Principal QA Specialist (Multi-dose pens), 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 cartridge filling, inspections, assembly and packaging. You will manage end-to-end quality for these areas, collaborating closely with diverse partners, including MSAT, Operations, Warehouse, Engineering, Quality, QC, and Global teams, to guarantee strict adherence to all quality standards.

What You'll Do

• Quality by Design: Support the establishment and implementation of operational procedures for cartridge filling through packaging, 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. Utilize advanced tools to move beyond human error and identify true systemic vulnerabilities. Approve Deviations and CAPAs.
• Technical Expert & Problem Solver: Act as a subject matter expert and provide guidance on matters related to Filling, Inspection, Assembly, Packaging, and clean utilities, 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, and act as local Quality Product Owner.
• Manufacturing Process Oversight: Provide direct oversight of filling, visual inspection, device assembly and packaging and clean utility generation & distribution, including oversight of cleanroom processes and behaviors, sterilization cycles, labelling, serialization and validation activities.
• Digital Footprint: Serves as the Quality Assurance Owner and approver for supporting applications that enable the digital transformation of shop-floor processes, replacing traditional paper documentation.

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 cartridge sterile drug product manufacturing experience in either a manufacturing, QA Operations or MSAT role.
• Strategic and systems thinker with a compliance focus, anticipating technology trends and driving excellence in execution.
• Advanced GMP and quality regulation knowledge with experience participating in global regulatory inspections (FDA, EMA).
• Expertise in Quality Assurance, demonstrated by successful oversight of critical quality systems, including 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.
• Good understanding of Annex 1 and how to operationally comply with these regulatory requirements.
• Hands-on experience with SAP and MES.
• Ability to explain how a Business Process translates into a Digital Recipe.
• Ability to work in a dynamic and fast-paced environment while ensuring the highest quality and safety standards.