Director of Quality - Biologics

Posted 08 June 2024
Salary Negotiable
Job type Full Time
Discipline Large Molecule
Contact NameSiobhan Mcloughlin

Job description

Mantell Associates is currently working on an exciting opportunity for an experienced professional to lead as Director of Quality. Reporting directly to the Vice President, Quality, this role encompasses overseeing all quality-related efforts associated with the manufacturing and testing of pharmaceutical products. Your leadership and expertise will drive compliance with industry regulations and continuous improvement initiatives, shaping the future of quality operations.

Director of Quality - Responsibilities:

  • Set ambitious departmental goals and provide guidance to the Quality Unit team
  • Direct Quality Control, Quality Assurance, and Quality Projects teams to excellence
  • Ensure seamless product transfer processes, adhering to cGMP requirements
  • Design and review investigational plans for deviations, CAPAs, and laboratory investigations
  • Implement policies and initiatives to enhance professional capabilities and efficiencies
  • Coordinate and manage multiple projects, optimizing budgets and driving cost-saving measures
  • Develop, utilize, and report metrics for performance evaluation and goal setting
  • Maintain readiness for customer audits and regulatory inspections
  • Embrace Health and Safety Policy and tackle additional duties as assigned

Director of Quality - Requirements:

  • Bachelor of Science or equivalent experience in Analytical Chemistry, Biochemistry, or related discipline
  • Ten years of relevant industrial experience
  • Knowledge of cGMP, ICH, FDA guidelines, and pharmaceutical manufacturing processes
  • Demonstrated leadership and project management skills
  • Strong motivation, resourcefulness, and communication abilities
  • Proficiency in computer skills and organizational capabilities
  • Leadership Competencies:
  • Emotional intelligence
  • Leverage Diversity
  • Organizational Intelligence
  • Develop Others
  • Facilitate Transformation

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +1 (786) 485 1298.