VP Quality & Regulatory - CDMO

Posted 31 May 2023
Salary Competitive
LocationUnited States of America
Job type Full Time
Contact NameChristopher Gomez

Job description

Mantell Associates is partnered with a very exciting CDMO. They are looking to take the company to new heights and grow at a rapid rate. One of the best working environments and culture in the industry. They are looking to bring in a VP Quality and Regulatory reporting to the CCO with 120 reports and 7 direct reports.

VP Quality and Regulatory - Responsibilities:

  • Provide leadership and oversight to the Quality Assurance, Quality Systems and Compliance, Laboratory Services, Continuous Improvement, and Regulatory Affairs teams, including hiring, managing, motivating, coaching and mentoring

  • Define and oversee implementation and maintenance of the Quality Management System

  • Participate as a core member of the Operations Leadership Team, which is responsible for operational oversight of all operations

  • Participate as a core member of the Executive Team, providing strategic guidance related to quality within the overall organization

  • Ensure that all regulatory compliance documents are prepared in accordance with regulatory guidelines, internal standards and SOPs

VP Quality and Regulatory - Requirements:

  • 15 years of industry experience within pharma, biopharma and/or biotech companies

  • Direct experience interacting with FDA and other regulatory authorities

  • Leadership experience with direct reports and indirect reports

  • Someone that can be a voice and mange up and down

  • Experience working in a CDMO is ideal

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact Christopher Gomez 786-245-8592 or Christopher.gomez@mantellassociates.com.