Careers

Aevi Genomic Medicine, Inc. is dedicated to translating genetic discoveries into novel therapies. Driven by a commitment to patients, and guided by genomic insights, we strive to help patients navigate through the complexities of their disease. If you are looking for an opportunity to be part of building a fast-paced, collaborative, scientifically-disciplined team, then this is a great time to join Aevi to make a difference in the lives of children and adults with pediatric-onset diseases.

Job Openings >> VP, Head of Quality Assurance and Quality Control
VP, Head of Quality Assurance and Quality Control
Summary
Title:VP, Head of Quality Assurance and Quality Control
ID:1019
Department:Executive
Description

VP, Head of Quality Assurance and Quality Control

The Vice President, Head of Quality Assurance and Quality Control manages the total compliance function for Aevi. This includes ensuring compliance with established company quality policies, practices, standard operating procedures (SOPs) and federal regulations.

  • This role is responsible for designing, implementing and maintaining (GxP) QA and QC programs, and the compliance infrastructure. This includes the SOP system, training programs, and performing internal and external audits.
  • Lead and manage inspections by FDA, other regulatory agencies and company’s commercial partners.
  • Coordinate with regulatory agencies and other external auditors to build trust and confidence in Aevi’s quality systems.
  • Lead quality input on contracts and serve as the primary contact for the negotiation of quality agreements.
  • Work with the company’s external suppliers including Clinical Research Organizations (CROs) and contract labs to ensure consistent quality and compliance.
  • Direct development and implementation of quality systems to ensure product reliability, quality, efficacy, compliance to applicable SOPs, GXP regulations.
  • Oversee compliance (GMP and GCP) auditing program to fulfill regulatory requirements.
  • Develop, manage and monitor adherence to the overall Quality and Compliance budget.
  • Develop, analyze and report business metrics and highlights.

      Requirements:

  • Bachelor’s Degree in Science or a related field (Advanced degree preferred) with 15 years of experience in the pharmaceutical or biotechnology industry in a quality or compliance, with at least 2 years as a functional head
  • Strong GxP knowledge in the pharmaceutical industry
  • Hands-on experience with implementing and managing Quality/Compliance systems and processes (infrastructure)
  • Proven record of developing and maintaining successful working relationships with regulatory agencies

 

Powered by ApplicantStack

Aevi Genomic Medicine, Inc. offers its employees a competitive benefits and compensation plan.

Aevi Genomic Medicine, Inc. is an Equal Opportunity Employer.