QA Manager: Regulatory & Audit Readiness

LifeScience Logistics LLC.; Macungie (Lehigh County); On-site; USD 90,000 - 140,000; Full time

Job summary

LifeScience Logistics LLC. in the United States seeks a Regulatory Compliance and Quality leader to ensure FDA/cGMP/DSCSA compliance across threePL operations. You will drive inspection readiness and lead regulatory inspections and client audits, ensuring timely responses to observations and commitments.

You will oversee the QMS, including deviations, CAPA, change control, document control, GMP training, and investigations to sustain data integrity and product quality, with travel up to 15%.

Qualifications

• Minimum of 5 years of quality experience in FDA-regulated industry.
• Minimum of 3 years of supervisory experience.
• Working knowledge of federal/state laws governing warehousing and distribution of pharmaceuticals and medical devices.

Responsibilities

• Lead regulatory inspections and client audits with timely responses to observations.
• Support internal audit program and supplier/vendor qualifications.
• Oversee CAPA, deviations, change control, document control and training to maintain data integrity.

Skills

Analytical thinking

Communication skills

Leadership

Time management

Education

Bachelor's degree in Biology, Chemistry, Engineering

Tools

eQMS

LIMS

Tecsys Elite

WebCTRL

Outlook

Excel

Word

PowerPoint

Job description

LifeScience Logistics LLC. in the United States seeks a Regulatory Compliance and Quality leader to ensure FDA/cGMP/DSCSA compliance across threePL operations. You will drive inspection readiness and lead regulatory inspections and client audits, ensuring timely responses to observations and commitments.

You will oversee the QMS, including deviations, CAPA, change control, document control, GMP training, and investigations to sustain data integrity and product quality, with travel up to 15%.