Quality Manager – Quality Assurance

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🔥 5 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 19%

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Foster a culture of quality within the Company organization and act as an ambassador for the QA department • Prepare, maintain, and execute internal and vendor Strategic and Annual Audit Programs • Lead the design, implementation, and management of internal and vendor audits • Lead corresponding quality risk management activities • Develop and maintain the internal Quality Risk Assessment methodology • Develop and maintain a comprehensive Audit Universe • Lead Quality Assurance activities related to procurement and vendor oversight • Develop, maintain, and manage mechanisms ensuring ongoing monitoring and compliance with applicable laws and regulations, including EU GVP, USFDA CFRs, JMPA, and ICH-E6 • Partner with Vendor Management and operations teams to drive risk-based and compliant audit strategy • Coordinate and contribute to internal system and vendor audits according to the Company Audit Plan • Manage pre-audit and post-audit activities • Conduct audits or coordinate audit documentation peer review and quality control activities within area of GxP expertise • Plan, coordinate, or conduct audits and provide GxP QA consultancy for client-contracted Quality as a Service activities • Monitor organizational compliance and assess impacts on audit strategy, audit plans, and execution

🎯 Requirements

• Bachelor’s or Master’s degree in biomedical sciences, natural sciences, health sciences, or another relevant scientific discipline, or an equivalent combination of advanced education and relevant industry experience • Experience with both GVP and GCP regulatory requirements, or willingness to broaden expertise • At least 3 years of direct auditing experience in GCP and/or GVP areas • At least 2 years of experience in audit program management, including development and maintenance of risk-based audit plans • Organization skills and attention to detail • Excellent communication and facilitation skills within a global organization • Proactive approach • Fluent in English

🏖️ Benefits

• Remote work option • Collaborative, international team • Career growth opportunities • Flexible work environment • Work-life balance • Opportunity to make an impact in clinical research, pharmacovigilance, and quality consulting

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