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Senior Manager, Product QA, Sligo



Sligo, Ireland 

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Job Description:

The Opportunity

Our client, a global leader in pharmaceuticals are seeking a high caliber Snr Manager, Product QA to lead and coach a diverse, technical team of 6 experienced Quality and Regulatory professionals, including 3 QPs. The successful candidate will be responsible for leading the complete product lifecycle - from the technical transfer of investigational new products to implementation of post-approval changes to the monitoring of overall performance for our commercially marketed drug products and APIs.

This role is a key role in developing Quality Directors within the manufacturing network. This position requires a strong leader who will be the Quality Director delegate as needed and partner closely with our Senior Leadership team.  As a result of this and the heavy involvement with NPI activity, you will have opportunities to be involved in Global Projects and to grow your career.

The Role

  • Lead the QP and Regulatory group, including batch release, product performance, Data Analytics, new products introduction (NPI), and interface with HPRA and FDA.
  • Ensure product manufacture is in accordance with Good Manufacturing Practice and meets requirements of our patients, Regulatory Authorities (FDA, HPRA etc) and of the company
  • Partner with internal and external Regulatory groups, FDA, HPRA etc while liaising with operations, technical operations, science & technology teams in relation to product filing support.
  • Have responsibility for the oversight of product performance process, product quality Review, complaints and product track and trend
  • Ensure compliance with all processes and procedures while maintaining the Quality Risk Management (QRM) program on site
  • Have knowledge and experience up to date on market and product (technical and scientific) progress and changes in regulations and quality management related to our range of products.
  • In this role, you will act as the primary delegate to the Quality Director and regularly interact with the Senior Management Team.
  • NPI is key to the growth of our business. As the Snr QA Product Manager, you will support the effective transfer of NPIs to site and into commercial manufacturing; coordinating with external global teams including, but not limited to S&T, Regulatory, CMC QA
  • You will empower your team to ensure any deviations or planned changes in production or quality control have been addressed according to all relevant regulatory requirements and AbbVie policies and procedures. As Lead, you will mentor and coach your QPs, building their technical expertise.
  • Through your team, you will ensure all the necessary checks and tests are performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes while ensuring quality control documentation is completed and endorsed

The Person

  • Third level qualification in a science discipline with minimum 5 years’ experience in the healthcare/pharmaceutical industry
  • MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
  • Minimum 5 years industrial experience gained in a FDA and EMA approved pharmaceutical environment.

Employment Type:

Full time
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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