Quality Compliance Specialist II – GMP & QMS

SUN PHARMA; New Brunswick (NJ); On-site; USD 74,000 - 83,000; Full time

Job summary

Sun Pharma in New Jersey is seeking a highly motivated Compliance Associate II to strengthen our Quality Management System (QMS) and site compliance programs. This role ensures regulatory compliance, drives quality system effectiveness, and supports inspection readiness in a cGMP environment.

You will independently manage deviation management, change controls, and cleaning validation, while partnering with cross-functional teams to promote continuous improvement.

Qualifications

• Bachelor's degree required.
• Experience with Quality Management Systems (QMS) and quality event management.
• Strong knowledge of cGMP regulations and pharmaceutical compliance.

Responsibilities

• Independently manage and perform preliminary assessments for deviations within TrackWise.
• Independently review and manage change controls and facilitate CRB meetings.
• Monitor deviation and change control lifecycles to ensure timely investigations and closures.
• Collaborate with cross-functional teams to drive quality events to completion and maintain procedures.
• Ensure compliance with ALCOA+ data integrity principles across investigations and GMP records.
• Collect, analyze, trend, and report quality metrics related to deviations and change controls.
• Prepare quality summaries and presentations for QMRs and leadership meetings.
• Maintain and oversee the site's Cleaning Validation Program and CVMP.
• Support FDA and regulatory inspection readiness programs and audits.

Skills

Quality Management Systems

Deviation management

Change control

Data analysis

Cross-functional collaboration

ALCOA+ data integrity

Project management

Investigations

Communication

Education

Bachelor's degree

Tools

TrackWise

LMS

Microsoft Office

Data analysis tools

Job description

Sun Pharma in New Jersey is seeking a highly motivated Compliance Associate II to strengthen our Quality Management System (QMS) and site compliance programs. This role ensures regulatory compliance, drives quality system effectiveness, and supports inspection readiness in a cGMP environment.

You will independently manage deviation management, change controls, and cleaning validation, while partnering with cross-functional teams to promote continuous improvement.