Senior Quality and Systems Lead - Digital Health Technologies

United States of America, California, South San Francisco
Switzerland, Basel-City, Basel

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WHO WE ARE:


The Digital Health Technologies (DHP) group at Roche/Genentech is part of the Personalized Healthcare (PHC) Center of Excellence focusing on developing the next generation digital health platforms, tools and products for the future of medicine. Digital health promises to revolutionize how we diagnose disease, understand a patient’s disease course and response to treatment with unprecedented precision, and predict what treatment strategies are likely to be optimal. We are building a clinically validated, highly scalable and secure software platform that meet regulatory, quality, and privacy requirements. Our platform and services support Software as Medical Device (SaMDs), connected medical devices, and combination products.

DHP partners across the company with other Digital Health groups to advance digital health solutions which include hardware, software, applications, tools, and technologies to enable development of our therapies as well as more personalized care of patients across a range of therapeutic areas. Our primary focus is on the validation, scaling, and productization of digital health platforms, tools, and products; inclusive of late-stage development of novel digital biomarkers and endpoints, as well as the design, conduct, and analysis of analytical validation, clinical validation, and clinical utility studies to meet stakeholder needs and regulatory requirements, as appropriate.


The PHC Center of Excellence is focused on translating the promise of meaningful data at scale, advanced analytics, and digital technologies for drug development, and personalized patient care. 

THE POSITION:

The Platform Compliance and Strategy (PCS) group within DHP leads the team’s Quality Management System (QMS) strategy; coordinates product documentation (e.g., CSV validation, content validation for digital endpoints); secondary evidence generation needed for validation; and supports the lifecycle management of the products in our portfolio. Customer-focus throughout product development is key. Scaling from prototypes to commercial in-market deployment and making effective use of generated data are priorities. PCS also supports the greater Roche organization through early product consultation on Software as Medical Device (SaMD) products, creation of education materials on SaMD, providing insights and support to the Regulatory Policy teams, and leading research (or feedback) from key stakeholders (patients, regulators) on data privacy, regulation, and evidence requirements (both digital measures and the software system). 

We closely collaborate within Roche with our other DHP groups, clinical development functions, other digital health groups, functions and subject matter experts within the Personalized Healthcare area and the Research and Early Development organizations, Diagnostics, Pharma Partnering, and technical & technology functions, in order to define and execute the strategic direction of Digital Health to transform drug development and patient care. We externally partner with patient groups and health care providers, technology companies, regulatory and reimbursement authorities, legal manufacturers, policy makers and others.

In partnership with colleagues, the Senior Quality Specialist in Digital Health Technologies will spearhead the quality strategy for a robust, replicable and scalable platform that will host analytically and/or clinically validated software. The Senior Quality Specialist will be responsible for developing procedures and tools that ensure effective clinical, software code, and data oversight and documentation support for the lifecycle of every DHP product, in partnership with the Legal Manufacturer. This role has the potential to evolve into a formal leadership role to include a team of direct reports.

RESPONSIBILITIES:

Quality Management System (QMS) Assessment and Maintenance:

  • Collaborate with compliance experts across the business (PD Quality (PDQ), Roche Diagnostics Regulatory & Compliance) to develop QMS strategy and assess capabilities of Legal Manufacturer for each product
  • Assess the QMS needs for products in the DHP pipeline, and collaborate with stakeholder to enable early alignment of digital products with design controls
  • Partner with DHP’s Product Management and Architecture & Design groups to identify tools and processes for streamlined product compliance with quality management
  • Understand and support the local quality responsible (LQR) in implementing the Good Clinical Practice / Good Vigilance Practice (GCP/GVP) QMS requirements for the business and monitor progress
  • Work with departments to collect and compile data for quarterly reports for global and Roche Affiliate Management Review
  • Support LQR in liaising with Functions to ensure compliant Vendor Management processes are in place, and that there exists effective vendor oversight
  • Ensure that all processes are aligned with global Roche SOPs and any local requirements
  • Ensure this is done in compliance with the Roche Global Records Management Directive, in collaboration with the respective CoreMap Records Coordinator

Deviation and CAPA Management / Inspection Readiness:

  • Assist in the maintenance of the deviation and Corrective and Preventive Actions (CAPA) processes; manage the tracking of responses and the verification of CAPA commitments
  • Ensure close collaboration with the PDQ Inspections Group, and provide support for DHP products included as part of a trial

DHP Team Support:

  • Maintain awareness of the global, cross functional process landscape
  • Serve as DHP’s point of contact to the PDQ, Roche Diagnostics and other quality functions at the company
  • Create education materials to support the company’s knowledge concerning SaMD and appropriate documentation procedures 
  • Collaborate with DHP’s Platform Measurement Science group to develop a Data Integrity plan for Real-World Data (RWD) generated and collected through DHP software products
  • Support implementation and documentation of the scientific strategy for our DHP products, in close partnership with our other DHP groups, specifically Product Management and Architecture & Design
  • Review and feedback into the DHP validation plan
  • Identify opportunities and establish strategic partnerships with leading companies, academic institutions or working groups in the area of software quality

Software Quality Assessment:

  • Partner with DHP’s Architecture & Design function to develop a Software Quality Assurance process guide for DHP’s platform, along with an automated testing plan
  • Collaborate with all DHP functions to identify and prioritize features and processes that are in support of the platform’s continuous improvement
  • Assess and develop documentation strategy for each DHP product, this may include evaluation of internal QMS relative to vendor solutions in light of constraints (cost, resource, timelines)
  • Update the QMS and any related documentation to reflect changes and updates over the course of the lifecycle for DHP products
  • Support a multidisciplinary team in creating a model software stack that enables late stage development projects to simply implement design controls

Minimum Qualifications

  • Passionate about using technology and data-driven approaches to help improve the lives and health of our patients
  • Enthusiasm for Project Management principles, and 5+ years’ experience in a project/program management environment
  • Experience with GCP / GVP practices, as required in running clinical trials and auditing practices
  • Demonstrated experience delivering in an evolving environment, requiring proactivity and effective problem-solving and prioritization when faced with challenges
  • Familiarity with and past implementation of ISO25000, ISO/IEC/IEE 12207, and ISO12207 / aspects of quality and organizational excellence (CQOE)
  • An entrepreneurial mindset, tolerance for ambiguity, and a predilection for self-direction
  • Track record of effectively working in a matrix environment with global team members coming from scientific, business and technology backgrounds; skilled at influencing without authority
  • Customer-centric behavior, with experience in employing design-thinking
  • Excellent written and spoken communication in English
  • Undergraduate degree in Quality Assurance, Quality Control, Industrial Engineering, or a related field
  • Ability to travel internationally up to 20% time

Preferred Qualifications

  • Master’s degree in public policy, public health, engineering, or a scientific field
  • 5+ years’ experience in the pharmaceutical or medical device industry
  • Experience in working with the Center for Devices and Radiological Health / FDA, EU Health Authority or Notified Body
  • Experience with regulated medical devices and/or Software as a Medical Device (SaMD)
  • Experience in conducting internal compliance assessments and experience
  • Familiarity with Aha! roadmap and JIRA ticketing systems

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Roche is an equal opportunity employer.

Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs