[Hiring] Senior cGMP Pharmaceutical Manager @Fresenius Medical Care

Role Description

The Quality Manager, cGMP Pharmaceutical Products is responsible for overseeing and supporting quality assurance responsibilities at pharmaceutical/drug manufacturing sites, ensuring full compliance with 21 CFR Parts 4, 210, 211, and applicable ICH guidelines for drug product manufacturing. This role provides cGMP strategic and operational quality leadership and guidance across systems and processes including:

• Batch disposition
• CAPA management
• Validation
• Supplier quality
• Regulatory inspections
• Management reviews

The Quality Manager provides solutions by partnering closely with Manufacturing, Regulatory Affairs, Supply Chain, and R&D to embed a culture of quality and ensure uninterrupted, compliant supply of pharmaceutical/drug products.

Qualifications

• 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
• 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 statistical process control (SPC), process capability analysis, and quality risk management (ICH Q9) is a plus
• Familiarity with FDA guidance documents on process validation, data integrity (21 CFR Part 11), and pharmaceutical quality systems is a plus
• Knowledge of EU GMP Annex requirements is advantageous for global supply programs is a plus
• Proficiency in eQMS platforms (e.g., SAP, QMS, qTrack, Agile etc)

Requirements

• Ability to work across time zones for North American multi-site coordination
• May require response to urgent regulatory or quality events outside of standard hours
• Travel up to 15% as required

Benefits

• Comprehensive benefits package including medical, dental, and vision insurance
• 401(k) with company match
• Paid time off
• Parental leave
• Potential for performance-based bonuses depending on company and individual performance

Company Description

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws. Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factors.