Senior GCP QA Lead: Clinical Quality & Audits

SUN PHARMA; Princeton (NJ); On-site; USD 151,000 - 184,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k) savings plan

Paid time off

Job summary

SUN PHARMA in Princeton, NJ seeks a Sr Manager, GCP Quality Assurance (Asset Lead) to provide strategic quality oversight for development programs within GDO Branded Portfolio. Acts as primary QA asset representative to global project teams, ensuring compliance with GXP regulations and risk-based quality management across the clinical lifecycle.

This role leads quality risk assessments, supports inspection readiness, and guides audits of sites, CROs, vendors, and systems.

Qualifications

• BS degree in chemistry, biology or related field; advanced degree preferred.
• Demonstrated expertise in ICH-GCP, FDA, EMA, ISO and global regulatory requirements.
• Experience supporting regulatory inspections and inspection readiness programs.
• Experience providing quality oversight to Phase I-IV clinical development programs.

Responsibilities

• Serve as the primary Quality representative for assigned assets/programs.
• Provide quality risk assessments and strategic recommendations to asset teams.
• Represent QA on clinical and non-clinical teams to ensure regulatory compliance and data integrity.
• Plan, conduct, and report GCP audits of sites, CROs, vendors, and processes.
• Create and execute audit plans ensuring compliance with regulations and SOPs.
• Travel 20% domestically and internationally to conduct audits onsite.

Skills

Quality assurance

GxP regulations

Auditing

Education

BS Degree in Chemistry/Biology or related

Job description

SUN PHARMA in Princeton, NJ seeks a Sr Manager, GCP Quality Assurance (Asset Lead) to provide strategic quality oversight for development programs within GDO Branded Portfolio. Acts as primary QA asset representative to global project teams, ensuring compliance with GXP regulations and risk-based quality management across the clinical lifecycle.

This role leads quality risk assessments, supports inspection readiness, and guides audits of sites, CROs, vendors, and systems.