JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Purpose Statement:

The Senior Audit & Compliance Specialist role sits in our Infectious Disease (ID) Business Unit and reports to the Manager – Audits and Inspection Readiness.

The Senior Audit & Compliance Specialist will assist in:

upholding the supplier audit program and will take the lead in conducting supplier audits for the sites in the RMDx Division. This role is critical in maintaining a state of continuous inspection readiness and ensuring compliance with applicable regulatory requirements, including MDSAP and MDR/IVDR within the sites under the ID Business unit.

Key responsibilities:

• Assist with the RMDx Quality System by ensuring that the audit program (supplier, internal and external) complies with corporate and External Standards/Regulations.
• Coordinate and perform supplier audits, including planning, execution, and timely reporting for final closure in line with the RMDx site requirements. Independently work with the RMDx sites to understand the audit scope and accordingly conduct the audit.
• Maintain the supplier audit schedule and metrics at the ID BU level; track and trend audit findings to identify systemic issues.
• Support the ID sites in implementing Inspection Readiness activities.
• Prepare and host External inspections and corporate audits of the ID BU sites, including logistics, front and back-room support, documentation review, and auditee coaching.
• Apply critical thinking and assist the ID sites with any aged CAPAs related to external inspections and corporate audits, Complaint investigations and Field actions.
• Participate in quality system improvement initiatives and support regulatory submissions as needed.
• A willingness to participate in full scope QMS audits of the ID sites to ensure compliance with Corporate and External Standards/Regulations.
• Exhibit professional behaviour with both internal and external business associates that reflects positively on the company and aligns with the company’s policies and practices.

Basic Qualifications– Education / Experience / Skills

• Level 8 degree in life science, engineering, or quality assurance-related field.
• A minimum of 5 years of experience in a regulated manufacturing environment, preferably in a Quality or Regulatory role.
• Strong contemporary knowledge of relevant MDSAP, MDR/IVDR, cGMP Regulations and current industry trends.
• Experience in independently conducting and leading supplier audits
• Experience in Technical Documentation compilation/review for compliance with MDR/IVDR.
• Experience in supporting external inspections and corporate audit.

Preferred Qualifications

• Ability to work independently and collaboratively in a fast-paced environment.
• Ability to analyse and resolve business and compliance issues using independent judgment.
• Excellent organisational, communication, and problem-solving skills.
• Attention to detail and the ability to analyse information to identify patterns
• Ability to travel 40-50%
• Able to use Word, Excel, PowerPoint Point and Outlook.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

ID Infectious Disease:

LOCATION:

Ireland > Galway : Parkmore East Business Park

ADDITIONAL LOCATIONS:

WORK SHIFT:

Ie - 37.5Hst0 (Ireland)

TRAVEL:

Yes, 50 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Not Applicable