Senior cGMP Quality Manager – Pharma Compliance

Fresenius Medical Care; Dallas (TX); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Paid Time Off

Parental Leave

Performance Bonuses

Job summary

Fresenius Medical Care seeks a Quality Manager, cGMP Pharmaceutical Products to oversee QA at pharmaceutical manufacturing sites, ensuring full compliance with 21 CFR Parts 4, 210, 211 and ICH guidelines. You will lead CAPA, regulatory inspections, and site quality programs while partnering with Manufacturing, Regulatory Affairs, Supply Chain and R&D to embed a culture of quality.

The role requires 10+ years of QA experience in pharma and 5+ years in senior leadership, with hands-on FDA

Qualifications

• 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.
• Demonstrated experience leading Management Reviews and presenting to site and executive leadership.
• Familiarity with contract manufacturing organization (CMO) oversight is a plus.
• Deep expertise in 21 CFR Parts 4, 210 and 211.
• Strong working knowledge of ICH guidelines: Q7, Q8, Q9, Q10, Q11.
• Experience with SPC, process capability analysis, and quality risk management (ICH Q9) is a plus.

Responsibilities

• Leads and demonstrates cGMP knowledge and expertise including its application of cGMP requirements as well as training.
• Provides solutions and resolutions on how best to deploy systems and processes.
• Actively participates in FDA inspections and other regulatory audits.
• Actively engages and supports all pharma/drug sites to ensure cGMP requirements are met.
• Provides guidance on all pharma/drug related processes and system improvements and changes.
• Ensures by working with manufacturing sites and site quality personnel that all pharma/drug requirements are in place, procedures are compliant and being followed.
• Assesses effectiveness of pharma/drug requirements at sites.
• Provides inputs into Management Reviews in accordance with ICH Q10 and site QMS requirements.
• Maintains compliant, audit-ready Management Review records with appropriate retention.
• Analyzes product and process data trends to assess the state of control and identify improvement opportunities.

Skills

Quality Assurance

FDA inspections

cGMP knowledge

Leadership

CAPA management

Regulatory compliance

Analytical thinking

Cross-functional collaboration

Education

Bachelor's degree in chemistry, Pharmaceutical Sciences, Chemical Engineering, Biology, or related scientific discipline

Master's degree preferred

Tools

eQMS (SAP)

QMS

qTrack

Agile

Job description

Fresenius Medical Care seeks a Quality Manager, cGMP Pharmaceutical Products to oversee QA at pharmaceutical manufacturing sites, ensuring full compliance with 21 CFR Parts 4, 210, 211 and ICH guidelines. You will lead CAPA, regulatory inspections, and site quality programs while partnering with Manufacturing, Regulatory Affairs, Supply Chain and R&D to embed a culture of quality.

The role requires 10+ years of QA experience in pharma and 5+ years in senior leadership, with hands-on FDA