Remote Senior cGMP Quality Manager (Pharma)

Fresenius Medical Care AG; Texas; On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with company match

Paid time off

Parental leave

Job summary

Fresenius Medical Care AG is seeking a Sr cGMP Pharmaceutical Manager to lead quality assurance for drug product manufacturing, ensuring strict compliance with 21 CFR parts and ICH guidelines. The role partners with Manufacturing, Regulatory Affairs, and R&D to embed a culture of quality and uninterrupted supply.

The position requires a strong background in cGMP, FDA inspections, CAPA, and process improvement, with 10+ years of QA experience and 5+ years in leadership.

Qualifications

• Bachelor’s degree in chemistry, pharmaceutical sciences, chemical engineering, biology, or a related field.
• Minimum 10+ years of quality assurance experience in pharmaceutical drug product manufacturing.
• Minimum 5+ years in a senior QA leadership role with direct people management responsibilities.
• Hands-on experience with FDA inspections including Form 483 responses and remediation.
• Deep knowledge of 21 CFR Parts 4, 210, 211 and ICH guidelines Q7–Q11.

Responsibilities

• Lead and oversee quality assurance responsibilities across pharmaceutical sites to ensure compliance.
• Participate in regulatory inspections and coordinate responses to 483 observations.
• Manage CAPA programs, deviations, investigations, and product quality reviews.
• Provide QA leadership in change control, supplier quality, and management reviews.
• Collaborate with Manufacturing, Regulatory Affairs, Supply Chain and R&D.

Skills

Quality leadership

FDA inspections

CAPA management

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor’s degree in chemistry, Pharmaceutical Sciences, Chemical Engineering, Biology

Master’s degree preferred

Tools

eQMS

SAP

QMS

qTrack

Agile

Job description

Fresenius Medical Care AG is seeking a Sr cGMP Pharmaceutical Manager to lead quality assurance for drug product manufacturing, ensuring strict compliance with 21 CFR parts and ICH guidelines. The role partners with Manufacturing, Regulatory Affairs, and R&D to embed a culture of quality and uninterrupted supply.

The position requires a strong background in cGMP, FDA inspections, CAPA, and process improvement, with 10+ years of QA experience and 5+ years in leadership.