Senior QA Manager

  • Sligo
  • Permanent
  • JO-1812-64084_1548325886

Summary

As this expansion is a start-up project, in this role you will have the opportunity to build your very own team from scratch and then lead and coach this diverse, technical team of expert Quality professionals. You 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 of these products.

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 you will have opportunities to be involved in Global Projects and to grow your career. Our client has a manufacturing presence across the world in Singapore, Italy, Germany, Puerto Rico, the US and Ireland.

Responsibilities

  • Lead the QP & QA Operations group (once in place), 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 Senior 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 and 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 company polices 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.

Requirements

  • Third level qualification in a relevant science discipline with a minimum 5 years' experience in the 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 an FDA and EMA approved pharmaceutical environment.

  • Minimum 3 years' experience in an aseptic sterile fill finish manufacturing environment

  • People Management experience is required

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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