QA Manager Sligo

FRS RECRUITMENT

SLIGO

My Client is an award winning US Biopharma Company and they are expanding their facility in the West of Ireland into a multi-million dollar state of the art biologics plant in Sligo. It is a very exciting time to be joining, they are currently in growth phase and have invested heavily into this site.They are currently putting in place a highly technical, progressive team who will bring this expansion to reality. As part of this start-up project, they are now recruiting a highly motivated and driven Senior QA Product Manager, who will be a strong ''No. 2'' for their Site Quality Head. This role is a key hire for them in line with their succession planning for the site in developing Quality Directors. You will be given the opportunity to make this role your own and put your own stamp on it. You will build and lead your own team, providing guidance and support to this highly engaged team of technical experts and Quality professionals building their technical expertise and empowering them whilst also driving results. Permanent position with excellent salary and full benefits package. Excellent career development opportunities with this company! Flexitime available for a healthy work, life, balance! Cultural Fit. There are genuinely a great company to work for and have a very low turnover of staff. Even though they are a major multinational and household name, the site has a lovely ''family feel''. Cultural fit for them is so important. They will always hire the candidate who is down to earth, personable, energetic and positive as well as being ambitious, self-motivated and a team player. They encourage ''outside the box'' thinking with new ideas always welcome. They also promote internally where at all possible. This client really does look after their staff and have consistently won various awards year on year which reflect this and their vision. The successful candidate will be degree qualified with minimum 5 years' management experience in the Biopharma/Pharmaceutical industry and minimum 3 years aseptic sterile fill finish manufacturing experience. A strong leader with excellent communication and interpersonal skills and a passion for making a difference in people lives. Key Responsibilities: You will be responsible for leading the complete product lifecycle - from the technical transfer of the new products to implementation of post-approval changes to the monitoring of overall performance of these products. You will also be involved in Global Projects and will work closely with the Senior Leadership team. Support the effective transfer of NPIs to the site and into commercial manufacturing. You will ordinate and work closely with external global teams including S&T, Regulatory and CMC QA. Lead the QP & QA Operations group, including batch release, product performance, Data Analytics and NPI. Ensure that all deviations or planned changes in production or quality control have been addressed according to all relevant regulatory requirements. 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. 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. Keep up to date on market and product (technical and scientific) progress and changes in regulations and quality management. You will have … Third level qualification in a relevant science discipline with minimum 5 years experience in the Biopharma/Pharmaceutical industry. Minimum 3 years experience in an aseptic sterile fill finish manufacturing environment an absolute requirement. Qualified Person (QP) status is preferred but not an absolute requirement (they will also provide educational assistance for you to complete this. NPI/Start-up experience in Biopharma/Pharma preferred. Proven People and Project Management experience and ability. Good communicator with excellent problem solving and influencing skills. If you are excited at the prospect of progressing your career to the next level and being part of an exciting biologics start-up in the beautiful West of Ireland, then I would love to speak with you! Next Steps: Click Apply! For more information and to review the full job spec and scope of this exciting Quality Leadership opportunity, please email your CV and/or contact me on my mobile. I would be delighted to speak with you and guide you through the whole process! You might also have searched for Quality Manager jobs, QA Manager jobs, Product Manager Jobs, Sligo Jobs, QA jobs Sligo.

1565 days ago