Senior QMS Engineer: Quality Systems & CAPA Leader

Aphena Pharma Solutions; Easton (MD); On-site; USD 110,000 - 150,000; Full time

Job summary

Aphena Pharma Solutions' Liquid and Topicals Division in Easton, MD seeks a Senior Quality Systems Engineer to lead the QMS within a highly regulated CMO/CDMO environment. You will provide technical leadership for CAPA, deviations, investigations, change control, risk management, audits, and document control, interfacing with QA, Manufacturing, Engineering, Regulatory, and Supply Chain.

The role emphasizes continuous improvement, ALCOA+ records, and inspection readiness, overseeing annual

Qualifications

• Bachelor's degree in engineering, chemistry, biology, life sciences, or related technical discipline.
• Minimum 5 years of progressive experience in Quality Systems in a regulated industry.
• Experience with CAPA, deviations/nonconformances, investigations, change control, risk management, and audits.
• Experience cross-functional collaboration with Manufacturing, Engineering, QC, Validation, Regulatory, and QA.
• Experience interpreting ISO/FDA regulations and Quality Agreements.

Responsibilities

• Maintain and improve the site's QMS to meet regulatory requirements.
• Lead CAPA lifecycle and cross-functional investigations.
• Support internal and external audits and inspection readiness.
• Monitor KPIs for quality performance and trends.

Skills

CAPA handling

Investigations

Cross-functional collaboration

Audits

Quality metrics

Documentation control

Education

Bachelor's degree in engineering, Chemistry, Biology, Life Sciences, or related technical discipline

Job description

Aphena Pharma Solutions' Liquid and Topicals Division in Easton, MD seeks a Senior Quality Systems Engineer to lead the QMS within a highly regulated CMO/CDMO environment. You will provide technical leadership for CAPA, deviations, investigations, change control, risk management, audits, and document control, interfacing with QA, Manufacturing, Engineering, Regulatory, and Supply Chain.

The role emphasizes continuous improvement, ALCOA+ records, and inspection readiness, overseeing annual