Senior GMP/GDP Expert — Clinical Distribution Lead

Msd; Nederland; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

3% year-end bonus

Annual bonus based on performance

35.5 days annual leave

Travel allowance

Company restaurant and wellness perks

On-site facilities: gym, game room, k?

Job summary

MSD in Haarlem is building a state-of-the-art, highly automated EU Clinical Distribution hub. The Senior Pharmaceutical Specialist will ensure GMP/GDP compliance across receipt, storage, handling, picking, packing and shipment of Clinical Supplies, and will translate quality requirements into practical solutions for daily operations.

You will coach colleagues, lead risk-based investigations, and drive CAPA and continuous improvement activities, in a hybrid work setting with close collaboration

Qualifications

• HBO/WO degree in a relevant field (pharmacy, life sciences, quality, supply chain or similar).
• Extensive experience in pharma/clinical supply, quality or logistics with GMP/GDP knowledge.
• Ability to translate quality requirements into practical operational solutions and guide teams.

Responsibilities

• Act as GMP/GDP expert for Clinical Distribution and support Operations on quality issues.
• Assess deviations/changes for impact on product quality and compliance.
• Translate external guidelines into practical processes, procedures, and work instructions.
• Review and authorize GMP/GDP documentation within the area of responsibility.
• Coach team members and support CAPA, Deviation Management and Change Control.
• Lead quality risk assessments and follow up on temperature excursions and other quality events.
• Support audits and inspections, including preparation and follow-up of findings.
• Drive continuous improvement of processes, systems, and ways of working.

Skills

CAPA Management

Clinical Supply Chain

Continuous Improvement

Deviation Management

GMP Compliance

GDP

Pharmaceutical Quality Assurance

Quality Standards

Regulatory Compliance

Risk Management

Root Cause Analysis

Self Motivation

Education

HBO/WO degree in pharmacy, life sciences, quality, supply chain or similar

Job description

MSD in Haarlem is building a state-of-the-art, highly automated EU Clinical Distribution hub. The Senior Pharmaceutical Specialist will ensure GMP/GDP compliance across receipt, storage, handling, picking, packing and shipment of Clinical Supplies, and will translate quality requirements into practical solutions for daily operations.

You will coach colleagues, lead risk-based investigations, and drive CAPA and continuous improvement activities, in a hybrid work setting with close collaboration