Senior QA Executive

Senior QA Executive

Viatris

Inverin, Ireland

The Role & What You Will Be Doing

As Senior Quality Assurance Executive, you will support the delivery of 3-year commercialization program for a new cartridge-filling product line, providing strategic and operational quality oversight for a development and commercialization project within a sterile manufacturing environment. The role ensures that quality systems, compliance requirements, and risk controls are fully integrated to support successful development, regulatory approval, and commercial launch.

Every day, we rise to the challenge to make a difference and here’s how the Senior Quality Assurance Executive role will make an impact:

• Act as Quality Subject Matter Expert across the full project lifecycle, from development through to commercialization
• Ensure compliance with GMP, regulatory requirements, and data integrity standards
• Define and oversee quality strategies aligned with sterile manufacturing and aseptic processes
• Lead quality risk management activities, ensuring risks are identified, assessed, and mitigated effectively
• Provide oversight of validation activities (e.g., process validation, cleaning validation, sterilization)
• Ensure readiness for regulatory inspections and support audit activities as required
• Partner with cross-functional teams (e.g., MS&T, Engineering, QC) to ensure alignment and quality integration
• Oversee deviation, CAPA, and change control processes to support robust quality outcomes
• Support regulatory submissions with QA input and approval where required

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Bachelor’s degree (or equivalent) in a Science related discipline with Pharmaceutical/Medical Device Quality Assurance/Control or related department is essential
• Significant experience in Quality Assurance within a regulated, sterile or aseptic manufacturing environment
• Strong knowledge of GMP, regulatory expectations, and data integrity requirements
• Proven experience supporting development and commercialization programs
• Strong risk management and decision-making capability
• Ability to influence and lead within a cross-functional, matrix environment
• Knowledge of Quality Risk Management Systems, cGMPS i.e., USFDA, 2003/94/EC, MHRA and WHO
• Experience and understanding in the use of Data Sharing Software Packages an advantage.