Senior cGMP Quality Leader – Pharma, 401(k) & PTO

Fresenius Medical Care; Waltham (MA); On-site; USD 130,000 - 190,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid time off and parental leave

Job summary

Fresenius Medical Care seeks a Quality Manager for cGMP Pharmaceutical Products to guide QA leadership across sites, ensuring compliance with 21 CFR parts and ICH guidelines. The role partners with Manufacturing, Regulatory Affairs, Supply Chain, and R&D to embed a culture of quality and uninterrupted supply of drug products.

The ideal candidate has 10+ years in QA with leadership experience, hands-on FDA inspection expertise, and strong CAPA/Management Review skills.

Qualifications

• Bachelor’s degree in chemistry, Pharmaceutical Sciences, Chemical Engineering, Biology, or related scientific discipline (required).
• 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 responsibility.
• Hands-on experience with FDA inspections including Form 483 responses and remediation.

Responsibilities

• Oversee and support QA responsibilities at pharmaceutical/drug manufacturing sites.
• Lead cGMP knowledge deployment and training.
• Participate in FDA inspections and regulatory audits.
• Engage sites to ensure cGMP requirements are met and procedures are followed.
• Provide input into Management Reviews and CAPA trends.
• Maintain audit-ready Management Review records and drive continuous improvement.
• Prepare responses to FDA 483 observations in collaboration with Regulatory Affairs.

Skills

QA leadership

FDA inspections

CAPA management

ICH guidelines

quality systems

Education

Bachelor’s degree (chemistry/Pharma Sci/related)

Master’s degree preferred

Tools

SAP

QMS

qTrack

Agile

Job description

Fresenius Medical Care seeks a Quality Manager for cGMP Pharmaceutical Products to guide QA leadership across sites, ensuring compliance with 21 CFR parts and ICH guidelines. The role partners with Manufacturing, Regulatory Affairs, Supply Chain, and R&D to embed a culture of quality and uninterrupted supply of drug products.

The ideal candidate has 10+ years in QA with leadership experience, hands-on FDA inspection expertise, and strong CAPA/Management Review skills.