Senior Pharmaceutical Specialist

Caraway Therapeutics, Inc.; Haarlem; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Year-end bonus

35.5 days annual leave

Travel expense reimbursement

Pension plan

On-site restaurant

Sports facilities

Wellbeing support

Prayer and meditation room

Job summary

Caraway Therapeutics, Inc. in Haarlem seeks a Senior Pharmaceutical Specialist to guide pharmaceutical and technical topics across device assembly, packaging processes, equipment, and technology transfers. You will collaborate with IPT, QA, and operations to ensure robust processes and compliant documentation.

You will drive continuous improvement, contribute to risk assessments, and support inspections and audits while maintaining a culture of quality and teamwork.

Qualifications

• 3–5 years experience in pharmaceutical manufacturing, preferably device assembly, packaging operations, equipment, process technology transfer or design transfer.
• Experience in GMP-regulated environments; ISO 13485 is a plus.
• Strong knowledge of QA, GMP compliance, regulatory requirements and quality mgmt systems.
• Ability to analyze complex technical and quality-related issues and translate findings into practical recommendations.

Responsibilities

• Advise leadership 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 and regulatory requirements.
• Evaluate external guidelines and translate them into pharmaceutical policies and practices.
• Author, review and approve GMP documentation including process control, investigations and change management.
• Lead or contribute to resolution of complex technical and product quality issues using data and trend analysis.
• Facilitate Quality Risk Assessments and implement risk mitigation and control measures.
• Support GMP inspections and ISO 13485 audits in collaboration with site and global functions.

Skills

Dutch language skills

Communication skills

Advisory skills

Collaborative mindset

Education

Bachelor's or Master's in Pharmacy or related

Job description

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.

If you are passionate about quality, collaboration, and continuous improvement 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.

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.

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