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About AbbVie

AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.  For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.​

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(Senior) QA Product Manager / Team Leader - new Aseptic Sterile Fill Finish Biologics expansion!

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Quality Assurance
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1808729 Requisition #
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At AbbVie, our strength lies in our team of experts who conduct ground-breaking science on a global scale every day. In choosing your career & life path, choose to be extraordinary!


At AbbVie Ballytivnan, Sligo, we are expanding our facility into a multi-million dollar state of the art biologics plant that will bring ground breaking scientific research to real life solutions for our patients.


We are currently putting in place a highly technical, progressive team who will bring this expansion to reality. As part of that team, we are now recruiting a high calibre (Senior) QA Product Manager / Team Leader who will be a strong No. 2 for our Site Quality Head.


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 our 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. AbbVie has a manufacturing presence across the world in Singapore, Italy, Germany, Puerto Rico, the US and Ireland. Our strong pipeline of products means that we are continuously growing and therefore always looking for new talent who can develop and grow with us.


You will:

  • Recruit & lead the QP & QA Operations group, including batch release, product performance, Data Analytics, new products introduction (NPI), and interface with HPRA and FDA.
  • 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 AbbVie policies and procedures.   As Lead, you will mentor and coach your QPs, building their technical expertise.

  • 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.



Education & Experience:

  • Third level qualification in a relevant science discipline with 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

 


 

Equal Employment Opportunity Employer

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients.  As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

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