Senior cGMP Quality Leader, Pharma Manufacturing

Fresenius Medical Care; New York (NY); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid time off

Parental leave

Performance-based bonuses

Job summary

Fresenius Medical Care is seeking a Quality Manager, cGMP Pharmaceutical Products, to provide strategic and operational quality leadership across sites. You will partner with Manufacturing, Regulatory Affairs, Supply Chain, and R&D to maintain compliant product supply.

Ideal candidates have 10+ years in QA for pharma drug product manufacturing, deep knowledge of 21 CFR Parts 4, 210, 211 and ICH guidelines, and hands-on experience with regulatory inspections.

Qualifications

• Bachelor’s degree in chemistry, pharmaceutical sciences, chemical engineering, biology, or related field.
• Master’s degree or advanced technical degree preferred.

Responsibilities

• Lead and apply cGMP knowledge and training across sites.
• Participate in FDA inspections and regulatory audits.
• Ensure pharma/drug requirements are met at sites; guide process improvements.
• Assess quality issues via deviations, OOS, complaints, and audits.
• Provide inputs into Management Reviews and CAPA trends.

Skills

cGMP knowledge

FDA inspections

ICH guidelines

Quality leadership

CAPA management

eQMS platforms

SPC

QMS

Data integrity

Education

Bachelor’s degree in Chemistry

Master’s degree preferred

Tools

SAP

QMS

qTrack

Agile

Job description

Fresenius Medical Care is seeking a Quality Manager, cGMP Pharmaceutical Products, to provide strategic and operational quality leadership across sites. You will partner with Manufacturing, Regulatory Affairs, Supply Chain, and R&D to maintain compliant product supply.

Ideal candidates have 10+ years in QA for pharma drug product manufacturing, deep knowledge of 21 CFR Parts 4, 210, 211 and ICH guidelines, and hands-on experience with regulatory inspections.