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Senior Product QA Manager (Qualified Person) – Drug Product, API & Biologics

  • Sligo, Irlandia
  • Kierownik
  • 02.01.2019

    Pracodawca ma prawo zakończyć rekrutację we wcześniejszym terminie.

    Job Description

    I chose AbbVie.
    I chose ambition & innovation,
    I chose to explore a thriving career with AbbVie,
    Choose AbbVie!
     
    Based in beautiful Sligo, Ireland, we have dedicated capabilities for potent active pharmaceutical ingredient, drug product and biologics manufacturing. We focus on creative new technologies and with our high performing team; we develop and deliver products and processes to support AbbVie’s wider global needs.
     
    We are always looking for talented people to join our team and, when we find them, we make it our business to treat them well. Choose AbbVie if you share our real passion for improving the health and lives of patients.
    Senior Product QA Manager (Qualified Person)
    Drug Product, API & Biologics
    We are currently sourcing a high calibre Senior Product QA Manager to lead and coach our diverse, technical team of expert Quality and Regulatory professionals, including  QPs. 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 for our commercially marketed drug products, biologics and APIs. 
     
    Our site is a key strategic site for new product introduction.  In your new role, you will be an integral part of this as the Quality Lead on Global Technical Transfer teams. This will include significant involvement in Pre-Authorization Inspections from regulatory authorities including the HPRA/EMA and FDA. We will be looking for a key Quality Talent to help us to maintain the very strong compliance reputation that we have gained through multiple PAI and GMP inspections over the last number of years.
     
    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 and our significant involvement with NPI activity, you will have opportunities to be involved in Global Projects and to grow your career. AbbVie has both Small and Large Molecule Manufacturing 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.

    Key Responsibilities:

    The successful candidate will:
    • 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 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.

    Qualifications

    Education & Experience:
    • 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
    • Fluent English – written & verbal
    Additional Information: