Quality Compliance Coordinator - Vendor & eQMS Specialist

SUN PHARMA; Billerica (MA); Presencial; USD 85.000 - 105.000; Jornada completa

Descripción de la vacante

Responsibilities include APQR preparation, presenting quality metrics, data trends, and risk assessments to support continuous improvement and informed decision-making. The ideal candidate supports cross-functional teams and helps implement electronic quality systems while maintaining strong vendor relationships.

Formación

• Experience leading vendor management programs and supplier quality oversight.
• Ability to perform root cause analysis for investigations (OOS/OOT and product quality complaints).
• Comfort with quality data analysis and risk assessment to support continuous improvement.

Responsabilidades

• Review and manage Vendor SCARs with effective follow-up and closure.
• Ensure vendor-supplied products meet regulatory and quality standards.
• Develop and maintain relationships with approved vendors and conduct onboarding interviews.
• Lead investigations for Stage II OOS/OOT and product quality issues with cross-functional teams.
• Prepare APQRs and present quality metrics and risk assessments to QA leadership.
• Manage TrackWise and drive eQMS/EDMS/LMS implementations and improvements.
• Prepare monthly QRB materials and present findings on quality investigations.
• Draft and revise SOPs and test methods; support timely closure of QA documents.

Conocimientos

Vendor management

Quality investigations

APQRs

QMS

GLP/cGMP

Herramientas

TrackWise

Descripción del empleo

Responsibilities include APQR preparation, presenting quality metrics, data trends, and risk assessments to support continuous improvement and informed decision-making. The ideal candidate supports cross-functional teams and helps implement electronic quality systems while maintaining strong vendor relationships.