 necessitates collaboration, influence, and trust-building across various levels in an international and cross-functional setting.
  4. You bring significant business acumen, a solution-oriented mindset, and the ability to remain focused in ambiguous and high-pressure situations.
  5. Your communication skills are exceptional.
  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 help develop 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 encompass a wide range of backgrounds, perspectives, and skills. Embracing diversity allows us to create an exceptional work environment and innovate for our patients.

Roche is an Equal Opportunity Employer.