Director of GCP/GVP QA & Inspection Readiness

SK Life Science, Inc.; Paramus (NJ); On-site; USD 150,000 - 200,000; Full time

Job summary

SK Life Science, Inc. is seeking a Director of Inspection Management/Quality Compliance to lead the GCP/GVP QA strategy and oversee a quality assurance team in Paramus, New Jersey. The ideal candidate will have significant experience in pharmaceutical compliance, including managing end-to-end inspection readiness programs and conducting audits.

This role requires collaboration across functional teams to ensure compliance with regulations, development of training programs, and addressing audit findings. The position offers a senior-level opportunity for impactful leadership and strategic alignment of quality initiatives.

Qualifications

• Minimum 15 to 20 years of current pharmaceutical compliance experience required.
• Led end-to-end GCP/GVP inspection readiness programs.
• Served as primary moderator for regulatory inspections.

Responsibilities

• Establishes and maintains the GCP/GVP Inspection Readiness program.
• Develops QA GCP/GVP strategy for the team.
• Partners with Clinical Operations for audits.

Skills

Pharmaceutical compliance

Inspection Management

Risk management

Leadership

Regulatory compliance

Education

Bachelor’s degree in healthcare or a related field

Master’s degree preferred

Job description

SK Life Science, Inc. is seeking a Director of Inspection Management/Quality Compliance to lead the GCP/GVP QA strategy and oversee a quality assurance team in Paramus, New Jersey. The ideal candidate will have significant experience in pharmaceutical compliance, including managing end-to-end inspection readiness programs and conducting audits.

This role requires collaboration across functional teams to ensure compliance with regulations, development of training programs, and addressing audit findings. The position offers a senior-level opportunity for impactful leadership and strategic alignment of quality initiatives.