Central Operations Principal- Bussines Process Owner in Welwyn

### The PositionWe are seeking a Central Operations Principal to take on the role of Business Process Owner (BPO) for to drive operational strategy, innovation, and end-to-end execution of safety regulatory data delivery. Operating within Patient Safety Operations (PSO), you will lead the core remit for sourcing, preparing, and summarizing clinical trial information to produce mandatory aggregate safety reports (such as DSURs and PBRERs) across all Roche products and co-development partnerships worldwide. **Key Responsibilities** * **Process Ownership & Operational Delivery**: Oversee and manage end-to-end regulatory reporting delivery - scheduling, setup, scope definition, data reconciliation, report generation and validation, and support of cross-functional review of final safety regulatory documents. Ensure high quality, operational efficiency, and strict timeline adherence.* **Strategy, Optimization & Innovation:** Propose and lead cross-functional process improvement activities. Simplifying workflow, automating, evolving sourcing strategy and driving reductions in cost and lead time - without sacrificing quality..* **Governance & Vendor Oversight:** Establish robust process governance. Monitor, interpret and refine key metrics/KPIs to monitor process performance. Maintain oversight of service provider delivery.* **Inspection Readiness & Compliance**: Serve as a primary Point of Contact (POC) for regulatory authority inspections and internal/partner audits. Partner with Global Process Owners (GPOs) to translate revised PV legislation into smooth operational change initiatives.* **Matrix Leadership & Collaboration**: Partner with, and represent functions including Clinical Operations, Biometrics / Data Sciences, Regulatory, Medical Affairs, Clinical Science, and Quality - both at the global level and locally across the Affiliate network. Act as a key member of the Patient Safety Operations coaching community, leading and inspiring cross-functional teams without direct line authority. **Requirements & Qualifications** * **Education:** Degree in life sciences (Postgraduate qualification such as PhD, PharmD, MSc, or MD, or formal PV qualification is strongly preferred).* **Industry Experience:** Substantial experience in pharmacovigilance, pharma development, or healthcare—ideally with prior experience in business process management and global PV regulatory obligations.* **Domain & Data Knowledge:** Deep understanding of DSURs/PBRERs, clinical trial design/conduct/reporting, clinical databases/management systems, statistical trial analysis and reporting, and software development lifecycle (SDLC) / systems validation.* **Inspection & Process Expertise:** Direct experience representing processes in regulatory authority inspections/audits, paired with a strong track record in continuous process improvement.* **Leadership & Mindset:** Forward-looking, action-oriented, and agile approach. Strong matrix management, systems thinking, negotiation, and conflict-resolution skills to drive a positive organizational culture. Extensive experience working with and managing Service Providers, and working in an international environment across cultures and timezones. Ready to transform patient safety data and impact global health? Apply today to shape the future of safety operations at Roche. Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Welwyn. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process. #J-18808-Ljbffr