Job Description We 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 Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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