Head of Quality (Clinical Supplies)

The Company:

Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.

We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued expansion.

The Role:

Due to continued growth, we are seeking a driven and strategic Head of Quality CSM (Clinical Supplies Management) to lead a high performing team of 29 across the US and Europe. As well as utilising your leadership abilities you will be accountable for ensuring operations are carried out within the Quality team across the Clinigen CSM sites are completed in accordance with the requirements of the GxP regulations and guidelines, Clinigen Quality Systems and Industry Standards.

You will represent the Quality department on assigned project teams to provide a consistent approach to the formulation, preparation and execution of quality actions and to also ensure that these activities are implemented in a controlled manner in line with GxP and Clinigen Global Quality expectations.

Key Responsibilities:

• Follow, promote and enforce relevant SOPs, Job Aids, and Company policies and procedures
• Develop and implement the Quality department’s strategy for the CSM, to ensure it meets the divisional requirements and customer deliverables, as well as ensuring the departmental performance against goals.
• Implement and monitor all Quality Assurance systems to ensure compliance with GxP regulations and guidelines.
• Harmonize Quality Systems, to the extent feasible, with Regional, Divisional, and Global Quality.
• Implement and maintain a Quality Risk Management system to ensure risks are adequately controlled in accordance with current requirements (ICH Q9).
• High level resource planning.

Quality Operations:

• Act as the main point of contact on all Quality matters for Clinigen CSM, internally and externally.
• Coordinate and lead (where applicable), Competent Authority inspections, Client audits and self-inspections.
• Manage authorised activities to ensure operations do not compromise the quality of medicines and can demonstrate relevant compliance
• Demonstrate the application of activities and provisions in accordance with the Clinigen licences.                                                        
• Ensure any additional requirements imposed on certain products by national law are adhered to.
• Perform due diligence checks and ensure suppliers and customers are qualified.
• Manage the quality release of batches and communicate with relevant Qualified Persons/releasing teams
• Ensure appropriate transport requirements and methods for time temperature sensitive medicinal products and hazardous products are used.
• Ensure transport equipment is appropriately qualified.
• Responsible for ensuring the approval of any subcontracted activities which may impact upon GxP.

Quality Management System (QMS):

• Follow, review and assist in the improvement of the QMS for the Clinigen Group
• Ensure customer complaints are dealt with effectively
• Coordinate and promptly action any recall operations for medicinal products and to cooperate with Marketing Authorisation Holders and Competent Authorities
• Be aware of the issues surrounding falsified medicinal products
• Ensure there is a system, procedures and program to manage the validation or qualification of premises, equipment, processes and computerized systems
• Support IT systems (including eQMS and ClinigenOne projects), ensuring the systems are rolled out on a site level in a compliant manner.                                                             

• Substantial experience within the Pharmaceutical industry
• Extensive knowledge and experience within Quality and GxP processes
• Strong leadership/team management skills and experience.
• Credible and confident communicator (written and verbal) at all levels.
• Strategic thinker with the ability to influence at a senior level.
• Customer focused & commercially astute.
• Computer literate e.g. Word, Excel, PowerPoint, Visio
• Ability to exercise autonomy, good technical and scientific judgment, within the responsibilities defined within this job description
• Experience of developing and implementing operational plans for the areas of responsibility defined within this job description
• Ability to interpret and translate GxP guidelines into effective business strategies and processes
• Extensive people management experience
• Project management skills and able to prioritise work plans and have an ability to perform multiple tasks at one time
• Ability to initiate and maintain working relationships and communication links with the Clinigen Group, affiliated organisations and third-party contractors

Interested? We would love to hear from you, please apply today for consideration.