Quality & Lifecycle Lead — Agile Q&R Partner

Regulatory Jobs; Indianapolis (IN); Hybrid; USD 104,000 - 222,000; Full time

Job summary

Roche in Indiana offers a hybrid/on-site Quality Functional Partner role, leading the Q&R hub and representing Quality in Lifecycle Teams. You will drive data-driven quality strategies, collaborate across networks, and advance proactive quality initiatives.

The position requires deep regulatory knowledge (IVDR, QSReg, ISO 13485) and strong leadership of cross-functional teams, audits, CAPA, and continuous improvement efforts. Relocation not offered.

Qualifications

• Bachelor's or Master's degree with 7-10 years in quality management or similar, or PhD with 5-10 years.
• Deep knowledge of international regulations for diagnostics (IVDR, QSReg, ISO 13485, MDSAP).
• Proven leadership in quality/regulatory matters and stakeholder management.
• Strong communication and ability to build and nurture cross-functional capabilities.
• Senior advisory experience to management on large cross-functional programs.

Responsibilities

• Lead the Q&R hub to align on priorities and address quality issues and compliance gaps.
• Represent Quality in Lifecycle Teams and coordinate with Network Leads.
• Drive proactive quality strategies and agile mindset across the organization.
• Oversee audits and CAPA activities with Product Quality Leads.
• Collaborate to break down silos and improve cross-network collaboration.

Skills

Quality management

Regulatory expertise

Stakeholder management

Agile mindset

Education

Bachelor/Master degree

PhD

Job description

Roche in Indiana offers a hybrid/on-site Quality Functional Partner role, leading the Q&R hub and representing Quality in Lifecycle Teams. You will drive data-driven quality strategies, collaborate across networks, and advance proactive quality initiatives.

The position requires deep regulatory knowledge (IVDR, QSReg, ISO 13485) and strong leadership of cross-functional teams, audits, CAPA, and continuous improvement efforts. Relocation not offered.