Supplier QA Program Manager

About Inventprise

At Inventprise, developing innovative and widely available vaccines is in our DNA. By producing targeted vaccines for populations worldwide, we're addressing global health inequalities and empowering people to live healthy lives—no matter where they live. Headquartered in Redmond, WA, our goal is to deliver affordable, effective vaccines at large scale to Low and Middle-Income Countries, as well as populations in the U.S. and around the world. Inventprise is committed to creating a diverse and inclusive workplace, where our people are inspired to do their best work. We’re proud to have some of the world’s most qualified industry scientists, researchers, and manufacturing professionals on our team, and strive to create a vibrant, dynamic presence in the Washington State Life Sciences environment.

What the Role Offers - Supplier QA Program Manager

The Supplier QA Program Manager is responsible for overseeing supplier evaluation and qualification for GMP materials and services, maintaining the Approved Supplier List and ensuring adherence to supplier quality and purchasing programs. This role supports the biomanufacturing processes, clinical trial activities, internal and external audits, manages quality agreements with suppliers and vendors, leads applicable non-conformance investigations, coordinates material specification approvals and tracks supplier performance metrics, collaborating closely with incoming quality control teams and maintains all supplier data within the QMS platform.

What You Need to Succeed

• Manages and drives all Inventprise supplier evaluation and qualification activities for GMP-related incoming materials and services in accordance with Inventprise procedures (including but not limited to auditing, approval, disapproval, and collaborative interface with CMOs / suppliers as relates to their qualification status).
• Lead internal audits in accordance with company procedures and applicable regulatory requirements.
• Maintains the Inventprise Approved Supplier List (ASL) in accordance with procedure.
  
• Supports Inventprise Regulatory / Clinical activities as relates to qualifying Clinical Research Organizations and related laboratories/service providers, associated with the clinical phase of the product life cycle.
• Verifies that responsible Inventprise personnel and Purchasing are adhering to the requirements of the supplier quality program, as well as the Purchasing program. 
  
• Supports and coordinates the development and approval of material specifications for GMP-related materials intended for Phase 3 clinical or commercial use.
• Participates in and ensures timely and effective non-conformance / complaint investigations for issues assignable to material/service providers.
• Assures formal Quality Agreements between IVT and respective suppliers are in place and current, in accordance with approved procedures.
• Posts Quality Metrics, including, but not limited to, overall supplier quality, performance tracking and trending as part of the IVT Quality Metrics / Trending SOP. Further, subject metrics will be analyzed with appropriate recommendations to Inventprise management.
• Supports the Vice President of Quality in collaborating with Incoming Quality Control personnel who are responsible for testing and releasing GMP-related incoming materials.
• Establishes and maintains supplier-related data in the QMS platform including but not limited to:
  
  • Respective supplier correspondence.
  • ASL.
    
  • Onsite supplier audits/responses.
  • Quality Questionnaires.
    
  • Supplier quality metrics reports.
• Establishes supplemental program training materials and (together with existing related procedures) conducts on-the-job training (OJT) of responsible Inventprise personnel.
• Routinely collaborates with Warehouse management to ensure that quality criteria defined by the supplier program, are effectively met in the use of NetSuite ERP platform, used for receipt and storage of GMP-related materials.

Required Qualifications:

Educational Pre-requisites:

• Bachelor’s degree in a scientific discipline (Biology, Chemistry, Biochemistry, Microbiology, etc).
• Knowledge of Good Manufacturing Practices as described in 21CFR 210-211 and their clinical stage dependent application to FDA, EMA, USP, WHO, PIC/S and other relevant global regulatory agencies.
• Minimum of 8 years of experience in Quality Assurance (QA) and supplier management within a regulated environment.

Physical Demands:

• Standard standing, sitting, and lifting associated with light-office work is required.
• No requirements to lift any items over 20 lbs.
• Working at a computer for long periods of time is required.
• Must be able to travel up to 20% of the time.

Mental Demands:

• Ability to manage time effectively to coordinate multiple projects simultaneously required.
• Ability to use problem solving techniques to ensure project goals are met.
• Effective communication skills both verbally and written are necessary to communicate within the department and with external clients.

Working Conditions:

• Primarily this position involves working in an office environment.
• Occasional work in a temperature controlled warehouse may be required.
  
• Proficient in MS Office Suite.
  

Estimated Base Salary: 

• $89,000 - $96,000 Yearly DOE
• It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case.
• The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location.

Benefits:

• Medical, Dental, Vision, FSA, or HSA: Inventprise contributes 80% toward the Medical, Dental, and Vision coverage for the employee, and their enrolled spouse, and dependents. Medical plans are currently provided through Premera Blue Cross.
• 401(k) program: Inventprise offers both pre-tax 401(k) and post-tax Roth retirement savings plans, letting you decide how you want to save for the future. We also make an employer contribution of 3% of your total earnings each pay period, regardless of whether you contribute.
• Paid Time Off: Generous PTO, in addition to paid holidays.
• Stock & Bonus Plans: Employees are eligible to participate in the Company’s Bonus and Stock plans.

Our People-First Philosophy

At Inventprise, you’ll be part of a world-class team working on innovative vaccines and technologies that have global impact. Our people are an integral part of our strategy, allowing us to grow as a company and improve our performance year-over-year.
Our company was built on the belief that by working together, we have the ability to make the world a better place and improve lives. We have a growth mindset and are constantly looking for ways to enhance our contributions to improve global health. We believe that when we support each other and set high standards, we are able to do our best work.

Equal Opportunity Employer

Inventprise is an equal-opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender, identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.