Senior cGMP Pharmaceutical Manager

🕒 Setembro 16

🐊 Florida, Illinois, +6 estados a mais – Remoto

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

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

🦅 Patrocina Visto H1B

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👻 Score fantasma 39%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Por que essa pontuação:

• Aberta há 57 dias.
• As vagas desta empresa costumam ser preenchidas em 21 dias.
• Repostada uma vez.
• Sem salário divulgado.

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Fresenius Medical Care

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1996

💼 Consultoria

📦 Logística

🏭 Manufatura

💰 $6.100.000 Post-IPO Equity em 2020-02

Consulting • Logistics • Manufacturing

A Fresenius Medical Care é uma empresa global de saúde especializada em fornecer produtos e serviços para pessoas com doenças renais. Fundada em 1996, a Fresenius Medical Care é a líder em tratamento de diálise, apoiando-se na expertise de sua controladora, o grupo de saúde Fresenius. A empresa é dedicada a melhorar a qualidade de vida de pacientes no mundo inteiro, oferecendo cuidado de alta qualidade e terapias renais inovadoras. Com presença global, a Fresenius Medical Care opera mais de 4. 000 clínicas de diálise e emprega mais de 125. 000 pessoas. Seus valores essenciais incluem colaboração, proatividade, confiabilidade e excelência, promovendo um ambiente de trabalho diverso e inclusivo para apoiar sua missão de oferecer atendimento superior ao paciente.

Descrição

• Oversee and support quality assurance responsibilities at pharmaceutical/drug manufacturing sites • Ensure compliance with 21 CFR Parts 4, 210, 211, and applicable ICH guidelines • Provide cGMP strategic and operational quality leadership and guidance • Lead quality systems and processes including batch disposition, CAPA management, validation, supplier quality, regulatory inspections, and management reviews • Partner with Manufacturing, Regulatory Affairs, Supply Chain, and R&D to embed a culture of quality • Lead and demonstrate cGMP knowledge and expertise, including training • Provide solutions for deploying quality systems and processes • Participate in FDA inspections and other regulatory audits • Support pharma/drug sites in meeting cGMP requirements • Guide pharma/drug-related processes, system improvements, and changes • Assess site requirements and effectiveness of quality systems • Provide independent input into in-process and finished product results • 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 under 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 • Use Management Review 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

🎯 Requisitos

• 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.) • 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 • 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

🏖️ Benefícios

• 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

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