At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
The Regional Quality Responsible is an affiliate strategic quality partner role.
- Quality Management System: Responsible for implementing the Affiliate Quality Management System (QMS) and ensuring local Medical Compliance-related activities are delivered. Provide support in maintaining the affiliate LTO. Accountable for medical compliance reporting and inspection readiness, in alignment with local regulations and global standards.
- Product Quality System: Support the oversight of warehousing and distribution partners within the subregion on implementing, using, and continually improving a quality system to ensure compliance with local regulations and applicable Roche PQS requirements, and to ensure an uninterrupted supply of quality products to patients.
Your Role:
- QMS:
- Quality system Administration:
Lead Implementation of QMS in the Affiliate: ensuring effective local implementation of the QMS Framework by prioritizing simplification, efficient resource allocation and timely escalation of issues impacting efficiency or effectiveness to Global function (PDQ).
- Medical Compliance and Risk Management
- Lead the process to measure the overall Affiliate Medical Compliance status and take necessary actions, as well as contribute to the continuous improvement of the global QMS by providing Affiliate insights through appropriate internal pathways and systems. Lead the Affiliate Management Review (MRs) and Affiliate Medical Compliance Office (AMCO,), ensuring that key outputs are understood by senior management and appropriate decisions and actions are taken where necessary.
- Lead the Risk & Opportunity management and escalation process at local level to proactively identify, manage, mitigate and escalate Medical Compliance risks.
- Lead affiliate quality monitoring and support audits & inspections
- Other Responsibilities in Affiliate-Specific Business needs: Undertake other responsibilities as delegated by Country Medical Director (e.g., enablement of Local Digital Health solutions, RWE/D, MAP, work packages..)
- PQS:
- Warehousing and distribution partners:
- Support selection and management of new partners (due diligence phase, quality system management phase,..)
- Oversee closing of gaps and adherence to long-term GxP-Compliance Plans
- Act as first-level support for warehousing and distribution partners concerning product quality-related topics
- Execute training with individual partners based on their specific needs
- Others: support in preparation and facilitation of regional workshops, monitor health authority trends and discussions for the countries within the region, support Global Quality Manager in product quality data collection and interpretation
Who you are:
Qualifications / Experiences / Competencies
- University Degree in life sciences or similar Disciplines.
- At least 2 years of experience in a biopharmaceutical company or equivalent
- Understanding the Quality Principles of ISO standards.
- Experience in working with a cross-functional team and international network, preferably in a GxP function
- VACC Leadership Skills
- Strong partnering and networking capabilities, ability to influence without authority
- Excellent stakeholder (internal and external) engagement and practical collaboration skills
- Strategic mindset, systems thinking, enterprise mindset
- Understanding of Data Analytics and ability to derive Qualitative insights
- Familiar with the Agile methodology/tools, including innovative and creative thinking
- Strong verbal and written communication skills
- Ability to translate strategic objectives into operational goals to accelerate results
- Fluency in French and English
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.