Senior Pharmaceutical Specialist

MSD Malaysia; Haarlem; On-site; EUR 75,000 - 105,000; Full time

Benefits offered by this job

3% year-end bonus

Annual leave 35.5 days

Travel expense reimbursement

Pension plan

On-site restaurant

On-site sports facilities

Quality-focused culture

Lyra Health wellbeing

Job summary

Merck & Co., Inc., Rahway, NJ, USA (Merck Sharp & Dohme LLC) in Haarlem seeks a Senior Pharmaceutical Specialist to guide device assembly, packaging processes and technology transfers under GMP in a highly regulated environment.

You will partner with production, quality, technical operations and global teams to manage product quality risks, drive investigations, change controls and continuous improvement while ensuring compliance with regulatory standards and company policies.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemical Engineering or related.
• 3–5 years' experience in pharmaceutical manufacturing, preferably device assembly/packaging/tech transfer.
• GMP-regulated environment experience; ISO 13485 is advantageous.
• Strong knowledge of QA, GMP compliance, regulatory requirements, 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.
• Conversational Dutch language skills and ability to engage cross-functionally.

Responsibilities

• Advise IPT and Centre of Excellence leadership on pharmaceutical and technical topics.
• Identify, assess and manage product quality risks in line with GMP and regulatory requirements.
• Translate external guidelines into relevant pharmaceutical policies and procedures.
• Author, review and approve GMP documentation including process control, investigations and changes.
• Lead or contribute to the resolution of complex technical and product quality issues using expertise and data analysis.
• Facilitate or participate in Quality Risk Assessments with mitigations.
• Support GMP inspections and ISO 13485 audits with cross-functional collaboration.
• Drive continuous improvement initiatives and change control activities in a regulated environment.
• Contribute to training programs and foster a quality-focused culture.

Skills

GMP compliance

Quality assurance

Change management

Investigation & analysis

Cross-functional collaboration

Dutch language

Strong communication

Education

Bachelor’s or Master’s in Pharmacy, Pharmaceutical Sciences, Chemical Engineering or related

Job description

Senior Pharmaceutical Specialist

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.

We are looking for a Pharmaceutical Specialist who combines strong technical expertise with a practical, solution-oriented mindset. In this role, you will work closely with production, quality, technical operations and local and global cross‑functional stakeholders to ensure that product quality risks are effectively managed and that our processes remain compliant, robust and continuously improving.

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.

Required Skills

• cGMP Regulations
• Change Controls
• Change Management
• Deviation Management
• Manufacturing Quality Control
• Pharmaceutical Quality Assurance
• Product Disposition
• Quality Auditing

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.

If you're not sure whether you meet every requirement for the role, we still encourage you to apply. We value motivation, learning agility, and collaboration, and we would be happy to explore together what you can bring to the team.

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA.

Employment Terms

• Employee Status: Regular
• Relocation:
• VISA Sponsorship:
• Travel Requirements:
• Flexible Work Arrangements:
• Hybrid Shift:
• Valid Driving License:
• Hazardous Material(s):
• Job Posting End Date: 10/31/2026