Global Quality Lead (Assurance)
This role is responsible for developing and maintaining Global Quality Standards across all sites, ensuring compliance with global policies and procedures.
Key Responsibilities
* Create key performance indicators and process metrics to measure the performance and effectiveness of the Pharmaceutical Quality System (PQS).
* Monitor and report on trends within the PQS, engaging with the business to address any issues promptly to maintain operational quality performance.
* Support continuous improvement by analysing data from key business areas and ensuring process compliance through training and governance.
* Own the Pharmaceutical Quality System through development of processes, compliance with regulations, training, and governance of the process.
* Host forums with sites to promote discussions and aid consistency across sites, encouraging problem solving and continuous improvement.
* Support regulatory compliance, client audits, and regulatory inspections, lead process improvements, and develop training materials for global rollout.
Requirements
* Have eligibility to work in the UK or possess a valid work permit that will allow you to take up full-time employment in the UK.
* Degree level qualification in a Life Science or technical discipline or related field, or significant experience in a similar technical role in lieu of a degree.
* Significant experience working within an established Quality System within the Pharmaceutical Industry.
* Significant experience working within the Quality compliance function with experience in multiple Quality Compliance aspects.
* Significant experience with the generation, execution, and review of quality compliance documents in pharmaceutical manufacturing and/or packaging facility, e.g., change management, deviation/investigations, CAPA, product complaints.
* Proven working knowledge of Pharmaceutical legislation and rules governing manufacture and distribution of products.
Desirable Requirements
* A degree in a Science/Business discipline.
* Significant experience in conducting/supporting a Quality Risk Management process.
* Previous experience in writing and producing detailed reports.
* Lean Six Sigma/continuous improvement experience.
* Experience of conducting Audits (Internal/External/Audit Qualification).
* Experience of project management/leading teams.
* Previous experience of generating training material and the delivery of training.