Roche · Welwyn ·
Lead global patient-safety operations for medical devices, overseeing ICSR intake, case processing, and compliance with regulations like MDR and IVDR while driving process improvements and AI-enabled safety systems.
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Patient Safety Operations, Central Operations is responsible for the intake, processing and submission of ICSRs and device safety reports using current and future safety systems and vendors/service providers.
The Principal job is accountable for:
Driving the development and delivery of Central Operations strategies, and across wider Patient Safety Operations, working across a matrix organization and aligning with other functions.
Ensuring inspection readiness across Patient Safety Operations, and maybe the primary point of contact (POC) for audits and inspections within Patient Safety Operations.
In conjunction with relevant Global Process Owners (GPOs), leading change initiatives and improvements to the Patient Safety Operations processes (e.g. impact assessment of revised legislation in reference to process changes and training), collaborating and obtaining endorsement from the GPO for major changes in the business process affecting the global process. Responsible for synchronising process improvement plans with other process owners within the value chain and other interfacing processes.
Provide subject matter expertise into the design and improvement of processes, and appropriate documentation, including development of metrics, KPIs and business information to support decision making.
Governance of the processes under the accountability of Patient Safety Operations process in collaboration with relevant stakeholders.
Partnering closely with GPOs and providing support through the BPO network, for ensuring oversight of data delivery, data quality, proactive identification and resolution of issues, and continuous improvement.
Ensuring robust oversight of delivery where vendor services are utilised.
Partner and influence globally, both across and outside Roche in the use of relevant new methods and technologies (e.g. AI) for safety data processing.
Detect and escalate issues impacting global PV processes or potentially affecting multiple Affiliates, acting as a single voice to represent continuous improvement initiatives and significant process changes.
Lead and sponsor large cross-functional PV improvement projects, identifying impacts on stakeholders (including Affiliates) and overseeing change management and communication strategies to ensure successful implementation.
We are specifically searching for a Principal who can take on the role of a ‘Business Process Owner for Medical Devices’ which includes responsibility for:
End-to-end case processing business process ownership for pre-market medical device clinical investigation safety reporting and post-market medical device incident reporting
End-to-end process design, continuous improvement, and compliance with regulations and guidelines.
Oversight of service providers, including monitoring compliance of the case processing process via appropriate metrics/KPIs. This includes supporting the development and implementation of processes and relevant human interventions (e.g. human in the loop) activities for AI augmented activities that permit oversight of operational safety data delivery and quality.
Being the primary representative of the case processing process in audits and inspections. Work closely within Patient Safety Operations, and within a network of Global Process Owners, and sub-process owners and experts to establish ‘inspection readiness’ approaches to demonstrate safety data process delivery quality, when using new processing approaches (e.g. future AI enabled safety systems etc).
The job holder will be expected to have the following skills:
Strategic planning and implementation of improvements with proven abilities in managing objectives and priorities efficiently and to effective conclusions.
Employ a systems thinking and entrepreneurial mind-set.
Role model behaviours that deliver an agile organisational culture that is in line with the Roche values, Leadership Commitments and the PD/PDS Strategy.
Be an active member of the Patient Safety Operations management/coaching community; collaborating across the enterprise, role modeling systems thinking mindset.
Maintain oversight of QMS related processes within the group and drive an holistic approach across Central Operations and Patient Safety Operations.
Leadership:
Champions agile ways of working, encourages a culture of innovation, experimentation and autonomous decision making, provides strategic direction and credible leadership that promotes development, motivation and ongoing engagement, supports the team in defining priorities and goals in alignment with wider functional and cross-functional goals
Proven ability to lead global line or matrix teams in accordance with the Roche leadership commitments and values, and to work across geographic areas, business settings and cultures, including in a virtual environment.
Excellent team player, with a proven ability to effectively lead projects and teams.
Well developed influencing and negotiating skills, with the ability to influence at all levels of an organisation, without direct authority.
Good conflict management and resolution skills.
Creative problem solving in a complex, process-focused environment.
Excellent interpersonal skills, builds strong sustainable relationships with internal and external stakeholders, and ability to connect people, ideas and initiatives, facilitating relationship management and collaboration across the organisation
Ability to interact successfully with senior leaders on strategic/global projects and issues, demonstrating managerial courage
Proven track record of effective decision-making; makes good business decisions and exercises sound judgement
Education: Degree level qualification as minimum, strongly desired for a postgraduate degree (PhD, PharmD, MSc, MD) or qualification in vigilance
Experience, Skills, Knowledge:
Significant industry experience, preferably in areas relevant to pharmacovigilance or vigilance. Prior experience in business process management would be an advantage.
Deep knowledge of global regulatory obligations including ISO14155, ISO20916, 21 CRF part 812 and 820, EU Medical Device Regulation (MDR 2017/745), EU IVD Regulation IVDR (2017/746).
Travel Requirements: International travel required (approximately 10-20%)
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.