AbbVie

Global biopharmaceutical company developing medicines

QA Operations Manager

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeSligo, IrelandNo salary listedIn-person

About the Job

Requirements

A degree-level qualification in a science discipline and previous experience in the healthcare or pharmaceutical industry.
An MSc in Industrial Pharmaceutical Science or a similar course recognized by a Regulatory Authority to permit Qualified Person status under Article 49 of Directive 2001/83/EC.
Industrial experience in an FDA- and EMA-approved pharmaceutical environment.
Previous supervisory and managerial experience in a manufacturing-related area in a biotechnology, pharmaceutical, or medical device organization.
Experience in manufacturing processes of drug product or substance, including aseptic filling, visual inspection of drug product, solutions preparation, and sterilization operations is preferable.
A proven track record in audit management and regulatory interaction management.

Responsibilities

Ensure that all New Product Introduction and commercial products manufactured at AbbVie Biologics are produced in accordance with the relevant Good Manufacturing Practices.
Own and oversee effective product transfer for New Product Introductions and transfer to commercial manufacturing processes within AbbVie Biologics.
Manage site Qualified Persons and Manufacturing Quality Assurance, including New Product Introduction and commercial batch release, product performance, and regulatory support.
Ensure that sterile and aseptic products manufactured at AbbVie Biologics Ballytivnan meet end-user, regulatory authority, and company requirements.
Verify that batches are manufactured in compliance with the provisions of the marketing authorization.
Ensure manufacturing complies with applicable Good Manufacturing Practice, including EU GMP Annex 1 and FDA regulations.
Ensure principal manufacturing and testing processes are appropriately validated, taking actual production conditions and manufacturing records into account.
Confirm that exceptions or planned changes in production or quality control are authorized by responsible persons under a defined system, and that changes requiring a variation to the marketing or manufacturing authorization are notified to and authorized by the relevant authority.
Maintain current knowledge and experience in light of technical and scientific progress and changes in quality management relevant to products requiring certification.
Liaise with AbbVie global Quality Assurance and Regulatory groups, the FDA, the HPRA, and other regulatory bodies where applicable.
Liaise with AbbVie Product Quality, Science and Technology, and Regulatory Affairs regarding product filing support.
Ensure effective transfer of New Product Introductions to the site and progress them into clinical or commercial manufacturing.
Work with the QA Director, Quality Control, and Quality Systems group to ensure the site meets customer, quality service, regulatory, and financial goals.

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

About the Company

AbbVie

Global biopharmaceutical company developing medicines

AbbVie is a global biopharmaceutical company that develops and sells medicines to treat serious health conditions. Its portfolio spans immunology, oncology, virology, neuroscience, and aesthetics, with products designed to modulate the immune system, target disease pathways, or support medical aesthetics. AbbVie compounds its products through a heavy emphasis on research and development, investing billions to build a steady pipeline of new therapies. Its medicines are brought to market by selling to healthcare providers, hospitals, and clinics, and in some cases directly to patients via prescriptions. The company differentiates itself through a wide, globally distributed product line, substantial R&D investment, and a commitment to sustainability and patient care, including science-based targets. AbbVie’s goal is to improve patient outcomes by delivering effective treatments for unmet medical needs while pursuing long-term, responsible growth across healthcare markets.

Company size: 10,001+
Company stage: IPO
Headquarters: North Chicago, IL
Founded: 1888

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