Director, GCP/GVP QA & Inspection Readiness

SK Life Science; Paramus (NJ); On-site; USD 180,000 - 220,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, dental, and vision coverage

Job summary

SK Life Science is seeking a Director of Inspection Management/Quality Compliance to lead the end-to-end GCP/GVP QA strategy and inspection readiness. This role oversees a GCP QA team, drives risk-based audits, and ensures compliance with GCP/GVP regulations, SOPs and ICH guidelines across the organization.

The Director partners with Clinical Development, Regulatory Affairs, and CROs to resolve issues and drive continuous improvement.

Qualifications

• Bachelor's degree in healthcare or related field (Master's preferred).
• Minimum 15–20 years of pharmaceutical compliance and inspection management experience.

Responsibilities

• Establish and maintain the GCP/GVP Inspection Readiness program and policies.
• Oversee risk logging and cross-functional risk mitigation.
• Develop QA GCP/GVP strategy aligning with business needs.
• Lead Clinical Site Audits with CROs and Compliance QA.
• Assess new regulations and adjust internal processes and training.
• Coach QA team through regular touchpoints and reviews.
• Develop a GCP/GVP QA playbook for issue identification and training.
• Serve as change management agent for quality culture.

Skills

Leadership

Regulatory knowledge

GCP/GVP QA expertise

Cross-functional collaboration

Quality risk management

Training and coaching

Inspection readiness

Stakeholder communication

Education

Bachelor's degree in healthcare or related field

Master's degree preferred

Job description

SK Life Science is seeking a Director of Inspection Management/Quality Compliance to lead the end-to-end GCP/GVP QA strategy and inspection readiness. This role oversees a GCP QA team, drives risk-based audits, and ensures compliance with GCP/GVP regulations, SOPs and ICH guidelines across the organization.

The Director partners with Clinical Development, Regulatory Affairs, and CROs to resolve issues and drive continuous improvement.