Principal QA Specialist (Assembly & Packaging), CVRM

The Opportunity

We are looking for a highly impactful Principal QA Specialist with extensive experience, a robust risk-based operational focus, and a strong compliance mindset. This critical role is essential for guaranteeing the delivery of top-quality products, consistently meeting global regulatory requirements and Roche's stringent internal standards. In this role you will be a member of the QA team providing quality oversight for manufacturing and supporting processes, specifically for Assembly, Packaging and Warehouse operations.

What You'll Do

• Quality by Design: Support the establishment and implementation of operational procedures for Assembly, Packaging and Warehouse operations, ensuring appropriate risk-based controls are in place to embed Quality by Design into operational processes.
• Quality Management: Approve procedures and drive continuous improvement by regularly assessing and refining processes and procedures to maximize efficiency and effectiveness.
• Digital Quality: Work closely with the MES and SAP teams to design recipes and Manufacturing Batch Records and ensure master data aligns with validated process parameters.
• Release by Exception: Design the logic for Release by Exception, defining which critical process parameters must be automatically verified to allow for accelerated batch disposition.
• Design & Commissioning Phase: Support equipment and process design reviews, FAT, SAT and commissioning activities to design fit for purpose, lean, operational processes in advance of PQ.
• Investigations: Support or lead complex investigations, determining root causes and ensuring the implementation of effective Corrective and Preventive Actions. Approve Deviations and CAPAs.
• Technical Expert & Problem Solver: Act as a subject matter expert and provide guidance on matters related to Assembly and Packaging, monitoring data and trends and identifying areas for improvement.
• Inspection support: Support inspection readiness, participate during regulatory inspections and support review/approval of the dossier sections.
• Compliance: Participate in equipment and process risk assessments, approve change controls.
• Manufacturing Process Oversight: Provide direct oversight of device assembly and packaging and process support operations, including labelling, serialization and validation activities, as well as warehouse operations and material movement throughout the facility.
• Digital Footprint: Serve as the Quality Assurance Owner and approver for supporting applications that enable the digital transformation of shop-floor processes.

Who You Are

• Bachelor's degree in a scientific discipline (a graduate or higher-level degree strongly preferred).
• Minimum of 8-10 years in a GxP environment, with at least 4 years of Device assembly and packaging experience in either a manufacturing, QA Operations or MSAT role.
• Experience with pre-filled syringes or autoinjectors preferred.
• Strategic and systems thinker with a compliance focus.
• Advanced GMP and quality regulation knowledge with experience participating in global regulatory inspections (FDA, EMA).
• Expertise in Quality Assurance, including oversight of critical quality systems such as deviation management, CAPA, and product release processes.
• Experience leading complex investigations and strong technical writing skills.
• Experience embedding operational excellence in complex, large-scale manufacturing environments.
• Experience implementing and driving a continuous improvement culture.
• Hands-on experience with SAP and MES.
• Ability to explain how a Business Process translates into a Digital Recipe.