Title: Supplier Quality Assurance Supervisor

Overtime Status:Exempt

Employment Status:Full-Time

Pay Range: $93,500 to $130,000/yearly

The hiring pay range for this position is $93,500 to $130,000 per year based on skills, education, and experience relevant to this role.

Inventprise is a mission-driven bio-pharmaceutical company addressing global health inequalities by empowering people to live healthy lives. We do this by developing novel vaccines targeting infectious diseases for which there are no current preventive interventions or by optimizing currently marketed vaccines to provide a broader spectrum of protection, making them cheaper and more stable than before. We aspire to provide breakthrough public health interventions for all populations, globally. Inventprise is led by pioneers in vaccine discovery, seasoned experts in manufacturing and vaccine development, and proven commercialization veterans.

At Inventprise, we believe our people are our most valuable asset. We are strongly committed to a range of workplace programs that support the well-being, growth, and engagement of our employees and our business. What we offer:

Benefits:

Effective the first of the month following the date of hire, employees are eligible to participate in the following Inventprise employee benefit programs:

• Medical, Dental, Vision, FSA, or HSA: Currently Inventprise contributes 80% toward the Medical, Dental, and Vision coverage for the employee, and enrolled spouse and dependents. Medical plans are currently provided through Premera Blue Cross.
• 401(k) program: Inventprise contributes 3% of employee base pay each pay period to their 401(k) account. Employee contributions are at the discretion of the employee.
• Paid Time Off: Employees start PTO accruals at the rate of 5.83 hours each pay period - annualized equivalent of 140 hours/year.
• Paid Holidays: Inventprise offers 7 paid holidays each year: New Year's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, Day after Thanksgiving Day, and Christmas Day.
• Stock & Bonus Plans: Employees are eligible to participate in the Company’s Bonus and Stock Award Plans.

Summary:

• Manages and effectuates all Inventprise supplier evaluation and qualification activities for GMP related 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.
• Maintains the Inventprise Approved Supplier List (ASL) in accordance with procedure.
• Supports Inventprise Regulatory / Clinical programming 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 (IVT-SOP-ADM-001, et. al.).
• 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 ensure 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 tracking and trending as part of the IVT Quality Metrics / Trending SOP. Further, subject metrics will be analyzed with appropriate recommendations to Inventprise management.

Essential Functions:

• Supports the Director, Incoming QC / Microbiology, 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 Paradigm )or comparable 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 (or comparable) ERP platform, used for receipt, storage and quality dispositioning of GMP-related materials.

Non-Essential Functions:

• Ability to effectively deploy and maintain the supplier quality program using superior oral and written communication skills.
• Performs responsibilities in accordance with project timelines, departmental goals, and budgets approved by management.

Job Specifications:

• Proficient in MS Office Suite
• Knowledgeable with regard to applicable regulatory requirements for supplier quality. 
• Experienced in supplier auditing and communications / project management with external parties.

Education:

A B.Sc. degree in a scientific discipline required.

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.

Environmental Conditions:

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

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.