Quality Director - CDMO

Posted 10 April 2024
Salary Negotiable
Job type Full Time
Discipline Large Molecule
Contact Name Huseyin Pulat

Job description

Mantell Associates are partnered with a leading CDMOorganisation in their search for a Director of Quality to join their senior leadership team and build, lead and execute a quality strategy.

Director of Quality - Responsibilities:

  • Management responsibility for the quality unit, training, designing, and implementing manufacturing QA programs, and ensuring that all GMP requirements are satisfied

  • Sets the vision and establishes priorities for the Quality function in alignment with regulatory requirement and the strategic direction accordance with shifting business needs

  • Accountable for effectively leading, driving and managing change for the functional area in a rapidly growing, highly dynamic environment

  • Directs activities of the entire Quality Organisation. Sets direction and priorities of activities. Assures completion of duties as agreed upon and understood. Final authority and responsibility for all Quality decisions

  • Ensures that the right resources and skills and capabilities of people in the Quality function are developed to enable the organisation to be flexible/adapt to the dynamic business conditions

  • Maintains internal quality system documentation, change control, specification, validation systems managing CAPAS and non-conformance to assure compliance to cGMP. Assures systems are in place to appropriately identify, review scope and impact, and disposition process variations and deviations from written standards and procedures

  • Maintains all necessary GMP or EH&S documentation to assure compliance to regulations. Assures Quality System and process are in place for Quality oversight

  • Maintains effective internal auditing program to provide assurance that the site maintains a compliant state. Gaps identified are remediated in a timely manner to prevent recurrence

  • Establishes, implements, and continuously improves multi-product strategy at site. Ensures validation programs are established and meeting regulatory and industry standards

  • Final Decision maker on lot disposition (approval or reject)

  • Plans, defines, sets requirements, assures implementation and organises systems to meet all GMP and client needs for GMP and QA activities

  • Actively engages in the identification, sharing and adoption of shared practices between sites/offices. Implements/supports business process for continuous improvements in all areas of manufacturing

  • Evaluate and maintain microbiological control strategies

  • Manage and implement the Quality Risk Management program

  • Perform other related duties and responsibilities as assigned

Director of Quality - Requirements:

  • Bachelors or Master's degree in Chemistry, Biology, or related scientific discipline and a minimum of ten (10) to fifteen (15) years of managerial experience in an aseptic manufacturing GMP environment

  • Experience in a CDMO environment is preferred

  • Demonstrated ability to effectively supervise and direct personnel and to plan and direct medium to large projects

  • Oral and written communication skill must be at a level appropriate for effective in-house communications, client contact and report preparation.

​​Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.