Senior Quality Specialist for Product Development , Digital Health Technologies (PHC)

The Position 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 patients 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 POSITION: The Compliance and Strategy (C&S) group within DHT leads the teams 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 products QMS; and enthusiastic to streamline processes through innovation and the implementation of agile methodologies.

RESPONSIBILITIES: Product development and Software Quality Lead quality and compliance activities for DHTs software products, including risk management plan development (RMPs), input into product design history file (DHF), design control procedures, and development/maintenance of the products QMS Strong communication skills and ability to partner with the diverse backgrounds in DHTs Architecture & Design function to develop a Software Quality Assurance process guide for DHTs 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 platforms 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 DHTs 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 Vendor Management 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 Minimum Qualifications 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 Preferred Qualifications Masters 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 Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

For more information about equal employment opportunity, visit our Genentech Careers page.

PDP LI-HB2 ds Who We Are A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases.

Genentech has multiple therapies on the market for cancer & other serious illnesses.

Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours.

To apply today, click on the ”Apply online” button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

For more information about equal employment opportunity, visit our Genentech Careers page .

Job Facts JOB FUNCTION General Regulatory Affairs COMPANY/DIVISION Pharmaceuticals SCHEDULE Full time JOB TYPE RegularPandologic.

Keywords: Quality Control / Quality Assurance Specialist, Location: Pinole, CA
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