Diagnostics Quality Strategy Leader

Regulatory Jobs; Tucson (AZ); On-site; USD 104,000 - 222,000; Full time

Job summary

Roche in Tucson, Arizona seeks a Strategic Quality Partner to lead cross-functional teams on quality and regulatory challenges for NPD and updates. You will collaborate with Development Leads, Regulatory Affairs, Operations, and Post-Market Quality to streamline development and apply learnings.

The role requires 8+ years in diagnostics or related fields, strong regulatory knowledge (ISO 13485, IVDR), and proven leadership. It is primarily onsite with a competitive salary and discretionary bonus.

Qualifications

• Bachelor's degree in science, engineering, business administration or a related field.
• MBA or advanced degree is considered an advantage.
• Strong agile knowledge and capabilities demonstrating new ways of working.
• Excellent communication, presentation, and negotiation skills.

Responsibilities

• Ensure consistent interpretation & implementation of global requirements across Customer Areas (CAs).
• Incorporate lessons learned from all areas of quality into project support and ensure PostMarket Quality feedback is built into the requirements.
• Ensure development project plans contain the right deliverables according to the Design & Development module to deliver safe and compliant solutions.
• Support internal and external audits.
• Lead and facilitate constructive discussions at project team meetings.
• Drive awareness and adoption of the Risk Enabler inside and outside of Global Quality & Regulatory decision making; prepare and enable risk-based decisions.
• Partner to ensure effective resolution of issues (e.g. CAPA, NC).
• Ensure effective feedback loops and information flow for milestone review.

Skills

Agile knowledge

Communication

Leadership

Project management

Problem solving

Education

Bachelor's degree (science/engineering/business)

MBA or advanced degree

Job description

Roche in Tucson, Arizona seeks a Strategic Quality Partner to lead cross-functional teams on quality and regulatory challenges for NPD and updates. You will collaborate with Development Leads, Regulatory Affairs, Operations, and Post-Market Quality to streamline development and apply learnings.

The role requires 8+ years in diagnostics or related fields, strong regulatory knowledge (ISO 13485, IVDR), and proven leadership. It is primarily onsite with a competitive salary and discretionary bonus.