Senior Pharmaceutical Specialist

MSD; Haarlem; Hybrid; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Annual leave (≥35.5 days)

Travel expense reimbursement

Pension plan

On-site restaurant

On-site fitness facilities

Mental wellbeing support

Prayer and meditation room

Job summary

MSD in Haarlem seeks a Senior Pharmaceutical Specialist to provide expert guidance on pharmaceutical and technical topics related to device assembly, packaging processes, and technology transfers. You will advise leadership, help resolve complex quality issues, and ensure GMP, regulatory, and company standards are met while strengthening a culture of quality and collaboration.

You will participate in risk assessments, investigations, and continuous improvement initiatives, supporting audits and

Qualifications

• 3–5 years' experience in pharmaceutical manufacturing.
• GMP-regulated environment; ISO 13485 experience is a plus.
• Strong knowledge of QA, GMP, regulatory requirements, 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 cross-functional teams and leadership.

Responsibilities

• Advise 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 per GMP and regulatory requirements.
• Translate external guidelines into policies, procedures and working practices.
• Author, review and approve GMP documentation including process control, investigations, changes and VCP.
• Lead or contribute to resolution of complex technical and product quality issues via data review and trend analysis.
• Facilitate or lead Quality Risk Assessments with appropriate mitigation and controls.
• Monitor compliance within IPT/ Centre of Excellence and drive CAPAs.
• Support GMP inspections and ISO 13485 audits with site and global teams.
• Drive continuous improvement projects and change control activities in a regulated environment.
• Contribute to training programs and foster a high-performing team culture.

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

Education

Pharmacy degree

Pharmaceutical Sciences

Chemical Engineering background

Job description

Would you like to use your expertise to contribute to a healthier world? As part of our innovative team in Haarlem, you will work alongside colleagues to ensure the safe packaging and distribution of medicines and vaccines to more than 140 countries worldwide.

For our Centre of Excellence Quality team in Haarlem, we are looking for a Senior Pharmaceutical Specialist. Are you passionate about quality, collaboration, and continuous improvement? If so, we would love to hear from you.

Welcome to the team

At our pharmaceutical manufacturing site, quality, compliance, and scientific excellence are at the heart of everything we do. As part of the Centre of Excellence Quality, you will join a collaborative and quality-driven team that supports the site's core activities of device assembly, packaging operations, process improvements and technology transfers in a highly regulated GMP setting.

Your role

As Pharmaceutical Specialist, you provide expert guidance on pharmaceutical and technical topics related to device assembly, packaging processes, equipment, process changes and technology transfers. You advise IPT and Centre of Excellence leadership and teams, help resolve complex product quality issues and ensure that processes, documentation and risk assessments meet applicable GMP, regulatory and company standards. You will play an important role in maintaining process control, supporting inspections and audits, driving continuous improvement, and strengthening a culture of quality, compliance safety, and collaboration.

Primary 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.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemical Engineering or a related scientific or technical discipline.
• 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; experience with 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-performance, quality-focused culture.

What We Offer

• A competitive salary, based on your knowledge and experience.
• A 3% year-end payment and an annual bonus based on individual and company performance.
• At least 35.5 days of annual leave.
• Travel expense reimbursement and a solid pension plan.
• A high-quality company restaurant serving fresh and healthy meals daily.
• On-site sports facilities, including classes such as boxing, Zumba, and Pilates.
• Excellent coffee prepared by a professional barista.
• A large game room featuring darts, table football, a pool table, and table tennis.
• Mental wellbeing support through Lyra Health for both you and your family members.
• Access to a dedicated prayer and meditation room.

Required Skills

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

Employee Status: Regular

Flexible Work Arrangements: Hybrid