Senior Quality Specialist for Product Development,
Digital Health Technologies
WHO WE ARE:
The Digital Health Technologies (DHT) 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 with regulatory, quality, and privacy requirements. Our platform and services support advanced analysis of data captured and transmitted from apps, tools, Software as Medical Device (SaMDs), connected medical devices, and combination products.
DHT partners across the company to advance digital health solutions which include hardware, software, applications, tools, and platforms 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, design, conduct, and analysis of research use only and validated products
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 Compliance and Strategy (C&S) group within DHT 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 the product development is key. Scaling from prototypes to commercial in-market deployment and making effective use of generated data are priorities. C&S 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 DHT 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 Product Development Specialist in Digital Health Technologies will spearhead the quality strategy for a robust, replicable and scalable platform that will host clinically validated software. The Senior Quality Product Development 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 DHT product, in partnership with the Legal Manufacturer. The ideal candidate will be: well-versed in the implementation of design controls for clinically validate software; skilled at taking a methodical approach to the design, development and validation of a software product's QMS; and enthusiastic to streamline processes through innovation and the implementation of agile methodologies.
Product development and Software Quality
Lead quality and compliance activities for DHT's software products, including risk management plan development (RMPs), input into product design history file (DHF), design control procedures, and development/maintenance of the product's QMS
Strong communication skills and ability to partner with the diverse backgrounds in DHT's Architecture & Design function to develop a Software Quality Assurance process guide for DHT's software platform, along with an automated testing plan
Collaborate with all DHT functions to identify and prioritize features and processes that are in support of the platform's continuous improvement
Input and feedback into health authority submissions and discussions for DHT products
Support a multidisciplinary team in creating a model software stack that enables late stage development projects to simply implement design controls
Collaborate with DHT's Platform Measurement Science group to develop a Data Integrity plan for Real-World Data (RWD) generated and collected through DHT software products
Product Quality Management System (QMS) support
Assess the QMS needs for products in the DHT pipeline, and collaborate with stakeholders to enable early alignment of digital products with design controls
Partner with internal stakeholders to develop a QMS for the DHT platform/software stack, and to align modifications to the QMS with the platform product roadmap
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
Assess and develop documentation strategy for each DHT product, this may include evaluation of internal QMS relative to vendor solutions in light of constraints (cost, resource, timelines)
Ensure that all process documents that describe the QMS are properly maintained
Ensure that all processes are aligned with global Roche SOPs and any local requirements
Familiarity with ISO25000, ISO/IEC/IEE 12207, and ISO12207 / aspects of CQOE
Ensure this is done in compliance with the Roche Global Records Management Directive, in collaboration with the respective CoreMap Records Coordinator
Update the QMS and any related documentation to reflect changes and updates over the course of the lifecycle for DHT products
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 DHT products included as part of a trial
DHT Compliance Support
Maintain awareness of the global, cross functional process landscape
Support implementation and documentation of the scientific strategy for our DHT products, in close partnership with our other DHT groups, specifically Product Management and Architecture & Design
Support regulatory documentation and submission activities (e.g. FDA and EMA) for our DHT products, in partnership with relevant functions from across Roche
Support LQR in liaising with Functions to ensure compliant Vendor Management processes are in place, and that there exists effective vendor oversight
Create, audit and support plans for partnerships with legal manufacturers external to Roche/Genentech
Demonstrated experience delivering in an evolving environment, requiring proactivity and effective problem-solving and prioritization when faced with challenges
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 up to 20% time
Master's degree in public policy, public health, engineering, or a scientific field
5+ years' experience in product development
Experience in working with the Center for Devices and Radiological Health (CDRH) / FDA
Experience with regulated medical devices and/or Software as a Medical Device (SaMD), the 510k/PMA processes, and pre IDE/submission meetings
Experience with Good Clinical Practices and Good Pharmacovigilance practices as required in running clinical trials and auditing practices
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Roche is an equal opportunity employer.
Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs
Hoffmann-La Roche Ltd