Senior Director, Product Quality & Strategy

Innoviva Specialty Therapeutics, Inc.; Waltham (MA); On-site; USD 170,000 - 260,000; Full time

Job summary

Innoviva Specialty Therapeutics, Inc. seeks a Director, Product Quality Lead to provide strategic quality leadership across a portfolio of commercial and late‑stage products.

This role reports to the Executive Director, External QA and drives end‑to‑end quality strategy, GMP compliance, inspection readiness, and uninterrupted product supply throughout the lifecycle. You will lead cross‑functional teams, manage complex quality risks across vendors and programs, and support regulatory submissions

Qualifications

• Minimum B.S. in a scientific or related field is required.
• 10+ years in Pharma/Biotech with 7+ years in QA within GMP environments.
• Experience leading quality oversight for small-molecule products across lifecycle.
• Strong capability to influence cross-functional teams and vendors.
• Experience supporting regulatory submissions and inspection readiness is desirable.

Responsibilities

• Provide strategic quality leadership across a portfolio from development through lifecycle.
• Define and execute product-specific quality strategies and risk mitigation.
• Establish governance with CDMOs and vendors to ensure GMP compliance and supply continuity.
• Lead investigation and CAPA processes for high-risk quality issues with vendors.
• Review documentation and support regulatory submissions and inspections.
• Travel domestically and internationally to vendor sites as needed.

Skills

Quality leadership

GMP compliance

Cross-functional leadership

Regulatory experience

Vendor management

Risk management

Education

B.S. in scientific field

Tools

Excel

Word

PowerPoint

Job description

Innoviva Specialty Therapeutics, Inc. seeks a Director, Product Quality Lead to provide strategic quality leadership across a portfolio of commercial and late‑stage products.

This role reports to the Executive Director, External QA and drives end‑to‑end quality strategy, GMP compliance, inspection readiness, and uninterrupted product supply throughout the lifecycle. You will lead cross‑functional teams, manage complex quality risks across vendors and programs, and support regulatory submissions