Senior Compliance & Quality Systems Lead

SUN PHARMA; Billerica (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

SUN PHARMA in Billerica, MA seeks a Sr. Associate, Compliance to oversee vendor management and supplier quality compliance. The role supports quality investigations (OOS, OOT, PQCs), drives root cause analysis, ensures timely closures, and maintains QMS standards across eQMS platforms like TrackWise.

Responsibilities include APQR preparation, data trending, and presenting quality metrics to leadership, with a focus on continuous improvement and regulatory adherence.

Qualifications

• Experience in vendor management and supplier quality systems.
• Strong knowledge of GLP, cGMP and QMS standards.
• Experience preparing APQRs and quality metrics reports.

Responsibilities

• Review and manage vendor SCARs and ensure effective follow-up.
• Ensure vendor-supplied products meet regulatory and quality standards.
• Develop strong relationships with approved vendors and evaluate new capabilities.
• Lead investigations including OOS/OOT and product quality complaints with root cause analysis.
• Prepare APQRs and present quality metrics at reviews to drive improvements.

Skills

Vendor management

Quality investigations

Data analysis

Communication

Tools

TrackWise

Job description

SUN PHARMA in Billerica, MA seeks a Sr. Associate, Compliance to oversee vendor management and supplier quality compliance. The role supports quality investigations (OOS, OOT, PQCs), drives root cause analysis, ensures timely closures, and maintains QMS standards across eQMS platforms like TrackWise.

Responsibilities include APQR preparation, data trending, and presenting quality metrics to leadership, with a focus on continuous improvement and regulatory adherence.