Director of Quality Operations - CRO

Posted 06 April 2023
Salary Competitive
LocationUnited States of America
Job type Full Time
Discipline CRO & Clinical Operations
Contact NameChristopher Gomez

Job description

Mantell Associates is currently partnered with a global Industry leading CRDMO for a Director Of Quality Operations. We are seeking a highly motivated and experienced Director of Quality Operations to lead the Quality department for a Contract Development and Manufacturing Organization (CDMO). The Director of Quality Operations will be responsible for ensuring that the company's products and services meet the highest quality standards and comply with regulatory requirements.

Director of Quality Operations Responsibilities:

  • Provide leadership and strategic direction to the Quality department, including Quality Control, Quality Assurance, and Compliance functions.

  • Develop and implement quality systems, policies, procedures, and practices to ensure compliance with all applicable regulations and industry standards.

  • Manage the site quality organization to ensure compliance with applicable regulations, guidelines, and customer requirements.

  • Conduct risk assessments and develop risk mitigation strategies to minimize potential quality and compliance risks.

  • Manage customer audits and regulatory inspections and ensure that all non-conformances are identified, investigated, and resolved in a timely manner.

Director of Quality Operations Requirements:

  • Expertise in cGMP regulations, ICH guidelines, and regulatory requirements for drug development and manufacturing.

  • Strong leadership and management skills, with experience in building and leading teams.

  • Excellent communication, negotiation, and problem-solving skills.

  • Ability to work effectively with cross-functional teams and external partners.

  • Ability to prioritize and manage multiple projects simultaneously.

  • Experience working in a CDMO is preferred.

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