Quality Manager – Quality Assurance

ERGOMED

. Foster a culture of quality within the Company organization and act as an ambassador for the QA department .

Posted 11/3/2026full-timeRemote • IndiaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance and Audit Management, with a strong focus on GxP compliance and regulatory requirements. Proficient in developing and executing audit programs while fostering a culture of quality within the organization.

Highest-signal resume keywords

GCP AND GVP Regulatory RequirementsAudit Program ManagementQuality Risk Assessment MethodologyInternal And Vendor AuditsExcellent Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Auditing ExperienceRisk-Based Audit PlansQuality Assurance ActivitiesCompliance MonitoringAudit DocumentationGxP ExpertiseStrategic Audit ProgramsVendor OversightQuality Risk ManagementAudit Universe Development

Soft Skills

Organization SkillsAttention To DetailProactive ApproachFacilitation Skills

Industry Keywords

EU GVPUSFDA CFRsJMPAICH-E6Biomedical SciencesNatural SciencesHealth Sciences

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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