Quality Operations Lead

Would you like the opportunity to invest in your career and take your role to the next level? If the answer is yes, we have a hugely exciting opportunity for a high caliber Quality Operations Lead at our Clients state of the art biologics manufacturing facility. In this role you will be the No. 2 for the Site Quality Head, and you will lead and coach a 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 and the monitoring of overall performance of these products through to implementation of post-approval changes. This role is a key role in developing future technologies and people leaders within the company. As a result of this, you will have opportunities to be involved in Global Projects and to grow your career.

Why you should apply:

• You will be part of a highly technical, progressive team that will bring this expansion to reality.
• As Quality Operations Technical Lead, you will provide in-depth technical expertise on all day to day operational activities.
• As this expansion is a start-up project, in this role you will have the opportunity to lead and coach a small diverse, technical team of expert Quality professionals.

What you will be doing:

• 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 Quality Operations 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 policies and procedures.
• As manager, 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.

What you need to apply:

• You will have a 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 is desirable, but not essential.
• You should have a minimum 5 years industrial experience gained in an FDA and EMA approved pharmaceutical environment with proven people management capabilities
• Experience in an aseptic sterile fill finish manufacturing environment a distinct advantage