Senior Compliance & Quality Systems Lead

SUN PHARMA; Billerica (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

SUN PHARMA is seeking an Associate, Compliance to oversee vendor management and ensure supplier quality compliance. The role provides scientific support for quality investigations (OOS, OOT, product quality complaints) and drives root cause analysis and timely closure of investigations under GLP, cGMP, and QMS standards.

The position involves managing and enhancing electronic quality systems (eQMS), including TrackWise, collaborating with cross-functional teams, and presenting quality metrics

Qualifications

• Oversee vendor SCARs and ensure effective follow-up.
• Support investigations including OOS/OOT and product quality complaints.
• Maintain and optimize electronic quality systems (eQMS) like TrackWise.

Responsibilities

• Review vendor SCARs and ensure timely closure.
• Ensure supplier products meet regulatory and quality standards.
• Develop strong vendor relationships and onboarding.
• Lead and support investigations for Product Quality Complaints.
• Prepare APQRs and present quality metrics.
• Analyze quality data and trends for continuous improvement.
• Manage TrackWise and other eQMS tooling.
• Coordinate cross-functional teams for QMS tasks.
• Drive QMS efficiency and compliance initiatives.
• Provide training on electronic quality systems.

Skills

Vendor management

QA investigations

TrackWise

Data analysis

Tools

TrackWise

eQMS

LMS

Job description

SUN PHARMA is seeking an Associate, Compliance to oversee vendor management and ensure supplier quality compliance. The role provides scientific support for quality investigations (OOS, OOT, product quality complaints) and drives root cause analysis and timely closure of investigations under GLP, cGMP, and QMS standards.

The position involves managing and enhancing electronic quality systems (eQMS), including TrackWise, collaborating with cross-functional teams, and presenting quality metrics