Director, Product Quality Lead

Company Overview:

Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., is a biopharmaceutical company focused on developing innovative solutions for patients and healthcare providers in the fields of Critical Care and Infectious Diseases.

Our mission to deliver innovative, life-saving medicines for serious unmet medical conditions drives us every day and contributes to building a sustainable business for the long term. It also inspires our entrepreneurial culture which fosters innovation, collaboration, and a relentless commitment to the people we serve. Patients are at the center of everything we do because everyday matters. Every employee is encouraged to take initiative, explore new ideas, and turn challenges into opportunities that can potentially transform lives, especially those suffering from serious and difficult-to-treat illnesses.

Our products marketed in the U.S. include:

• GIAPREZA® (angiotensin II) is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock.
• XACDURO® (sulbactam for injection; durlobactam for injection) is a new treatment designed specifically to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex in adults.
• XERAVA® (eravacycline) is a broad-spectrum antibiotic used to treat patients with complicated intra-abdominal infections (cIAI).
• ZEVTERA® (ceftobiprole) is a newly approved advanced-generation cephalosporin antibiotic and the only FDA-approved cephalosporin specifically designed to treat adult patients with Staphylococcus aureus bloodstream infections (bacteremia) including those with right-sided infective endocarditis. In addition, Zevtera is approved in adult patients with acute bacterial skin and skin structure infections (ABSSSI), and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).
• Nuzolvence® (zoliflodacin) for oral suspension is a first-in-class, single-dose oral antibiotic for the treatment of uncomplicated urogenital gonorrhea in adults and adolescents 12 years of age and older weighing at least 35 kg.
  
  
  

Summary of 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

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.
  
  
  

Experience & Education:

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

Skills and Abilities:

• 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.
  
  
  

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Innoviva Specialty Therapeutics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Please Note: Innoviva Specialty Therapeutics does not accept unsolicited resumes or candidate submissions from staffing agencies or recruiters. Any such submissions will be considered property of Innoviva Specialty Therapeutics, and we will not be obligated to pay any fees associated with them unless a prior written agreement is in place.