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The Position
The Opportunity
At Roche, our commitment to quality in Pharma Development is unwavering. We aim to deliver confidence in the integrity of our data, agility in our processes, and transparency with regulators, patients, and society. As a Quality Excellence Lead, you will play a pivotal role in driving excellence across our global quality landscape, from Good Clinical Practice (GCP) and Pharmacovigilance (GVP) to Medical Device Regulations (MDR) and beyond. Different roles are available to successful candidates, one of which includes Global Process Ownership for managing unplanned Quality Events. This is your chance to shape quality strategies and deliver impactful results for Roche’s portfolio of work.
Key Responsibilities:
1. Lead the development and implementation of strategies to enhance outcomes, productivity, and efficiency across Product Development Quality (PDQ).
2. Provide quality data to meet regulatory requirements while generating insights to catalyze key decisions.
3. Manage large-scale projects in international, multicultural matrix environments, ensuring alignment across the business.
4. Design and maintain methodologies for data analytics and regulatory compliance tools.
5. Drive knowledge management and organizational learning to deliver sustainable improvements.
6. Apply systems-thinking and strategic collaboration to streamline and accelerate quality outcomes.
7. Contribute to portfolio management, capability development, and the nurturing of organizational quality skills.
Who You Are
Essential Skills and Experience:
1. Strong technical expertise in areas like GCP, GVP, MDR, SaMDs, QMS, or Risk-Based Quality Management (RBQM).
2. Skilled in Portfolio Management methodologies and / or developing learning strategies to drive organisational capability development.
3. Proven ability to lead large, complex projects while fostering effective decision-making and collaboration.
4. Demonstrated critical thinking, problem-solving, and adaptability in challenging situations.
5. Skilled in stakeholder engagement, influencing, and negotiation.
6. Digital and data-literate, with the ability to apply insights for impactful outcomes.
Competencies You'll Demonstrate:
1. Critical thinking and a proactive risk-based approach.
2. Inclusive leadership with a focus on coaching and mentoring.
3. Strategic decision-making aligned with business value.
4. A change mindset and an innovative, data-driven approach.
5. Exceptional communication and collaboration skills.
Your Application
Please kindly provide a cover letter alongside your CV.
The interview process will consist of a screening video interview, followed by a case study presentation as part of the interview process.
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