Quality Functional Partner

Roche

. Lead the Q&R hub to align shared priorities and address quality issues and compliance gaps .

Posted 10/6/2026full-timeUnited StatesMid-LevelSenior💰 $103,900 - $221,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality management and regulatory compliance, with a strong focus on international laws such as IVDR, QSReg, and ISO 13485. Proven ability to lead cross-functional teams, drive data-based solutions, and foster an agile mindset within organizations.

Highest-signal resume keywords

Quality ManagementRegulatory ComplianceAgile MethodologiesStakeholder ManagementData-Driven Solutions

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ControlQuality AssuranceCAPA ActivitiesData AnalysisProblem SolvingProject ManagementRegulatory ExpertiseInternational LawsISO 13485IVDR

Soft Skills

LeadershipCommunicationInfluencingConflict ManagementCreativity

Industry Keywords

Diagnostic ProductsNMPAMDSAPLifecycle TeamsContinuous Improvement

About the role

Key responsibilities & impact

Lead the Q&R hub to align shared priorities and address quality issues and compliance gaps
Drive data-based action plans, propose solutions, and provide support and resolution
Communicate critical quality or regulatory issues and risks for transparency and unified messaging
Initiate and lead squads for requests, topics, or projects from Lifecycle Teams or Customer Areas
Represent the Quality organization in Lifecycle Teams and partner to resolve quality issues
Serve as the main Quality point of contact in Lifecycle Teams, providing guidance and receiving quality-related requests
Collaborate with Quality Function Partners across Customer Areas to share lessons learned
Support strategic initiatives that shift focus from reactive to proactive quality and foster an agile mindset
Build and maintain partnerships across Networks, Chapters, and stakeholders
Align with design quality assurance to improve product quality at launch
Promote continuous improvement and drive solutions and decision-making
Lead and support audit and CAPA activities as applicable
Collaborate with Product Quality Leads to implement data-driven solutions
Coordinate with Network Leads on areas of concern, actions, and visibility
Model Agile behaviors and support the organization’s transformation to more Agile Ways of Working

Requirements

What you’ll need

Bachelor’s or Master’s degree with 7–10 years of experience in quality management, quality control, or a related business function, or a PhD with 5–10 years of experience
Deep knowledge of international laws and regulations for the development and manufacturing of diagnostic products, including IVDR, QSReg, ISO 13485, NMPA, and MDSAP
Thought leadership in quality and regulatory matters
Track record building and nurturing capabilities in quality and compliance knowledge, regulatory expertise, communication, and stakeholder management
Ability to lead with creativity and high self-awareness
Ability to build networks and inspire agile working
Skill in prioritizing resources and fostering positive partnerships through effective influencing and conflict management
Recognized expertise in a specialized area with broad knowledge of own function
Experience solving unique problems that impact the organization
Senior advisory experience to management and leadership of large/cross-functional teams, projects, or initiatives
Based in Indianapolis, Branchburg, Pleasanton, Santa Clara, Carlsbad, or Tucson
Ability to work in a hybrid/on-site role; remote work arrangements are not available

Benefits

Comp & perks

A discretionary annual bonus may be available based on individual and Company performance
Benefits detailed at the link provided below
Relocation benefits are not available for this position