Quality Director

Primary Objective

To drive the company’s Quality Assurance and Quality Control strategy, Quality Management System and Quality policies, assuring compliance to MHRA GXP regulations across products and all regulatory audit and inspection activities. Responsible for translating the company’s quality strategy into SOPs, tactical policies, processes, and procedures to ensure compliance with meeting global regulatory standards at all times.

Role Responsibilities:

• Define and implement a quality strategy for licensed and non-licensed products
• Lead the development, implementation and management of GXP quality and compliance systems and policies
• Lead the Quality Assurance department in all GXP functional areas (GMP, GLP, GCP, GXP document control, GXP training) as customer programs transition to release readiness
• Devise and recommend methods and procedures for continuous improvement of product quality, hygiene and / or manufacturing processes within the Quality Management System
• Develop corporate and/or other organizational polices related to GXP compliance and oversee their implementation, including quality standards and SOPs
• Maintain good working relationships with regulatory authorities and trade associations and become an influencer for laws, regulations and standards whilst planning for future requirements
• Responsible for the overall direction, coordination, and evaluation of the reporting departments (QA, QC, RA, and Validation) and functions
• Ensure company is regulatory inspection ready at all times (Regulatory Agencies and Client)
• Plan, coordinate, and direct PAI readiness for new and existing customers
• Ensure products and processes meet all specifications and requirements before approving the release to customers
• Develop and manage relationships with senior Quality representatives from customers, suppliers, and collaborators
• Develop, implement and monitor Quality operation budget to ensure compliance with approved expense limitations. Determine cause of variance to budget and applicable corrective actions.
• Keep current on changes in industry and regulatory standards for GXP requirements and advise on business impact
• Advise Company’s Executive Team and parent company on the implications and risks related to key Quality issues and important strategic decisions; keeping all posted, on a timely basis
• Host regulatory and client representatives in audits and inspections
• Lead and coordinate the efforts within the entire operation to formulate and implement corrective actions to internal and external assessments
• The above is not a complete and exhaustive list and other duties may be required to be undertaken as and when necessary.

Skills & Competencies:

• Minimum of a Bachelors’ scientific degree (ideally bio-chemistry, life sciences, or related field)
• At least 10 years of experience in positions of substantial Quality management responsibility within the Life Sciences industry
• Substantial experience in leading and participating in regulatory inspections and preparing staff for regulatory inspections
• Ability to effectively present information to top management, public groups, and/or boards of directors
• Demonstrated ability in setting successful quality strategies and building and leading the function
• Extensive knowledge of biopharmaceutical manufacturing processes, equipment, and testing
• Knowledge of relevant regulations, including FDA, EMEA, ICH.