Senior Pharmaceutical Specialist - Quality & GMP Lead

MSD Netherlands; Haarlem; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

35.5 days leave

Pension plan

On-site restaurant

On-site sports facilities

Wellbeing support

Job summary

MSD Netherlands in Haarlem seeks a Senior Pharmaceutical Specialist to guide device assembly, packaging, and technology transfers within a GMP framework. You will advise leadership and cross-functional teams to maintain product quality and robust processes, driving improvements and ensuring regulatory alignment.

With 3–5 years in pharma manufacturing and strong QA/GMP knowledge, you’ll collaborate across production, quality, and operations, while fostering a culture of continuous improvement and

Qualifications

• Bachelor’s or Master’s degree in Pharmacy or related field.
• 3–5 years' experience in pharmaceutical manufacturing, preferably within device assembly, packaging operations, equipment, process technology transfer or design transfer.
• Experience working in a GMP-regulated environment; ISO 13485 is considered an advantage.
• Strong knowledge of quality assurance, GMP compliance, regulatory requirements, industry standards and quality management systems.
• Experience with technical investigations, change control, quality risk assessments and continuous improvement initiatives.
• Ability to analyze complex technical and quality-related issues and translate findings into practical recommendations.
• Strong communication and advisory skills, with the ability to engage effectively with cross-functional teams and leadership.
• Conversational Dutch language skills.
• Collaborative mindset with the ability to motivate others and contribute to a high-performing, quality-focused culture.

Responsibilities

• Advise IPT and Centre of Excellence leadership and 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 requirements, industry standards and company procedures.
• Evaluate external guidelines and translate them into relevant pharmaceutical policies, procedures and working practices.
• Author, review and approve GMP documentation, including documentation related to process control, investigations, changes and continuous process verification.
• Lead or contribute to the resolution of complex technical and product quality issues, using pharmaceutical expertise, data review and trend analysis.
• Facilitate, lead or participate in Quality Risk Assessments and ensure appropriate risk mitigation and control measures are implemented.
• Monitor compliance within the IPT or Centre of Excellence and initiate corrective and preventive actions where needed.
• Support GMP inspections and ISO 13485 audits in collaboration with other site and global functions.
• Drive continuous improvement initiatives, technical projects and change control activities in a regulated environment.
• Contribute to training program development and help foster a high-performing, quality-focused and collaborative team culture.

Skills

Pharmaceutical expertise

Quality assurance

GMP compliance

Regulatory knowledge

Change management

Advisory skills

Dutch language

Education

Bachelor’s or Master’s degree in Pharmacy or related field

Pharmaceutical Sciences

Job description

MSD Netherlands in Haarlem seeks a Senior Pharmaceutical Specialist to guide device assembly, packaging, and technology transfers within a GMP framework. You will advise leadership and cross-functional teams to maintain product quality and robust processes, driving improvements and ensuring regulatory alignment.

With 3–5 years in pharma manufacturing and strong QA/GMP knowledge, you’ll collaborate across production, quality, and operations, while fostering a culture of continuous improvement and