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.firstname.lastname@example.org.