Quality Services Manager
Quality Services Manager
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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 AbbVies 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 QAIT 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:
- QAIT 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 :
- Bachelors or Masters degree in a science or quality management discipline.
- At least 8 years of experience in the healthcare/pharmaceutical industry including 58 years in an FDA and EMAapproved 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
