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 PositionQA Specialist (Senior/ Associate Principal)
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.
That’s what makes us Roche.
As a QA Specialist in the Quality Systems and Compliance department, you are responsible for providing quality oversight and managing all related activities in line with Roche policies, standards, procedures, and Global cGMPs. Your functional duties include managing regulatory inspections and corporate GMP audits, managing the internal inspection readiness program, and overseeing the systematic evaluation of new and emerging regulations. You'll also be responsible for supplier management, trending quality compliance performance, and acting as a regulatory liaison by addressing queries from Health Authorities and internal partners. Additionally, you will play a key role in leading the execution and ongoing monitoring of Quality System elements, including Quality Management Systems (QMS), Annual Product Quality Review (APQR), Management Review of Quality (MRoQ), Quality metrics and Quality Risk Management (QRM).
The Opportunity
Audit and Inspection Management: Oversee regulatory inspections, internal and external audits, and manage the site's self-inspection program to drive continuous improvement.
Inspection Readiness: Develop and lead all site inspection readiness activities, including managing responses and mitigation plans for any observations.
Compliance Risk Management: Manage the compliance risk program, keeping the site informed about new requirements and emerging trends.
Supplier Quality: Support GxP supplier management and collaborate with the Global Supplier Quality team to maintain GxP agreements.
Regulatory Liaison: Act as a key liaison with PT Regulatory, coordinating between the site and PTR, and managing import and distribution licenses with affiliates.
Quality Systems Oversight: Manage the site's Quality Systems program to ensure it's effective, efficient, and compliant with all relevant regulations.
Risk Management: Oversee the risk management program to ensure potential product and patient risks are systematically assessed and documented.
Continuous Improvement: Ensure the continuous improvement of the Quality Management System (QMS) processes, including the Site Master File, MRoQ, Quality Risk Management, and APQR.
Who you are
Education and Experience: A degree in Science or Engineering with a minimum of five years of relevant experience in a pharmaceutical setting.
Industry Knowledge: Strong understanding of Quality System principles, cGMP, and both local and international regulations, with a familiarity with Operations.
Audit and Compliance Expertise: Proven knowledge of audit or inspection management and a strong analytical ability to interpret and apply quality standards.
Leadership and Teamwork: A detail-oriented leader with excellent communication skills who can work both independently and collaboratively under pressure.
Professional Skills: Demonstrated ability to make sound decisions, manage priorities, and build strong relationships to drive results.
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.
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