Senior QA Leader, cGMP Pharma Compliance

Fresenius Medical Care AG; Waltham (MA); Presencial; USD 140.000 - 170.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid time off

Parental leave

Bonus potential

Descripción de la vacante

Fresenius Medical Care seeks a Quality Manager, cGMP Pharmaceutical Products, to lead QA across drug manufacturing sites and ensure compliance with 21 CFR Parts 4, 210, 211 and ICH guidelines.

The role partners with Manufacturing, Regulatory Affairs, Supply Chain, and R&D to embed a culture of quality, oversee CAPA, validation, supplier quality, and regulatory inspections, and drive continuous improvement in product quality and process controls.

Formación

• Bachelor’s degree in chemistry, Pharmaceutical Sciences, Chemical Engineering, Biology, or related scientific discipline (required). Master’s degree or advanced technical degree preferred.
• 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.

Responsabilidades

• Leads and demonstrates cGMP knowledge and expertise including its application of cGMP requirements as well as training.
• Provides solutions on how best to deploy systems and processes.
• Actively participates in FDA inspections and other regulatory audits.
• Supports all pharma/drug sites to ensure cGMP requirements are met and procedures are compliant.
• Performs analysis of deviations, OOS results, complaints, and audit findings to identify systemic quality issues.
• Escalates critical quality issues to senior leadership and regulatory affairs in a timely manner.
• Compiles Management Review data including CAPA trends, deviation metrics, audit outcomes, and product quality reviews.
• Maintains compliant, audit-ready Management Review records with retention.

Conocimientos

cGMP knowledge

FDA inspections

CAPA management

Management Reviews

ICH Q7-Q11

Data integrity

QMS familiarity

SPC / SPC analytics

Educación

Bachelor’s degree (Chemistry/Pharma/Biology)

Master’s degree preferred

Herramientas

SAP

QMS

qTrack

Agile

Descripción del empleo

Fresenius Medical Care seeks a Quality Manager, cGMP Pharmaceutical Products, to lead QA across drug manufacturing sites and ensure compliance with 21 CFR Parts 4, 210, 211 and ICH guidelines.

The role partners with Manufacturing, Regulatory Affairs, Supply Chain, and R&D to embed a culture of quality, oversee CAPA, validation, supplier quality, and regulatory inspections, and drive continuous improvement in product quality and process controls.