Strategic Quality Partner

Strategic Quality Partner (SQP)

The Strategic Quality Partner (SQP) acts as a single point of contact within project teams (New Product Development / Product Change) for a portfolio of products assigned to them, ensuring consistent interpretation and implementation of global requirements across customer areas.

• Lead and drive decisions for strategic topics from a compliance and product quality perspective.
• Partner with internal and external stakeholders across the value chain to accelerate the development process and incorporate learnings.
• 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 (e.g., at project team meetings).
• Drive awareness and adoption of the Risk Enabler inside and outside 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.

• Bachelor’s degree in science, engineering, business administration or a related field.
• MBA or advanced degree is considered an advantage.
• 8+ years of experience in the diagnostics industry or a related business function.
• Strong scientific and technical background with sound product knowledge, ideally with assay/reagents/system/hardware/software development experience for IVD products.
• Strong business and financial acumen with an enterprise mindset.
• Knowledge of regulations pertaining to the environment (ISO
  13485, ISO
  14971, GDP, GMP, others).
• Excellent communication, presentation, and negotiation skills.
• Strong agile knowledge and capabilities demonstrating new ways of working.
• Pragmatic decision making and ability to move forward without a perfect solution.
• Demonstrated thorough end-to-end understanding of lifecycle management.
• Strong leadership capabilities, with experience in leading cross‑functional teams (e.g., Squad Lead, Matrix Lead) and driving change.

Location:

Tucson, Arizona – primarily onsite. Relocation benefits are not available for this position.

Expected salary range: $103,800 – $221,780, based on experience and qualifications. A discretionary annual bonus may be available and the position qualifies for company benefits.

This position also qualifies for the benefits detailed at the company benefits page.

Roche is an equal‑opportunity employer. The company’s policy prohibits unlawful discrimination, including but not limited to discrimination on the basis of veteran status, individuals with disability status, and is consistent with all federal, state, and local laws.