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 DescriptionIn AbbVie Ballytivnan, we are recruiting for a QA Compliance Specialist to join our team. This position will report into the Quality Systems Manager. The QA Compliance Specialist is responsible for documenting and establishing a quality system which ensures full compliance with all regulatory and AbbVie requirements.
The QA Compliance Specialist will have responsibility to assess and report on the effectiveness of the quality system to senior management.
What you will do:
- Coordinating the quality system, ensuring full compliance by all personnel with its requirements.
- Coordination of Product Quality Reviews activities.
- Management of all Technical Agreements from initiation, review, approval and storage.
- Coordination and Management of all Track and Trend activities to support Manufacturing and QC. Driving a QRM approach to all activities on site.
- Coordination and facilitation of all Site RCS and FMEA activities.
- Auditing the quality system per the documented internal audit schedule.
- Assisting in the documentation, investigation of and coordinating customer complaints/exceptions by ensuring implementation of effective corrective / preventive action where necessary.
- Ensuring that products manufactured at Abbvie Biologics Ballytivnan meet requirements of end users, of regulatory authorities and of the company.
- Measuring performance of the quality system and reporting on this at the management review meeting and during quality performance meetings.
- Coordinating change management, change control and Change planning activities. Monitoring quality performance and advising management personnel on major quality issues.
- Liaison with AbbVie Global Quality Assurance, FDA, HPRA and other regulatory bodies. Regulatory review.
- Initiation and Completion of Quality related investigations and verification of the effectiveness of CAPA’s as required.
- Establishing Corrective / Preventive Action system and procedures.
- Management of the Supplier program including the ASL, Performance metrics and Audit Schedules.
- Creation and approval of commodity specifications as required.
- Performance of Vendor audits as required Supporting all aspects of inspection readiness including preparation activities, logistic activities, and generation of follow up responses and management of proof books.
What you will need:
- A third level qualification in a science, quality or engineering discipline
- Minimum 3 years’ Experience in a similar role in a Pharmaceutical or Sterile Manufacturing environment
- A strong knowledge of regulatory requirements is required.
- Excellent written and verbal communication skills with a strong attention to detail.
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
Skills Required
- Third level qualification in a science, quality or engineering discipline
- Minimum 3 years experience in a Pharmaceutical or Sterile Manufacturing environment
- Strong knowledge of regulatory requirements
- Excellent written and verbal communication skills with strong attention to detail
AbbVie Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.
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Retirement Support — 401(k) contributions include a dollar-for-dollar match up to 6% plus an additional annual company contribution tied to age and service. Company-paid life insurance and other financial protections further strengthen long-term security.
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Parental & Family Support — Paid leave programs include up to 12 weeks at 100% for parental leave and separate paid caregiver leave, with eligibility after six months where noted. Adoption and surrogacy reimbursements and family-building resources add further support.
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Healthcare Strength — Health coverage begins on day one with medical, dental, vision, mental health, and prescription benefits, and preventive care covered at 100%. Options such as HSAs/FSAs and coverage for spouses/domestic partners and children up to age 26 broaden accessibility.
AbbVie Insights
What We Do
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.
