Global Medical Device Quality Leader

AbbVie; Westport; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Medical Insurance

401(k)

Paid Time Off

Job summary

AbbVie—a leader in innovative medicines and devices—seeks a Senior Quality Assurance Operations Manager to oversee quality for combination products and medical devices. You will lead a team, drive regulatory conformance, and coordinate across AbbVie plants and contract manufacturers to ensure on-time, compliant product delivery.

The role demands strong analytical skills, urgency handling, and collaboration with Regulatory Affairs to develop global QA strategies and improve quality metrics for

Qualifications

• Bachelor’s degree in Life Science or related field with strong technical/problem-solving abilities.
• Minimum 7+ years in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support.
• Experience in high-urgency environments with cross-functional leadership.

Responsibilities

• Ensure delivery of quality elements for on-market support of combination products and medical devices.
• Support Global Product Quality Assurance strategy and implement agreed plans at AbbVie plants.
• Make key decisions on quality, compliance and regulatory conformance for devices and combination products.
• Lead collection and improvement of quality metrics for management reviews with senior leadership.
• Oversee a team of SMEs and coordinate activities with internal and external partners to achieve on-time quality deliverables.

Skills

Quality Assurance

Regulatory Compliance

Leadership

Analytical Skills

Education

Bachelor’s Degree in Life Science

Job description

AbbVie—a leader in innovative medicines and devices—seeks a Senior Quality Assurance Operations Manager to oversee quality for combination products and medical devices. You will lead a team, drive regulatory conformance, and coordinate across AbbVie plants and contract manufacturers to ensure on-time, compliant product delivery.

The role demands strong analytical skills, urgency handling, and collaboration with Regulatory Affairs to develop global QA strategies and improve quality metrics for