GDP/GSP Quality Manager (Pharmaceutical)

Comrise; United States; Hybrid; USD 68,880 - 96,432; Part time

Benefits offered by this job

Flexible, part-time remote role

Opportunity to collaborate with global teams

Job summary

A leading quality management firm is seeking a GDP/GSP Quality Manager to support compliance and quality assurance in the U.S. market. This part-time remote position requires collaboration with cross-functional teams to ensure adherence to quality standards in pharmaceutical distribution. The ideal candidate will have over 5 years of experience in quality management and regulatory compliance, excellent stakeholder management skills, and the ability to work independently. Join a global team making impactful contributions to regulatory compliance and product quality.

Qualifications

• 5+ years of experience in pharmaceutical quality, preferably in GDP/GSP environments.
• Ability to work independently in a remote, part-time capacity.
• Strong understanding of pharmaceutical quality systems and compliance standards.

Responsibilities

• Ensure compliance with global QMS and applicable U.S. GDP/GSP regulations.
• Support inspection readiness activities, including FDA inspections.
• Partner with RA and 3PL teams to maintain quality standards.

Skills

Quality assurance systems

Inspection readiness and audits

Product complaints and incident management

Supply chain quality oversight

Stakeholder management

Cross-functional collaboration

Attention to detail

Microsoft Office proficiency

Education

Bachelor’s degree in Life Sciences, Pharmacy, or related field

Job description

GDP/GSP Quality Manager (Part-Time, Remote)

📍 Location: Remote (Must be available onsite in Princeton, NJ for regulatory inspections)

💰 Salary: $50-70 per hour (open and negotiable)

Overview

We are seeking a Local Quality Manager to support quality assurance and compliance activities within the U.S. market. This role is responsible for ensuring adherence to global Quality Management Systems (QMS) and local regulatory requirements, including GDP (Good Distribution Practice) and GSP (Good Storage Practice).

This is a hands‑on, part‑time role ideal for a quality professional experienced in pharmaceutical distribution and inspection readiness. You will collaborate cross‑functionally with Regulatory Affairs (RA), third‑party logistics (3PL) providers, and global quality teams to maintain compliance and minimize risk across the supply chain.

Key Responsibilities

Quality Systems & Compliance

• Ensure compliance with global QMS and applicable U.S. GDP/GSP regulations
• Support inspection readiness activities, including FDA and other regulatory inspections
• Partner with RA and 3PL teams to maintain quality standards across distribution operations
• Act as the primary local quality contact for global quality teams
• Monitor, assess, and mitigate quality and compliance risks within the supply chain
• Support quality event management, including deviations, complaints, and investigations
• Maintain accurate and compliant quality documentation and records

Operational Support

• Assist in implementing and improving local QMS processes
• Support quality audits, self‑inspections, and supplier quality oversight
• Contribute to quality reporting activities (e.g., annual reports, metrics, trends)
• Ensure effective communication and escalation of quality issues

Quality Strategy & Collaboration

• Support continuous improvement, simplification, and harmonization of QMS processes
• Act as a liaison between global quality teams and U.S. regulatory requirements
• Participate in regulatory inspection preparation and execution
• Collaborate cross‑functionally to strengthen compliance and operational efficiency

Qualifications

Education

• Bachelor’s degree (or higher) in Life Sciences, Pharmacy, or related field

Experience

• Minimum 5+ years of experience in pharmaceutical quality, preferably in GDP/GSP environments
• Strong background in: Quality assurance systems, Inspection readiness and audits, Product complaints and incident management, Supply chain quality oversight, and Experience working with U.S. regulatory requirements
• Strong understanding of pharmaceutical quality systems and compliance standards
• Ability to work independently in a remote, part‑time capacity
• Excellent stakeholder management and cross‑functional collaboration skills
• High attention to detail and strong documentation practices
• Ability to manage multiple priorities in a fast‑paced environment
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook)

Why Join

• Flexible, part‑time remote role
• High‑impact position supporting regulatory compliance and product quality
• Opportunity to collaborate with global teams in a growing organization