Find New product introduction manager Jobs in Ireland

QA Operations Manager
AbbVie —Sligo, County Sligo
- Full-time
- Master's degree
- Supervising experience
- No degree
7d
Assistant Store Manager
Superdry —Kildare Village, County Kildare
Global Technical Service Manager (m/f/d)
Sonova —Tullamore, County Offaly
- Hybrid work
- English
- Bachelor's degree
- Budgeting
Engagement Manager, Aircraft Investment Advisory
Alton Aviation Consultancy —Dublin, County Dublin
- Microsoft Excel
- Management
- English
IT Manager - Parkmore/Mervue/Athlone Sites
Medtronic —Galway, County Galway
- €89,680–€134,520 a year
- Full-time
- Computer Science
- Engineering
- Master's degree
8d
Senior Process Engineer
Hovione —Cork, County Cork
- Engineering
- English
- Microsoft Office
Quality Specialist Launch Team
Ball Corporation —Waterford, County Waterford
- €87,000–€145,000 a year
- English
- Computer skills
- Manufacturing
- Employee assistance program
- Life insurance
Quick apply
Director, Quality
Integer Holdings Corporation —Wexford, County Wexford
- Full-time
- Master's degree
- Bachelor's degree
- Communication skills
Quick apply
10d
Quality Engineering Manager
Embecta —Dún Laoghaire, County Dublin
- Full-time
- Engineering
- Communication skills
Planning Manager
Dexcom —Athenry, County Galway
- Full-time
- Microsoft Excel
- Oracle
- Engineering
3d
Lead PM, Program/Project Manager
Analog Devices —Cork, County Cork
- Full-time
- Computer Science
- Data analysis skills
- System design
Quality Assurance Associate Specialist
MSD —Carlow, County Carlow
- Full-time
- Hybrid work
- Engineering
- Quality control
- Manufacturing
2d
Production Team Leader
Takeda Pharmaceutical —Wicklow, County Wicklow
- €57,800–€79,420 a year
- Full-time
- Engineering
- Leaving certificate
- Continuous improvement
- Fuel card
- Employee stock purchase plan
Multi Platform Partnerships Manager, RTÉ Media Sales
RTÉ —Dublin, County Dublin
- €51,039–€85,647 a year
- Communication skills
- Negotiation
8d
Supply Chain Manager
IDEX Pump Technologies (Ireland) Limited —Shannon, County Clare
- Full-time
- Oracle
- ERP systems
- Analysis skills
9d
CitiService Director
Citi —Dublin, County Dublin
- €130,000 a year
- Full-time
- Hybrid work
- No degree
- Communication skills
Reseller Operations - French Supply Chain Account Manager - 11 month
Apple —Cork, County Cork
- Microsoft Excel
- Sales
- Engineering
Quality Assurance Senior Manager - Pharma
Hovione —Cork, County Cork
- English
- Master's degree
- No degree
Global Direct Sourcing Manager - Amsterdam/Dublin
CRH Group Services Ltd. —Dublin, County Dublin
- Full-time
- English
- Analysis skills
- In-person
Quick apply
Facilities Engineer
PCI Pharma Services —Stamullin, County Meath
- Full-time
- AutoCAD
- Engineering
- Microsoft Office

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QA Operations Manager

AbbVie -
Sligo, County Sligo

Apply Now

Job details

Full-time
7 days ago

Qualifications

Master's degree
Supervising experience
Manufacturing

Full job description

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Reporting to the QA Director, the QA Operations Manager will ensure that sterile products (New Product Introduction (NPI) and Commercial) are manufactured, filled and released at AbbVie Biologics Ballytivnan (ABB) meet the regulatory requirements for patient safety and efficacy and comply with Regulatory Authority Requirements that the product is been released too.

Main duties and responsibilities:

Ensure that all NPI and Commercial Products manufactured at AbbVie Biologics are in accordance with the relevant GMPs.
Ownership and Accountability for the Management and oversight for effective product transfer of NPIs and transfer to commercial manufacturing processes within AbbVie Biologics.
Management of site QPs and Manufacturing Quality Assurance (MQA), including NPI and Commercial batch release, product performance and regulatory support.
Ensuring that sterile and aseptic products manufactured at ABB meet requirements of end users, Regulatory Authorities and of the company.
Verify that batches are manufactured and comply with the provisions of the marketing authorisation.
Ensure manufacture has been carried out in accordance with all applicable Good Manufacturing Practice, e.g., EU GMP Annex 1 and FDA regulations.
Ensure the principal manufacturing and testing processes have been appropriately validated; account has been taken of the actual production conditions and manufacturing records.
Confirm that any exceptions or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system. Any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority.
Maintain knowledge and experience is up to date in the light of technical and scientific progress and changes in quality management relevant to the products they are required to certify.
Liaise with AbbVie global Quality Assurance and Regulatory groups, FDA, HPRA and other Regulatory bodies (where applicable).
Liaise with AbbVie Product Quality, S&T and Regulatory affairs function in relation to product filing support.
Ensure effective transfer of NPIs to site and its progress into clinical / commercial manufacturing
Work with QA Director, Quality Control and Quality Systems group to ensure site meets its customer, quality service, regulatory and financial goals.

Qualifications

Degree level qualification in a science discipline with previous 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
Industrial experience gained in a FDA and EMA approved pharmaceutical environment.
Previous supervisory and managerial experience in a manufacturing related area in a Biotechnology, Pharmaceutical or Medical Device organisation
Experience in manufacturing processes of drug product/substance, including aseptic filling, visual inspection of drug product, solutions preparation, and sterilization operations preferable.
Proven track record in audit management and regulatory interaction management.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Apply Now

Refine Your Search

new product introduction manager jobs in ireland

QA Operations Manager

Assistant Store Manager

Global Technical Service Manager (m/f/d)

Engagement Manager, Aircraft Investment Advisory

IT Manager - Parkmore/Mervue/Athlone Sites

Senior Process Engineer

Quality Specialist Launch Team

Director, Quality

Quality Engineering Manager

Planning Manager

Lead PM, Program/Project Manager

Quality Assurance Associate Specialist

Production Team Leader

Multi Platform Partnerships Manager, RTÉ Media Sales

Supply Chain Manager

CitiService Director

Reseller Operations - French Supply Chain Account Manager - 11 month

Quality Assurance Senior Manager - Pharma

Global Direct Sourcing Manager - Amsterdam/Dublin

Facilities Engineer

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