PURPOSE AND SCOPE:

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 and others. 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.

PRINCIPAL DUTIES AND 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 independent inputs into in-process and finished product results, as appropriate.
• 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.
• Provides inputs into Management Reviews in accordance with ICH Q10 and site QMS requirements.
• Compiles and presents comprehensive Management Review input data including CAPA trends, deviation metrics, audit outcomes, product quality reviews, regulatory intelligence, and resource assessments.
• Maintains compliant, audit-ready Management Review records with appropriate retention. Use Management Review outcomes to drive continuous improvement priorities and resource allocation decisions.
• Analyzes product and process data trends to assess the state of control and identify improvement opportunities.
• Manages the change control program where appropriate.
• Serve as a quality representative during FDA pre-approval inspections (PAIs), surveillance inspections, and for-cause inspections.
• Prepare site and personnel for regulatory inspections. Develop and manage responses to FDA Form 483 observations and Warning Letters in collaboration with Regulatory Affairs.
• Other duties as assigned.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
• 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.

EDUCATION:

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

EXPERIENCE AND REQUIRED TECHNICAL SKILLS:         

• 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).

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.