Senior cGMP Pharmaceutical Manager

🔥 14 hours ago

🐊 Florida, Illinois, +6 more states – Remote

🐊 Florida – Remote 🌽 Illinois – Remote ⚜️ Louisiana – Remote 🗽 New York – Remote 🌲 North Carolina – Remote 🍂 Massachusetts – Remote ⚓ Rhode Island – Remote 🤠 Texas – Remote

⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Fresenius Medical Care

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1996

💼 Consulting

📦 Logistics

🏭 Manufacturing

💰 $6.1M Post-IPO Equity on 2020-02

Consulting • Logistics • Manufacturing

Fresenius Medical Care is a global health care company specializing in providing products and services for individuals with renal diseases. Founded in 1996, Fresenius Medical Care is the leading provider of dialysis treatment, building on the expertise of its parent company, the Fresenius health care group. The company is dedicated to improving the quality of life for patients worldwide by delivering high-quality care and innovative renal therapies. With a global presence, Fresenius Medical Care operates over 4,000 dialysis clinics and employs more than 125,000 people. The company's core values include collaboration, proactivity, reliability, and excellence, fostering a diverse and inclusive work environment to support its mission in delivering superior patient care.

📋 Description

• Oversee and support quality assurance responsibilities at pharmaceutical/drug manufacturing sites • Provide cGMP strategic and operational quality leadership and guidance across batch disposition, CAPA management, validation, supplier quality, regulatory inspections, management reviews, and related systems and processes • Partner with Manufacturing, Regulatory Affairs, Supply Chain, and R&D to embed a culture of quality and ensure uninterrupted, compliant supply • Lead and demonstrate cGMP knowledge and expertise, including training • Provide solutions and resolutions for deploying quality systems and processes • Participate in FDA inspections and other regulatory audits • Engage and support pharmaceutical/drug sites to ensure cGMP requirements are met • Guide pharmaceutical/drug-related processes and system improvements and changes • Work with manufacturing sites and site quality personnel to ensure requirements, compliant procedures, and adherence are in place • Assess effectiveness of pharmaceutical/drug requirements at sites • Provide independent input into in-process and finished product results, as appropriate • Analyze deviations, OOS results, complaints, and audit findings to identify systemic quality issues • Escalate critical quality issues to senior leadership and Regulatory Affairs • Provide input into Management Reviews in accordance with ICH Q10 and site QMS requirements • Compile and present Management Review data, including CAPA trends, deviation metrics, audit outcomes, product quality reviews, regulatory intelligence, and resource assessments • Maintain compliant, audit-ready Management Review records and use outcomes to drive continuous improvement and resource allocation • Analyze product and process data trends to assess state of control and identify improvement opportunities • Manage the change control program where appropriate • Serve as quality representative during FDA pre-approval, surveillance, and for-cause inspections • Prepare sites and personnel for regulatory inspections • Develop and manage responses to FDA Form 483 observations and Warning Letters with Regulatory Affairs • Perform other duties as assigned

🎯 Requirements

• 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 • Demonstrated experience leading Management Reviews and presenting to site and executive leadership • Deep expertise in 21 CFR Parts 4, 210 and 211 • Strong working knowledge of ICH guidelines: Q7, Q8, Q9, Q10, Q11 • Proficiency in eQMS platforms (e.g., SAP, QMS, qTrack, Agile etc.) • Familiarity with contract manufacturing organization (CMO) oversight is a plus • 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 • Ability to work across time zones for North American multi-site coordination • Ability to respond to urgent regulatory or quality events outside of standard hours • Travel up to 15% as required

🏖️ Benefits

• 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 • Reasonable accommodation for individuals with disabilities