Central Operations Principal- Bussines Process Owner

Roche Holding AG; Welwyn; On-site; GBP 90,000 - 130,000; Full time

Job summary

Roche is seeking a Central Operations Principal to act as the Business Process Owner for end-to-end safety regulatory data delivery within Patient Safety Operations. You will lead sourcing, preparing, and summarizing clinical trial information to produce DSURs and PBRERs across Roche products globally.

Key duties include owning end-to-end regulatory reporting, driving process improvement, governance of vendors, inspection readiness, and collaboration with Clinical Ops, Biometrics, Regulatory,

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.

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.
• 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. Lead cross-functional teams without direct line authority.

Skills

Leadership

Matrix management

Regulatory compliance

Process improvement

Cross-functional collaboration

Education

Life sciences degree

Postgraduate PV qualification

Tools

PV systems

Regulatory databases

Data management tools

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. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.