Genentech
South San Francisco, CAThe PositionWHO 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 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 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 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 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 productAssess the QMS needs for products in the DHP pipeline, and collaborate with stakeholder to enable early alignment of digital products with design controlsPartner with DHPs Product Management and Architecture & Design groups to identify tools and processes for streamlined product compliance with quality managementUnderstand 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 progressWork with departments to collect and compile data for quarterly reports for global and Roche Affiliate Management ReviewSupport LQR in liaising with Functions to ensure compliant Vendor Management processes are in place, and that there exists effective vendor oversightEnsure that all processes are aligned with global Roche SOPs and any local requirementsEnsure this is done in compliance with the Roche Global Records Management Directive, in collaboration with the respective CoreMap Records CoordinatorDeviation 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 commitmentsEnsure close collaboration with the PDQ Inspections Group, and provide support for DHP products included as part of a trialDHP Team Support:Maintain awareness of the global, cross functional process landscapeServe as DHPs point of contact to the PDQ, Roche Diagnostics and other quality functions at the companyCreate education materials to support the companys knowledge concerning SaMD and appropriate documentation procedures Collaborate with DHPs Platform Measurement Science group to develop a Data Integrity plan for Real-World Data (RWD) generated and collected through DHP software productsSupport implementation and documentation of the scientific strategy for our DHP products, in close partnership with our other DHP groups, specifically Product Management and Architecture & DesignReview and feedback into the DHP validation planIdentify opportunities and establish strategic partnerships with leading companies, academic institutions or working groups in the area of software qualitySoftware Quality Assessment:Partner with DHPs Architecture & Design function to develop a Software Quality Assurance process guide for DHPs platform, along with an automated testing planCollaborate with all DHP functions to identify and prioritize features and processes that are in support of the platforms continuous improvementAssess 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 productsSupport a multidisciplinary team in creating a model software stack that enables late stage development projects to simply implement design controlsMinimum QualificationsPassionate about using technology and data-driven approaches to help improve the lives and health of our patientsEnthusiasm for Project Management principles, and 5+ years experience in a project/program management environmentExperience with GCP / GVP practices, as required in running clinical trials and auditing practicesDemonstrated experience delivering in an evolving environment, requiring proactivity and effective problem-solving and prioritization when faced with challengesFamiliarity 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-directionTrack record of effectively working in a matrix environment with global team members coming from scientific, business and technology backgrounds; skilled at influencing without authorityCustomer-centric behavior, with experience in employing design-thinkingExcellent written and spoken communication in EnglishUndergraduate degree in Quality Assurance, Quality Control, Industrial Engineering, or a related fieldAbility to travel internationally up to 20% timePreferred QualificationsMasters degree in public policy, public health, engineering, or a scientific field5+ years experience in the pharmaceutical or medical device industryExperience in working with the Center for Devices and Radiological Health / FDA, EU Health Authority or Notified BodyExperience with regulated medical devices and/or Software as a Medical Device (SaMD)Experience in conducting internal compliance assessments and experienceFamiliarity with Aha! roadmap and JIRA ticketing systems#ds#LI-HB2#PDPWho We AreA 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 Regular
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