Mantell Associates is partnered with an innovative organisation searching for a Quality Director to join and manage a team of 20.
Quality Director - Responsibilities:
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 Organization. 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 organization 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 organizes systems to meet all GMP and client needs for GMP and QA activities, by written and verbal communications to all appropriate groups. Defines Quality metrics, monitors them and initiates appropriate actions if needed
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.
Quality Director - 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.