Quality Assurance Manager Qualified Person
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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
As a Quality Assurance Manager Qualified Person at Roche Belgium you play a pivotal role in our mission to deliver life-changing medicines to patients with uncompromising quality. Joining our Pharma Quality Assurance team you will act as a guardian of compliance and excellence ensuring that every product reaching the Belgian and Luxembourg market meets the highest global and local regulatory standards.
You will thrive in a highly collaborative environment where your technical expertise directly translates into patient safety and trust.
The Opportunity
This is a unique chance to join a team of engaged colleagues who are passionate about your success and the well-being of our collaboration with your peer QP/RP in Quality Assurance you will:
Act as a recognized authority for GMP/GDP Quality Management ensuring our operations are always inspection-ready.
Help maintain and evolve our local Quality Management System (QMS) balancing business needs with strict compliance requirements.
Beyond your local peer group you will actively contribute to and leverage Roches extensive global quality network.
Lead essential processes for e.g. product recalls quality defects... and serving as a vital link to National Health Authorities.
Key responsibilities
Implement and oversee the application of GMP/GDP principles in strict alignment with EU and Belgian national legislation.
Manage the interface with the Federal Agency for Medicines and Health Products (FAMHP) coordinating timely responses to inspections and observations.
Work collaboratively within the affiliate to ensure all materials and operations comply with Roche corporate standards and local laws.
Proactively identify and communicate quality or regulatory risks to affiliate management to ensure rapid and effective resolution.
Who you are
You are a dedicated Quality professional who combines technical mastery with a resilient and curious mindset. You are looking for a company where you can grow your expertise and show up as your authentic self.
You hold a higher education degree in Industrial Pharmacy and are formally recognized as a Qualified Person (QP) by the FAMHP.
You bring a minimum of 3 years of experience in GMP/GDP Quality Management with a profound understanding of medicinal product legislation.
You demonstrate the flexibility to adjust to evolving regulations and the resilience to handle complex challenges in a timely efficient manner.
You possess a natural curiosity for digital tools and data using them to enhance decision-making and streamline quality processes.
You understand the broader market dynamics and customer needs ensuring that quality excellence supports sustainable business growth.
You are a team player who values diverse perspectives and can communicate complex technical requirements clearly and decisively.
You work smoothly across cultures in a global quality network interacting with both other affiliates and global quality functions.
You are proficient in Dutch and/or French (minimum level C2) and are fluent in English (minimum level C1).
Why Roche Belgium
At Roche your work makes a tangible impact on a healthier future. We redefine healthcare through sustainable action and innovation and we believe that starts with empowering you.
Culture of Trust: Thrive in an agile work environment where autonomy and decision-making are valued and your colleagues are invested in your success.
Lifelong Learning: We support your development through broad access to learning opportunities encouraging you to design your own unique career path.
Inclusion & Belonging: We celebrate your unique contributions ensuring you can show up as yourself in a culture rooted in respect and high performance.
Who we are
A healthier future drives us to innovate. Together more than 100000 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.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Manager
Key Skills
- Quality Assurance
- FDA Regulations
- Food Industry
- Food Safety Experience
- ISO 9001
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- QA/QC
- Selenium
- HACCP
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.
