Central Operations Principal- Bussines Process Owner

Roche; Welwyn; On-site; GBP 90,000 - 140,000; Full time

Job summary

Roche seeks a Central Operations Principal to drive end-to-end safety regulatory data delivery across products and partnerships. You will lead scheduling, data reconciliation, and report generation, ensuring quality and on-time delivery while aligning with PV legislation.

You will partner with Clinical Operations, Biometrics/Data Sciences, Regulatory, Medical Affairs and Quality in a global matrix, shaping process improvements and governance in a complex, international environment.

Qualifications

• Degree in life sciences (PhD/PharmD/MSc/MD or PV qualification strongly preferred).
• Substantial experience in pharmacovigilance, pharma development, or healthcare.
• Deep understanding of DSURs/PBRERs, clinical trial design/conduct/reporting, and SDLC/systems validation.
• Experience representing processes in regulatory authority inspections/audits and continual process improvement.
• Strong matrix management, negotiation, and cross-cultural collaboration in international environments.

Responsibilities

• Oversee end-to-end regulatory reporting delivery including scheduling, data reconciliation, report generation and validation.
• Lead cross-functional process improvement activities and drive reductions in cost and lead time.
• Establish robust process governance and monitor KPIs; oversee vendor delivery.
• Act as primary POC for regulatory inspections and audits; translate PV legislation into operational changes.
• Collaborate with Clinical Operations, Biometrics/Data Sciences, Regulatory, Medical Affairs and Quality at global and affiliate levels.

Skills

Regulatory reporting

Cross-functional collaboration

Leadership

Process ownership

Project management

Education

Life sciences degree

Postgraduate PV qualification

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

We 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?

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.

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.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd