Director, Product Quality Lead

Innoviva Specialty Therapeutics•Waltham, MA

22h

About The Position

The Director, Product Quality Lead (PQL) provides strategic quality leadership and end‑to‑end product ownership within the Quality department across a portfolio of commercial and late‑stage products. Reporting to the Executive Director, External QA, this role is accountable for defining and executing product quality strategy, ensuring sustained GMP compliance, inspection readiness, and uninterrupted product supply throughout the product lifecycle. The Director, Product Quality Lead serves as the senior Quality representative for assigned products, leading cross‑functional alignment and providing quality governance to internal stakeholders and external partners. This role requires deep expertise in small-molecule products, quality assurance, and regulatory expectations, as well as a demonstrated ability to lead cross-functional teams, influence decision‑making, and manage complex quality risks across multiple products and vendors.

Requirements

B.S. or B.A. degree in a scientific or relevant technical field required.
10 plus years of experience in the Pharmaceutical or Biotech industry, including 7 plus years in Quality Assurance roles within a GMP regulated environment.
Demonstrated experience supporting and leading quality oversight for small‑molecule products, across development, clinical, and commercial stages.
Proven experience providing product quality leadership across multiple products or programs, including lifecycle management and launch support.
Expert knowledge of U.S. and international GMP regulations and guidelines applicable to the development, validation, manufacture, testing, and release of small‑molecule drug substance and drug product.
Strong judgment and decision‑making skills, with the ability to evaluate complex quality issues and provide clear, defensible recommendations that balance compliance, risk, and business needs.
Proven ability to lead through influence, align cross‑functional stakeholders, and drive consensus in complex organizational and vendor environments.
Strong organizational and prioritization skills, with the ability to manage competing product demands and deliver results in a fast‑paced environment.
Demonstrated ability to operate independently at a strategic level while providing leadership, direction, and decision support across cross‑functional teams.
Excellent written and verbal communication skills, including the ability to communicate complex quality topics.
High level of professionalism, integrity, and accountability, with a demonstrated commitment to a quality culture and continuous improvement.
Proficiency with standard business and quality systems (e.g., document management systems, Excel, Word, PowerPoint), with the ability to translate data into actionable insights.
Ability to travel domestically and internationally to vendor and manufacturing sites as needed.

Nice To Haves

Experience supporting regulatory submissions, post‑approval commitments, and inspection readiness activities with the FDA and international health authorities is desirable.

Responsibilities

Provide strategic quality leadership and product ownership across a portfolio of commercial and late‑stage products, from development through commercial supply and lifecycle management.
Define and execute product‑specific quality strategies, including risk identification, mitigation, and prioritization across the product lifecycle.
Establish and maintain effective quality governance models with CDMOs, laboratories, and other external partners, including alignment with vendor senior leadership to ensure GMP compliance, performance, and supply continuity.
Lead the resolution of complex, high‑risk quality issues with vendors, including deviations, OOS/OOT events, investigations, CAPAs, and change controls.
Review master and executed batch documentation and ensure the compliant release of drug substance and drug product batches to support commercial supply activities, as well as any development and validation requirements.
Review and approve development and analytical protocols, reports, methods, data, and specifications.
Act as the Quality representative for post‑approval commitments and support regulatory submissions, responses, and inspections, as required.
Support or manage the supplier qualification program, including vendor qualification audits and associated documentation.
Ensure continuous inspection readiness across assigned products and vendors, including active participation in regulatory inspections and internal/external audits.
Author, review, and /or approve Policies, SOPs, forms, and templates in compliance with document control system requirements, as needed.
Ensure adherence to applicable regulations including FDA, EMA, ICH, GMP and IST policies and procedures.
Travel to vendor sites as needed.