Quality Assurance Expert

Job description

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 Objectives and Scope of Position: ● Strategy/Execution Ratio: You will operate with a balanced focus between strategy and execution (50% Strategy / 50% Execution), driving long-term goals and executing business processes. ● Design and deliver Quality Strategies and conclusions for assigned entities/processes. ● Contribute to the delivery of PDQ work and the development of PDQ processes. ● Lead and participate in PDQ goals and initiatives and support regulatory authority inspections. ● Apply a risk-based approach to Quality Assurance strategies based on the Critical to Quality (CtQ) framework. ● Mentor and support the development of Quality Leads within the team. Summary of Main Responsibilities: ● Design and Implementation of Quality Strategies ○ Establish relationships with business stakeholders and lead the development of molecule/product/process/affiliate-level approaches with appropriate measures (CtQ Factors). ○ Analyze quality data to identify trends and risks, providing insights to business partners. ● Delivery of Activities to Assess Quality Status ○ Lead and perform complex audits and quality assessments. ○ Synthesize individual audit issues into systematic conclusions and present findings and associated risks to senior stakeholders, ensuring quality data fulfills regulatory requirements and supports organizational goals. ● Demonstration of Implementation to Health Authorities ○ Play a lead role in inspection preparation and management. ○ Provide training to staff and ensure relevant materials are prepared for regulatory review. ● Execution of PDQ Goals ○ Lead assigned goals and initiatives and drive the development or revision of PDQ processes. Networking: ● Maintain and influence partnerships with senior business stakeholders and PDQ domains. ● Facilitate cross-functional collaboration to ensure quality standards are met globally. Compliance: ● Expert knowledge in GxP regulations (NMPA, ICH guidance) and internal policies. ● Ensure all activities are conducted in compliance with regulatory and company requirements. Qualification, knowledge and experience: Minimum Qualification : ● Bachelor’s degree or equivalent in a scientific or quality-related field. Advanced degree preferred. Minimum Experience / Knowledge: ● Significant experience in the pharmaceutical / biotech / medical device industry, including knowledge of the end to end development and operationalisation of products, and the associated GxP regulations and considerations (e.g., GCP, IVD/MD Regulations). ● Bachelor’s degree or equivalent in a scientific or quality-related field or equivalent combination of education, training, and experience. ● Advanced degree in referenced fields preferred. ● Extensive experience in leading GxP audits and managing complex quality projects. ● In-depth knowledge of drug development processes and global regulatory landscapes. ● Good understanding of Information Systems, e.g., audit management and analysis reporting tools. ● Understanding of business operations and strategies. ● Fluency in written and spoken English; bi or multi-lingual skills are desirable. Personal competencies: ● Strong digital and data literacy ● Skilled in using and analyzing data to drive solutions. ● Advanced communication and presentation skills. ● Strong stakeholder management and engagement skills. ● Comfortable working with ambiguous and complex information and able to synthesize it into clear and concise points of view to influence decision-making and action-taking. ● Ability to influence with and without authority, and negotiate effective solutions. ● Proven critical thinking, analytical, problem-solving, and decision-making skills. ● Ability to work effectively in an international, multicultural matrix organization and as part of agile project teams. Demonstrates effective teamwork and collaboration skills. ● Agile and creative in designing analytical solutions. ● Experienced in leading global project teams, and strong project management skills. ● Strong organizational and execution skills, and demonstrated ability to work independently and proactively. ● Proven leadership and mentoring abilities. 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.