GDP Incident & Deviation Coordinator

MSI Pharma; Indiana (PA); Hybrid; USD 90,000 - 120,000; Part time

Job summary

MSI Pharma is seeking an experienced GDP Incident & Deviation Coordinator to support quality and distribution operations in a regulated environment. You will manage deviations, temperature excursions, returns, investigations, and CAPAs while ensuring GDP compliance and contributing to continuous quality improvement across the supply chain.

The ideal candidate holds a Life Sciences or related degree and 5–7 years’ pharmaceutical experience, with strong analytical skills and the ability to

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Supply Chain, Quality, or related discipline.
• Minimum 5–7 years within the pharmaceutical industry.

Responsibilities

• Manage deviation, incident, return, and temperature excursion records within the Quality Management System (QMS).
• Act as the primary contact for distribution-related quality incidents and deviations.
• Coordinate investigations with internal stakeholders and third-party logistics providers (3PLs).
• Lead Root Cause Analysis (RCA) activities and support CAPA implementation.
• Collaborate with Quality, Operations, and Supply Chain teams to ensure timely deviation closure.
• Maintain accurate records within company systems and SharePoint.
• Participate in regular operational, quality, and business review meetings.

Skills

GDP knowledge

Quality mindset

Analytical skills

Problem solving

Attention to detail

Cross-functional collaboration

Continuous improvement

Education

Bachelor's degree in Life Sciences / Pharmacy / Quality / Supply Chain

Tools

Veeva QMS

SAP

SharePoint

Microsoft Office

Job description

Location: Hybrid

Engagement Status: Consultancy / Contract Opportunity

Overview

We are partnered with a leading pharmaceutical company seeking an experienced GDP Incident & Deviation Coordinator to support quality and distribution operations within a regulated environment. The successful candidate will manage deviations, temperature excursions, returns, investigations, and CAPAs while ensuring compliance with GDP requirements and supporting continuous quality improvement across the supply chain.

Requirements

• Manage deviation, incident, return, and temperature excursion records within the Quality Management System (QMS).
• Act as the primary contact for distribution-related quality incidents and deviations.
• Coordinate investigations with internal stakeholders and third-party logistics providers (3PLs).
• Lead Root Cause Analysis (RCA) activities and support CAPA implementation.
• Collaborate with Quality, Operations, and Supply Chain teams to ensure timely deviation closure.
• Maintain accurate records within company systems and SharePoint.
• Participate in regular operational, quality, and business review meetings.

Hard Skills

• Strong knowledge of Good Distribution Practice (GDP).
• Experience managing deviations, investigations, CAPAs, returns, and temperature excursions.
• Experience conducting Root Cause Analysis (RCA).
• Working knowledge of Veeva QMS, SAP, SharePoint, and Microsoft Office.
• Understanding of pharmaceutical distribution and 3PL operations.

Soft Skills

• Strong analytical and problem-solving skills.
• Excellent attention to detail and organisational abilities.
• Effective communication and stakeholder management skills.
• Ability to work collaboratively across cross-functional teams.
• Proactive approach to issue resolution and continuous improvement.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Supply Chain, Quality, or a related discipline.
• Minimum 5–7 years of experience within the pharmaceutical industry.