International Quality Lead — Roche
NewCHF 68'000 - 103'000
Roche · Basel (BS)
- Location
- Basel
- Contract
- full-time
- Posted
- 2 days ago
SalaryCHF 68'000 - 103'000
Role overview
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.
- 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.
- Key Responsibilities:
- Drive Quality Strategies: Support the execution of risk-based Quality Assurance strategies and conclusions in predominantly Good Pharmacovigilance Practice (GVP) as well as Good Clinical Practice (GCP), using the Critical to Quality (CtQ) framework.
Main responsibilities
- Key Responsibilities:
- Drive Quality Strategies: Support the execution of risk-based Quality Assurance strategies and conclusions in predominantly Good Pharmacovigilance Practice (GVP) as well as Good Clinical Practice (GCP), using the Critical to Quality (CtQ) framework.
- Lead Global Audits: Plan, perform, and lead audits, grouping individual issues into systematic trends to provide valuable quality data that fulfils regulatory requirements.
- Partner with Stakeholders: Establish and maintain strong partnerships with business stakeholders, presenting audit observations and associated compliance risks clearly.
- Support Inspections: Play a key role in regulatory authority inspection preparation and management.
- Advance PDQ Processes: Participate actively in assigned departmental goals and initiatives, contributing directly to the continuous improvement of PDQ processes.
- Maintain GxP Expertise: Maintain deep awareness and expertise in global regulations (such as FDA, EU, and ICH guidance) across GCP, GVP, or Medical Device frameworks.
- Who You Are You are a proactive, analytical quality professional who thrives on transforming complex data into clear, actionable solutions.
- You are an excellent communicator, highly skilled at collaborating across cultures and influencing stakeholders at various levels with or without formal authority.
- You look for opportunities to develop your skills within an international team and are passionate about continuous growth. To be successful in this role, you bring:
Application process
- In this dynamic role, you will apply a risk-based approach to Quality Assurance using our Critical to Quality (CtQ) framework.
Additional details
- You look for opportunities to develop your skills within an international team and are passionate about continuous growth. To be successful in this role, you bring:
- Data & Digital Literacy: Excellent digital capabilities, with a good understanding of audit management and analytical reporting tools to drive data-led solutions. Critical Thinking: Proven problem-so
Notes and original content
- You look for opportunities to develop your skills within an international team and are passionate about continuous growth.
- To be successful in this role, you bring:
- Data & Digital Literacy: Excellent digital capabilities, with a good understanding of audit management and analytical reporting tools to drive data-led solutions.
- Critical Thinking: Proven problem-so
