Senior Pharmaceutical Specialist

About the role

Join MSD's Centre of Excellence Quality in Haarlem to ensure safe packaging and distribution of medicines and vaccines to over 140 countries. As a Senior Pharmaceutical Specialist you will work closely with production, quality, and technical teams in a highly regulated GMP environment.

Key responsibilities

• Advise cross‑functional teams on pharmaceutical and technical aspects of device assembly, packaging equipment, process changes and technology transfers.
• Identify, assess and manage product quality risks in line with GMP, regulatory and company standards.
• Author, review and approve GMP documentation, including process control, investigations, changes and continuous verification.
• Lead or support resolution of complex technical and product quality issues using data analysis and trend evaluation.
• Facilitate Quality Risk Assessments and ensure implementation of appropriate mitigation measures.
• Support GMP inspections and ISO 13485 audits, and drive continuous‑improvement projects.

Required profile

• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemical Engineering or related field.
• 3–5 years of experience in pharmaceutical manufacturing, preferably in device assembly or packaging operations.
• Experience working in a GMP‑regulated environment; ISO 13485 knowledge is a plus.
• Strong knowledge of quality assurance, regulatory requirements and quality management systems.
• Excellent communication and advisory skills with ability to engage cross‑functional teams.
• Conversational Dutch language skills.

Required skills

• cGMP Regulations
• Change Controls
• Change Management
• Deviation Management
• Manufacturing Quality Control
• Pharmaceutical Quality Assurance
• Product Disposition
• Quality Auditing
• Quality Management Standards
• Regulatory Compliance
• Risk Management
• Strategic Planning

What we offer

• Competitive salary with a 3% year‑end payment and performance bonus.
• At least 35.5 days of annual leave.
• Travel expense reimbursement and solid pension plan.
• Company restaurant with fresh meals, on‑site sports facilities, and a game room.
• Mental wellbeing support through Lyra Health for employees and families.
• Dedicated prayer and meditation room.