This leading global biologics organisation provides and offers comprehensive integrated and customisable services to the bio-pharmaceutical and related industry sectors, including some of the largest biopharma and pharma organisations worldwide. Services include contract development through to contract manufacturing. This business has announced expansions into geographies such as the U.S. and most recently Ireland, where a significant investment was undertaken to build a new cell culture green-field manufacturing site, which has recently been completed. The Irish site now holds the accolade as being one of the largest single use biologics manufacturing plants globally. It has been designed to run continuous bio-processing, a next-generation manufacturing technology, which will be implemented for the first time at this site, which employs in the region of 400 staff. An exciting opportunity has arisen for a Senior QP - Associate Director to join the organisation as it ramps up into commercial manufacturing whilst leading a laboratory operation at site.

The Position:

The individual will be responsible and accountable for ensuring GMP production quality system is in place, adhering to all regulatory, cGMP and company requirements. They will ensure all structures are in place to monitor, measure and ensure successful programme is applied. They will be responsible to ensure all necessary plans and standards are achieved consistently maintaining a high level of quality.

• Act as site QP responsible for manufacturing release of DS/DP and a participant in GMP production activities, such as process transfer, validation etc.
• Close monitoring of the construction quality of GMP production.
• Work with functional department to create department SOP's and assure compliance with EU/FDA GMP regulations.
• Audit functional department quality documents to assure data integrity and provide guidance from QA perspective.
• Be responsible for setting up online DS/DP QA team for site.
• Work closely with manufacturing team, to support all GMP production activities.
• Perform routine audit for manufacturing area, to assure GMP production is in compliance with all regulatory, market, EU, FDA and company standards.
• Be accountable to review and approve manufacturing generated documents, including but not limited to: qualification plan/report, SOPs, batch records, IPC results, deviation, CAPA, change control, QRM, etc.
• Ensure accurate reporting of MFG generated results and assure data integrity in daily activity.
• Training subordinate to meet the demand of company fast growth.
• Responsible for managing a team of employees across QA for DS/DP, ensuring all associated performance management requirements are in place for each employee and relevant reviews are carried out regularly.
• Ensure all relevant training is provided to employees who carry out DS online duties to ensure site SOPs are followed, accurate identification of deviations or any other quality issues.
• Liase actively with cross functional teams when release DS/DP.
• Other quality activities as assigned.

The Person:

• Degree in Vaccine and Biopharmaceutical Science or related.
• Must meet the educational requirements of a Qualified Person as per EU Directive 2001/83/EC and have strong QA experience.
• Ideally 15 years working experience in vaccine/ biopharma or similar experience in a pharma/science background.
• It is desirable that this individual has a knowledge of legislative, regulatory, market, biologics, and data integrity requirements.
• Must have effective communication skills with demonstrated ability to work in a matrix environment.
• Strong leadership competencies with demonstrated management, 10+ years' experience.

To learn more about this role apply online or contact Anita Osibuamhe on + 353 1 6321870 for a confidential discussion.