The PositionAs an IT Quality Specialist at the SE6 level, you are part of a global project team responsible for developing, validating and implementing innovative software solutions for patients and COTS computerized systems in Roche’s Diagnostic division.
The Opportunity:
Job Responsibilities:
- Scope / (Content Leadership): Coordinate and advise on all validation activities on a global/organizational level for each assigned system/project. Author and review various validation documentation and deliverables depending on project delivery methodology (Waterfall, Agile, or Hybrid). Act as a CSV subject matter expert on project teams and support system audit inspection readiness. Lead and author Computerized System Periodic Reviews according to Roche policies and procedures.
- Accountability/Problem Solving: Ability to “think outside the box” while maintaining Quality Standards (lean and innovative mindset required).Assess changes to determine potential impact to the validated state of the computerized system. Review and collect expected CSV deliverables, records and other evidence according to plans.
- Stakeholder Management: Liaise with Business Quality and/or Informatics Quality to ensure regulatory compliance and compliance with corporate quality policies and standards. Interacts within and across multiple product squads within a domain, facilitating workshops and resolving conflicts to ensure alignment. Proactively shapes stakeholder perspectives, anticipates and strategically manages expectations in complex projects, and builds reliance through deep business understanding to act as a trusted advisor.
- Impact/Strategy:Demonstrates strong and consistent performance across diverse products, with impact typically extending to a specific product, initiative, or cluster. Contributes to the achievement of a product initiative and potentially domain goals by ensuring that delivered solutions meet business needs and provide demonstrable value.
- Complexity/ (Product Size):Manages validation and quality activities on more complex projects or across multiple products within a domain. Handles ambiguous requirements and evaluates solution impacts considering both immediate and longer-term implications within the domain. Ensures alignment with broader goals, manages interdependencies between related processes, and navigates intricate stakeholder environments.
- Business/Technical ability: Demonstrates a strong understanding of the business domain, related technologies, and their interdependencies. Can independently apply tools, principles, concepts, and techniques related to requirements, data, usability, and process analysis. Effectively handles interdependencies, managing the interconnections between various processes to improve overall efficiency and effectiveness.
Who you are:
(Education / Experience)
- 6+ years experience in Computer System Validation (CSV) implementing and supporting both COTS computerized systems and custom developed software applications, preferably in a GxP environment, or similar background.
- Validation specialist with experience in authoring and reviewing various validation documents and deliverables (Validation Plan/Report, Test Plan/Report, User Requirements, Functional Requirements, System & Functional Risk Assessments, System Acceptance Test Cases, User Acceptance Test Cases, Traceability Matrix).
- Bachelor’s degree in science/engineering/computer science and/or relevant work experience in a regulated industry
- Good understanding of FDA/EU GxP regulations and 21 CFR Part 11 ERES regulations
- Sound knowledge of various other computer system validation regulations / guidance documents (PIC/S, EU Annex 11, GAMP 5, TIR045) and data integrity principles (GAMP, MHRA, FDA)
Technical Skills
- Experience with different testing types (exploratory, regression, positive, negative, boundary, unscripted)
- Ability to make sound decisions for system validation and overall quality management relative matters
- Experience in authoring and reviewing various documents and deliverables (Validation Plan/Report, Test Plan/Report, User Requirements, Functional Requirements, System & Functional Risk Assessments, System Acceptance Test Cases, User Acceptance Test Cases, Traceability Matrix).
- Strong capability to independently apply tools, principles, concepts, and techniques related to requirements, data, usability, and process analysis.
- Ability to evaluate solution impacts (both immediate and long-term) and analyze technology fit for effective solutions.
Additional Qualifications
- Excellent verbal and written English communication skills
- Experience working with global project teams across multiple time zones
- Knowledge of software development lifecycle (SDLC) and Agile software development methodologies (Scrum and/or SAFe)
- Understanding of the Product Development Process (PDP) for Medical Devices is preferred
- Ability to work collaborative in cross-functional teams to achieve milestones and goals
- Ability to champion accountability by example, drive process improvement initiatives, and mentor junior team members.
Must be willing to work onsite in Pleasanton
Relocation benefits are not available for this positon.
The expected salary range for this position based on the primary location of California is $94,400-$175,200 of hiring range. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
