Associate Director, Product Quality Lead

Company Overview:

Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., is a biopharmaceutical company developing and delivering innovative therapies in critical care and infectious disease. Our approved treatments are indicated to address high unmet medical needs for serious conditions, and our investigational therapies are in development for patients fighting drug-resistant pathogens. Innoviva currently has three marketed medicines – GIAPREZA® (angiotensin II) for the treatment of refractory hypotension in adults with septic or other distributive shock , XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI), and XACDURO® (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex. Our investigational therapy, Zoliflodacin is a potential first-in-class, orally administered, single dose antibiotic with a novel mechanism of action that is currently in development for the treatment of uncomplicated gonorrhea. At Innoviva Specialty Therapeutics, Inc., we are building a culture dedicated to delivering products that address critical medical needs. If this is your passion, come and join us to make differences for patients.

Summary of Position:

The Associate Director, Product Quality Lead (PQL) works within the Quality department to support quality assurance, quality compliance, and daily operations. Reporting to the Senior Director, GMP QA, the Associate Director, Product Quality Lead will execute against quality programs and documentation to assure compliance in a GMP regulatory environment. This role requires a strong background in small molecule products, quality assurance, and regulatory affairs, as well as proven experience in coordination and execution of cross-functional activities. The role involves developing, approving, monitoring, and maintaining critical quality standards to proactively minimize product quality risks. The individual will work closely with the Chemistry Manufacturing and Controls (CMC) Team and contract manufacturers to ensure support of GMP manufacturing and analytical activities, as well as provide quality and compliance guidance. The individual will serve as the product quality/project lead for existing products and for the introduction of new products and support all activities required for launch.

Responsibilities:

• Act as Product Quality/Project Lead for products including the onboarding of new products and provide quality oversight and guidance throughout the CMC lifecycle management.
• Act as the Quality representative for Post Approval Commitments and in the generation of regulatory submission documents.
• Lead product programs from the Quality Assurance perspective and be the key Quality Assurance contact.
• Collaborate with CMC and contract manufacturers to evaluate and address complex issues such as Deviations, Out of Specification (OOS) events, Corrective and Preventive Actions (CAPA), Change Control, and failure investigations.
• Review of master and executed batch documentation and assurance of compliant release of drug substance and drug product batches to support commercial supply activities and any development and validation requirements.
• Review and approval of development and analytical protocols, reports, methods, data, and specifications.

• Support or manage the supplier qualification program, including vendor qualification and vendor audits and/or documentation.
• 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 Entasis policies and procedures.
• Actively participate in inspection activities, as needed, as well as in internal and external GMP audits.
• Must be able to travel to vendor sites as needed.

Experience & Education:

• B.S. or B.A. Degree in a scientific field or relevant technical field required.
• Scientific analytical background required.
• 5 plus years of experience in Biotech or Pharmaceutical industry including 3 years in a Quality Assurance role.
• Direct experience working with and/or supporting cGMP manufacturing activities and/or CMC.

Skills and Abilities:

• Knowledge of US and International GMP guidelines for Qualification, Manufacturing and Testing of API and Drug Product
• Solid and demonstrable knowledge of GMP regulations, guidelines, quality principles, industry practices, and standards.
• Attention to detail with an ability to perform critical review of pharmaceutical development, manufacturing, and analytical documentation.
• Shows strong initiative and independence, including work as a team player. Able to perform routine work, solve problems, and fulfill responsibilities with little or no additional instruction.
• Ability to multi-task, as position requires executing multiple projects simultaneously.
• Experience working with CMOs, vendors, and relationship management preferred.

• Excellent written and oral communication skills, including report writing.
• Strong computer skills (Excel, Word, PowerPoint, Project) and solid presentation skills.

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.