Job Description:

Title: QA Supplier Quality ManagerReport: Head of Quality AssuranceLocation: Philadelphia, PA Position Type: Full Time, ExemptTravel: 25%Find out exactly what skills, experience, and qualifications you will need to succeed in this role before applying below.Company SummaryVintaBio is a technology company focused on simplifying AAV and lentivirus production. Our custom research and development approach is designed to integrate into services, including platform bridging, GLP toxicology material, and GMP manufacturing. Our research core produces high-yield and world-class POC vectors. Through a comprehensive production workflow that utilizes VintaBio's proprietary cell lines and transfection reagents, we expedite the path to the clinic, offer more reliable manufacturing, and improve economics.Position SummaryThe role of the QA Supplier Quality Manager is to develop and manage the supplier quality activities to support GMP operations and maintain compliance with health authority regulations and established standards.Key ResponsibilitiesTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.Develop, implement, manage, and oversee Vendor Management activities supporting VintaBio GMP operations.Conduct and manage vendor audits to ensure compliance to all relevant policies and procedures as required.Author vendor audit reportsPerform trend review and metric reporting for vendor non-conformance investigations.Manage Vendor Supplier Notifications.Collaborate with suppliers to drive resolutions to GMP material/service non-conformances identified.Review and approve vendor audit report responses and perform follow up activities in support of closure of vendor audit reports.Review and approve investigations/corrections performed by a supplier.Makes sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management.Participate and may lead Material Review Board forums.Represent quality team on cross-function meetings and improvement initiatives.Drives opportunities for continuous improvement through project leadership and group engagement.Assist in the preparation of regulatory and client audits.Ensures proper escalation and remediation of all critical issues. Participates in Site Quality Assessment processes.Performs other job functions as directed by the Head of QA.Education and ExperienceEducation: Bachelor's degree (or higher) in life sciences or related field.A minimum 10 years of directly relevant experience in a regulated environment with 7 years focused on product quality is required.Experience in quality management of suppliers that provide raw materials, consumables and services used in biotech bulk and finished product manufacturing is highly desirable.Experience with Process Development to commercial product manufacturing in biologics is preferred.CQA is preferred but not required.Knowledge, Skills and AbilitiesExtensive knowledge of US, EU cGMPs, ISO and ICH regulations and guidance's.Work experience where attention to detail and personal accountability were critical to success.Experience working in a team-based environment with a diverse group of people.Must have knowledge of supplier quality activities (performance of external audits, preparation, and negotiation of Quality Agreements.Demonstrates organizational and time management skills.Ability to manage multiple tasks simultaneously, meet deadlines, and adapt to changing requests.Excellent writing and oral communication skills are required.Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.Thrive in a fast-paced, innovative environment remaining flexible, proactive, resourceful, and efficient.Proficient in Microsoft Office products. Working knowledge of eQMS systems is preferred.VintaBio's BenefitsIn addition to good working conditions and competitive pay, it is VintaBio's policy to provide a comprehensive benefits package that provides access to plans which support the overall wellbeing of our employees and their dependents. These benefits include, but are not limited to, health care coverage (medical, dental, vision, pharmacy), a retirement plan that includes a 401K, Life Insurance options, Disability coverage, paid time-off, and more.VintaBio does not discriminate on the basis of actual or perceived race, religion, color, national origin, ancestry, disability, medical condition, marital status, sex, age, sexual orientation, gender identity or expression, family responsibility, personal appearance, genetic information, matriculation, political affiliation, or any other status protected under law.Other Physical Requirements: Must abide by safety requirements of site and off-site vendors. Work Environment Work is performed primarily in office. This is an onsite position.