Quality and Regulatory Manager

PE Global is currently recruiting for a Quality and Regulatory Manager for a leading multi-national Pharma client based in Co Cork.

This is a permanent position.

Role:

Under broad administrative direction of the Managing Director the Responsible Person (RP) is responsible for the Quality Management System and Good Distribution Practices (GDP).  Directly manages day-to-day quality management & Good Distribution Practices (GDP) operations and facilitating resolution of issues. The RP at the site should have sufficient knowledge of GDP to conduct the role. This should include a knowledge of the EU GDP Guidelines, the Medicinal Products (Control of Wholesale Distribution) Regulations, as amended, and any supplementary guidance issued by the HPRA. The RP should be familiar with the wholesale activities conducted at the site and be continuously contactable.

Requirements:

• BS in a scientific discipline preferred; minimum of five (5) years in a cGMP/GDP facility in a Quality Assurance/Regulatory role. The preferred candidate must have experience in auditing in an international environment and Responsible Person experience as per the EU GDP Guidelines. Previous experience in managing or supervising direct reports is essential

• Excellent oral and written communication skills
• Knowledge of the EU GDP guidelines for Medicinal Products (Control of Wholesale Distribution) Regulations.
• Ability to effectively manage and participate in cross-functional problem solving teams
• Ability to read and understand the English language for the purpose of following instructions
• Strong leadership skills and ability to lead cross-functional teams
• Ability to develop and maintain cooperative working relationships with others.
• Ability to use good judgment in order to carry out detailed instructions

Interested candidates should submit an updated CV.

Please click the link below to apply, call Niamh on +353 21 4520313 or alternatively send an up to date CV to niamh.mcdonald@peglobal.net.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***