Quality Operations Manager / Lead

Science & Pharmaceutical
Science & Pharmaceutical
Sligo
Permanent
17333
Sligo
Permanent
17333

Quality Operations Manager / Lead

Are you interested in joining a company where you can unleash your full potential? This opportunity offers a chance to play a key role at an expanding multi-million-euro state of the art sterile filling plant that will bring ground-breaking scientific research to real life solutions. Be part of a diverse and innovative team where you will be a strong No. 2 for the Site Quality Head.


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 and the monitoring of overall performance of these products through to implementation of post-approval changes.

 

Key Responsibilities:

• 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 company 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.

 

Education:

• 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 desirable.

• You should have a minimum 5 years industrial experience gained in an FDA and EMA approved pharmaceutical environment with people management

• Experience in an aseptic sterile fill finish manufacturing environment an distinct advantage

 

Our client is an Equal Employment Opportunity Employer who values bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.

This role is well remunerated and offers ample opportunity to develop and advance your career.

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For a confidential discussion and more information on the role, please contact Davin Ferguson.

davin.ferguson@collinsmcnicholas.ie

071 9140251

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Your Consultant
Davin Ferguson
Principal Recruitment Consultant