Relocation-Ready Senior QA Leader: cGMP & QMS

Storm Search; Cincinnati (OH); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Relocation Package Available within the US

Job summary

A leading pharmaceutical firm in Cincinnati is seeking a Senior Quality Assurance Manager to ensure compliance with cGMP and oversee the Quality Management System (QMS). The ideal candidate will have over 8 years of regulated manufacturing experience and be well-versed in FDA regulations. This role requires strong leadership and analytical skills, with a focus on continuous improvement in an FDA-regulated environment. The company offers a relocation package within the US.

Qualifications

• 8+ years of pharmaceutical or regulated manufacturing experience.
• 2+ years of team leadership or project management experience.
• Strong knowledge of 21 CFR Parts 210/211, 21 CFR Part 11, ICH Q7.

Responsibilities

• Lead and manage QA team activities to ensure compliance with cGMP and internal SOPs.
• Oversee and maintain the Quality Management System (QMS).
• Ensure timely investigation of OOS results, deviations, complaints, and CAPAs.

Skills

Strong analytical skills

Root cause analysis

Problem-solving skills

Leadership skills

Education

Bachelor’s degree in Chemistry, Microbiology, or related technical field

Master's degree

Tools

TrackWise eQMS

Job description

A leading pharmaceutical firm in Cincinnati is seeking a Senior Quality Assurance Manager to ensure compliance with cGMP and oversee the Quality Management System (QMS). The ideal candidate will have over 8 years of regulated manufacturing experience and be well-versed in FDA regulations. This role requires strong leadership and analytical skills, with a focus on continuous improvement in an FDA-regulated environment. The company offers a relocation package within the US.