Senior Quality Assurance Manager

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

Relocation Package Available within the US

We’re seeking an experienced Senior Quality Assurance Manager to help lead quality operations within a highly regulated pharmaceutical and medical device manufacturing environment. Reporting to the Head of Quality, this role plays a key part in ensuring cGMP compliance, maintaining inspection readiness, and strengthening our Quality Management System (QMS).

If you thrive in FDA-regulated environments and enjoy driving continuous improvement, this is a high-visibility leadership opportunity.

What You’ll Do

• 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
• Maintain inspection readiness for FDA, EU, and global regulatory audits
• Partner cross-functionally on validation, change control, and process improvements
• Monitor and report quality KPIs to senior leadership
• Support Annual Product Reviews and Quality Review Board activities

What We’re Looking For

• Bachelor’s degree in Chemistry, Microbiology, or related technical field (Master’s preferred)
• 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
• Experience with eQMS systems (TrackWise preferred)
• Proven success supporting audits and regulatory inspections
• Strong analytical, root cause analysis, and problem-solving skills
• Certifications such as CQM, CQA, or Six Sigma Black Belt are a plus.