Senior QA Quality Systems Lead – Investigations & CAPA

Viatris; United States; On-site; USD 66,000 - 127,000; Full time

Benefits offered by this job

Competitive salaries

Inclusive environment

Job summary

Mylan Technologies, Inc. in the United States seeks a Manager, Quality Systems to lead complex investigations, triage deviations, and drive CAPAs.

You will compile reports, present to leadership, and oversee critical elements of the Site Quality System while guiding continuous improvement projects. The role requires a BS with 10+ years GMP experience, strong communication and technical writing skills, and thorough knowledge of cGMP and change control.

Qualifications

• BS degree and 10+ years of relevant experience in a GMP environment or equivalent.
• Working knowledge of cGMP and Quality Systems; change control processes.
• Excellent written and verbal communication skills.
• Experience with building investigation reports and corresponding CAPAs.

Responsibilities

• Lead complex investigations, trends, and CAPA actions with reports.
• Represent QA in triage of deviations, initial evaluation, containment actions.
• Lead cross-functional problem solving for investigations.
• Compile/analyze data for APRs, Management Review, Site Metrics, and prepare reports/slides.
• Provide oversight for Site Quality System elements.
• Mentor Quality Systems staff and support external audits.

Skills

Strong communication

Technical writing

Statistical analysis

Education

Bachelor's degree in a relevant field

Tools

Change control systems

Job description

Mylan Technologies, Inc. in the United States seeks a Manager, Quality Systems to lead complex investigations, triage deviations, and drive CAPAs.

You will compile reports, present to leadership, and oversee critical elements of the Site Quality System while guiding continuous improvement projects. The role requires a BS with 10+ years GMP experience, strong communication and technical writing skills, and thorough knowledge of cGMP and change control.