Senior QA Specialist, CVRM
Roche
Summary
We are looking for a highly impactful Senior QA Specialist with 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 all manufacturing and warehouse operational activities. You will also provide QA oversight for support functions and directly collaborate closely with cross-functional partners to guarantee strict adherence to quality standards.
Job description
What You'll Do
- Manufacturing Process Oversight: Provide direct oversight of compounding, filling, visual inspection, device assembly, packaging, clean utility generation and distribution, and warehouse activities, including cleanroom behaviors, sterilization cycles, labeling, serialization, and validation operations.
- Investigations & Deviations: Serve as the QA center of excellence for major investigations, CAPAs, and effectiveness checks. Act as Reviewer and Approver for deviations, leading or supporting complex investigations, determining root causes, and ensuring implementation of effective corrective and preventive actions. Act as a deviation coach and ensure investigations are thorough and robustly documented.
- Compliance & Change Control: Participate in equipment and process risk assessments, review and approve operational change controls, approve process parameter optimizations, minor equipment adjustments, and continuous improvement projects.
- Product Release & Incoming Goods: Perform incoming goods release, intermediate & finished product release, and review of all manufacturing activities. Execute quality evaluations, release holds, and final disposition reviews for outgoing drug product shipments.
- Quality Management: Approve site procedures and drive operational efficiency by regularly evaluating and refining processes and standard operating procedures (SOPs).
- Inspection Support: Support inspection readiness, participate during regulatory inspections, and support review/approval of dossier sections.
- Cross-Functional QA Support: Provide QA oversight for sample management, monitor operational metrics, and analyze quality data. Extend QA guidance to support functions, including MSAT, IT/OT, Supply Chain, and Facilities/Engineering.
Who You Are
- Bachelor's degree in a scientific or engineering discipline (a Master's or advanced degree is strongly preferred).
- Minimum of 6–8 years of experience in a GxP environment, with at least 3 years in an operational role within QA Operations, Manufacturing, or MSAT, specifically supporting sterile drug product manufacturing or device assembly.
- Proven expertise in Quality Assurance oversight, including direct responsibility for major deviations, root cause analysis, complex investigations, CAPA effectiveness, and final batch disposition/product release.
- In-depth understanding of global regulatory standards, including EU Annex 1 and FDA/EMA regulations, with demonstrated experience participating in global regulatory inspections.
- Practical experience with GxP digital tools and automated systems (e.g., SAP, MES), with the ability to translate business processes into compliant digital workflows and enforce ALCOA+ data integrity principles.
- Strong mindset for Quality Risk Management (QRM) and Operational Excellence, with experience driving continuous improvement and embedding lean quality practices in high-volume manufacturing.
- Strategic, systems thinker with excellent technical writing skills and a collaborative approach to cross-functional problem-solving in a fast-paced environment.
Requirements
- Bachelor's degree in a scientific or engineering discipline
- Master's or advanced degree strongly preferred
- Minimum of 6–8 years of experience in a GxP environment
- At least 3 years in an operational role within QA Operations, Manufacturing, or MSAT
- Experience supporting sterile drug product manufacturing or device assembly
- Proven expertise in Quality Assurance oversight
- Direct responsibility for major deviations, root cause analysis, complex investigations, CAPA effectiveness, and final batch disposition/product release
- In-depth understanding of global regulatory standards, including EU Annex 1 and FDA/EMA regulations
- Demonstrated experience participating in global regulatory inspections
- Practical experience with GxP digital tools and automated systems (e.g., SAP, MES)
- Ability to translate business processes into compliant digital workflows
- Enforce ALCOA+ data integrity principles
- Strong mindset for Quality Risk Management (QRM) and Operational Excellence
- Experience driving continuous improvement and embedding lean quality practices in high-volume manufacturing
- Excellent technical writing skills
- Collaborative approach to cross-functional problem-solving
Benefits
- Discretionary Annual Bonus
Company overview
Roche is a Swiss multinational healthcare company and a global pioneer in pharmaceuticals and diagnostics, founded in 1896 and headquartered in Basel, Switzerland. As the world's largest biotech company and the fifth-largest pharmaceutical company by revenue, Roche operates through two primary divisions: Pharmaceuticals and Diagnostics. The company is renowned for its leadership in personalized healthcare, combining strengths in both drug development and diagnostic testing to deliver tailored treatments for patients. Roche maintains a strong focus on oncology, immunology, infectious diseases, ophthalmology, and central nervous system disorders, with a portfolio that includes over 30 medicines on the World Health Organization's Model Lists of Essential Medicines. The company owns significant subsidiaries including Genentech, Chugai Pharmaceuticals, Ventana Medical Systems, and Foundation Medicine. With approximately 103,000 employees worldwide and operations in over 100 countries, Roche has established itself as a leader in cancer treatments globally while maintaining a robust pipeline of innovative therapies and diagnostic solutions. The company's commitment to sustainability has been recognized through ten consecutive years as Group Leader in the Dow Jones Sustainability Indices within the Pharmaceuticals, Biotechnology & Life Sciences Industry.