Senior Manager, Global Device Quality

1100 Mylan Pharmaceuticals Inc.; Dublin; On-site; EUR 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Pension

Bonus scheme

Work-life balance initiatives

Job summary

Viatris is seeking a Senior Manager, Global Device Quality to lead quality systems, drive regulatory compliance, and support device and combination product excellence across regions. You will align with Regulatory, Quality and Operations to maintain state-of-the-art standards and support ongoing inspections and CAPA.

The role requires extensive cGMP experience, EU FDA regulatory knowledge, and strong leadership, communication, and problem-solving skills in a global pharma/medical device

Qualifications

• Extensive experience in global cGMP regulations and quality systems.
• Strong knowledge of EU MDR, FDA regulations, 510(k) submissions and CE conformity.
• Proven leadership of quality and compliance functions in pharma/medical device sectors.

Responsibilities

• Provide leadership and drive improvements in quality systems to meet global regulatory requirements.
• Collaborate with Regulatory, Operations and other functions across regions.
• Lead inspections, audit responses and CAPA across global sites.
• Act as subject matter expert for QMS and conformity assessments for devices.
• Review and approve SOPs to ensure alignment with global policies.

Skills

Leadership

Regulatory compliance

Quality management

Cross-functional collaboration

Audit readiness

CAPA implementation

Effective communication

Education

Bachelor's or Master's degree in Engineering or Life Sciences

Tools

Microsoft Office

Job description

Viatris is seeking a Senior Manager, Global Device Quality to lead quality systems, drive regulatory compliance, and support device and combination product excellence across regions. You will align with Regulatory, Quality and Operations to maintain state-of-the-art standards and support ongoing inspections and CAPA.

The role requires extensive cGMP experience, EU FDA regulatory knowledge, and strong leadership, communication, and problem-solving skills in a global pharma/medical device