Sligo, Sligo Municipal Borough District, Ireland · On-site
Senior+
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 r…
Skills: Quality Assurance, Regulatory Compliance, GMP, Team Leadership, Change Management
Sligo, Sligo Municipal Borough District, Ireland · On-site
Senior
Company Description About AbbVie: AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative medicines and delivering excellence in pharmaceutical manufacturing. Job Description As t…
Skills: Pharmaceutical Manufacturing, Leadership, Operational Excellence, cGMP Compliance, Team Management
Sligo, Sligo Municipal Borough District, Ireland · On-site
Mid level
Company Description La mission d’AbbVie est de découvrir et produire des médicaments innovants qui apportent des solutions aux problèmes graves de santé d’aujourd’hui tout en relevant les défis médicaux de demain . Nous …
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Full-time
postgraduate degree
Posted 130d ago
~40 hrs/week
Responsibilities
Lead the Product QA, Regulatory, and Change Management teams to ensure all manufactured products meet regulatory and company standards. Oversee batch release, validation processes, and compliance with FDA and HPRA requirements.
Requirements
Requires an MSc in Industrial Pharmaceutical Science and at least 10 years of experience in the healthcare/pharma sector. Must have over 7 years of leadership experience and deep knowledge of GMP and FDA/EMA regulations.
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
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).
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.
Allergan is now part of AbbVie.
AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on LinkedIn for future updates.
Offices: Allergan plc, Dublin, Coolock D17 E400, IE · Morris Corporate Center III, 400 Interpace Parkway, Parsippany, NJ 07054, US · Parkway, Marlow, England SL7 1YL, GB · 301 W Howard Ln, Austin, TX 78753, US · 8301 Mars Dr, Hewitt, TX 76712, US
Health CareBiopharmaEducationBiotechnologyMedicalUniversitiesPharmaceutical
How many Management & Leadership jobs are open in Sligo, Ireland right now?
There are currently 23 open management & leadership positions in Sligo, Ireland listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Management & Leadership roles in Sligo, Ireland?
Companies currently hiring include Allergan, NORMAL A/S, AIR Sligo, Abbott, Amcor, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Management & Leadership jobs in Sligo, Ireland?
Yes — 3 of the 23 open management & leadership positions offer remote or hybrid work (1 remote, 2 hybrid).
How do I apply for Management & Leadership jobs in Sligo, Ireland?
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