Quality Services Manager

Job title:

Quality Services Manager

Company:

AbbVie

Job description

Company DescriptionAbbVie’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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on , , , and .Job DescriptionWe are seeking a dedicated and experienced Quality Services Manager to join our team in Manorhamilton Road, Sligo. You will play a crucial role in coordinating the development and maintenance of our quality systems, ensuring compliance with all regulatory requirements. This position ensures that AbbVie’s manufactured products meet the standards of GMP, our patients, regulatory authorities, and the company.Key Responsibilities:

• Lead and manage the Quality Services Team, which supports QA-IT, QC Laboratory equipment program management, purchasing and capacity planning for quality functions, quality risk management, data governance and digital strategic initiatives.
• Oversee and coordinate all activities within the Quality Services group, including:

• QA-IT LIMS, Empower, SAP, and lab connectivity.
• Integrated digital laboratory initiatives (e.g. Digital Lab, Lab of the Future, instrument connect etc).
• Budget reviews and capital/resource planning (headcount and projects).
• Operational excellence and continuous improvement activities.
• Data integrity and governance program.
• QC laboratory equipment installation, maintenance, upgrades, and future planning.
• Specific projects such as laboratory upgrade and lab of the future deployment etc.
• Develop and manage a robust Quality Support System, ensuring compliance with major GMP standards and regulations such as:

• FDA 21 CFR Parts 210, 211, and Q7A.
• ICH Q7, Q8, Q9, Q10, and Q11.
• European Commission GMP, Volume 4.
• AbbVie Quality Assurance policies.
• Collaborate with AbbVie QA, FDA, HPRA, and other regulatory bodies as necessary.
• Lead preparations and participate in internal and external audits, addressing audit findings effectively.
• Ensure all products manufactured at AbbVie Ireland NL B.V. meet the requirements of end users, regulatory authorities, and the company.
• Serve as the designee for the Quality Director when needed.
• Uphold and support all EHS & E standards, procedures, and policies.

Qualifications

• Bachelor’s or Master’s degree in a science or quality management discipline.
• At least 8 years of experience in the healthcare/pharmaceutical industry, including 5-8 years in an FDA and EMA-approved pharmaceutical or device environment.
• Minimum of 2 years of supervisory experience.
• Proven expertise and understanding of laboratory operations
• Strong knowledge of GMP requirements and regulations.

Additional InformationAbbVie 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, visitUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Expected salary

Location

Sligo

Job date

Wed, 23 Apr 2025 03:02:36 GMT

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