About this opportunity
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
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 164 comparable Manager Quality roles across 51 biopharma companies.
Salary context
44 of 164 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 164 comparable roles
+ 19 more countries
Seniority mix
164 of 164 peers have a known seniority level
Therapeutic area mix
0 of 164 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.