Senior Product QA Manager
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
We are now hiring a Senior Product QA Manager to join our team in Manorhamilton Road, Sligo. This leadership role ensures that all products manufactured at Sligo Manorhamilton Road meet the requirements of end users, regulatory authorities (including FDA and HPRA), and company standards. The Senior Product QA Manager is responsible for compliance with marketing authorisations, current Good Manufacturing Practices (GMP), and supporting New Product Introductions (NPIs).
Responsibilities:
Manage QP , Regulatory, Change Management and New Product Introduction teams, including annual goal setting, performance reviews, development, and talent management.
Ensure products (commercial and NPI/CTS) are manufactured and released in line with marketing authorisation, GMP, and company quality systems.
Lead batch review and release, documentation, checks, and test completion.
Oversee validation of manufacturing and testing processes and accurate record keeping.
Provide quality governance on deviations, planned changes, and exception reporting with proper authorisations and regulatory notifications.
Support NPI activities: change plan review, validation, documentation approval, and release of CTS batches.
Execute regulatory requests and submissions, engage directly with regulatory agencies (FDA, HPRA).
Chair Change Review Boards, approve changes, oversee completion of QA tasks.
Conduct internal/external audits and participate in regulatory/customer inspections.
Manage complaint investigations, coordinate product recalls, and address quality defects.
Ensure compliance with FDA CFR Parts 210/211/Q7, EU GMPs (ICH Q7, Volume 4), and AbbVie QA Policies.
Review and approve Product Quality Reviews (PQRs) and track finished product data.
Provide QP oversight for SAP, LIMS setup changes, and manage site quality metrics.
Act as Designee for the Quality Director when required.
Lead department/site goals, provide technical leadership/guidance on QP/regulatory matters, and present technical data for decision-making.
Qualifications
MSc in Industrial Pharmaceutical Science (or a comparable course recognized for QP status per Article 49 of Directive 2001/83/EC).
Minimum 10 years' experience in the healthcare/pharma sector within FDA/EMA approved environments.
Demonstrated experience leading teams, with 7+ years in leadership roles
Demonstrated attention to detail, strong problem-solving and innovative thinking abilities.
Results-driven mindset with proven prioritization skills and commitment to quality.
High integrity, strong work ethic, excellent verbal/written communication, and interpersonal skills.
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.