Quality Director

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A global pharmaceutical start-up company are recruiting a Quality Director for their manufacturing site in Clare.

They are a state-of-the-art contract development and manufacturing organisation (CDMO) providing both primary formulation and manufacturing, and secondary manufacturing and packaging of small molecules.

Title: Quality Director

Reporting to: Global VP of Quality

Job Purpose:

Overall responsibility for Quality Assurance, Quality Control. This is a key leadership role for the organisation with QA, QC, Regulatory Affairs and QP all reporting directly.

Key Accountabilities:

* Provide leadership to the Quality function.

* Resourcing, performance management and development of individuals in quality.

* Maintain an effective quality management system.

* Lead/support site inspections by third parties, regulatory bodies and agencies.

* Prepare and control budgets for quality department.

* Ensure compliance with data integrity requirements.

* Review effectiveness of quality systems.

* Foster a culture or continuous improvement.

* Review and approval of SOP's and other quality related documents.

* Ensure GMP compliance in all activities on site, in conjunction with management and operations.

* Work closely with operations and process development to ensure that quality is built into all processes and products.

* Any other relevant duties as required.

Qualifications:

Minimum degree in chemistry or another relevant science subject

Experience:

10 years' experience in quality

Minimum 5 years at Quality Management level

Regulated industries

Regulatory Audits

Multi-national experience

Extremely competitive salary and benefits package on offer.

Please get in contact if you would like to hear more about this exciting opportunity and I can provide you with full details on.

Sthree UK is acting as an Employment Agency in relation to this vacancy.