Sr. QA Specialist

Tjoapack; Etten-Leur; Remote; EUR 70,000 - 100,000; Full time

Benefits offered by this job

30 vacation days

Pension scheme

Annual salary increases

Job summary

Alcami is a leading global CDMO with a site in Etten-Leur, focusing on pharmaceutical packaging and supply chain services. We are seeking a Senior Quality Assurance Specialist to safeguard product quality, patient safety and regulatory compliance.

You will support QA activities, interact with regulatory authorities, customers and suppliers, and drive continuous improvement across the quality management system.

Qualifications

• Master's degree in a pharmaceutical-related subject or a Bachelor’s with sufficient QA experience.
• Experience working in GMP/GDP-regulated pharmaceutical environments.
• Audits, inspections, quality systems, CAPAs, deviations and root cause analysis experience.
• Experience managing supplier and customer relationships while maintaining regulatory requirements.
• Strong analytical, organizational and problem-solving skills.

Responsibilities

• Plan, coordinate and execute supplier qualification and supplier audits.
• Prepare and coordinate Quality Technical Agreements with customers and suppliers.
• Manage customer audits and regulatory inspections, including observations follow-up.
• Review and approve QA activities such as procedures, deviations, CAPAs and change controls.
• Coordinate external stability studies from protocol to results.
• Collaborate with customers, suppliers, laboratories and internal teams to resolve quality issues.
• Provide quality and regulatory guidance to cross-functional teams.

Skills

Regulatory knowledge

Quality Assurance

Stakeholder management

GMP/GDP experience

Education

Master's degree in pharmaceutical field

Bachelor's + relevant QA experience

Job description

Build the quality standards that help deliver life-saving medicines. Alcami is a leading global Contract Development and Manufacturing Organization (CDMO), providing integrated solutions to the pharmaceutical and biotechnology industries. We support our customers across the pharmaceutical lifecycle with a shared purpose: helping bring important medicines to patients safely, reliably and efficiently. At our site in Etten-Leur, we specialize in pharmaceutical packaging and supply chain services. With decades of experience in the pharmaceutical industry, we help ensure that medicines are packaged safely, meet the highest quality standards and reach patients around the world. As a Senior Quality Assurance Specialist, you will play a key role in safeguarding product quality, patient safety and regulatory compliance across our Etten-Leur site. You will provide expert Quality Assurance support and work closely with colleagues, customers, suppliers, external laboratories and regulatory authorities. If you enjoy working in a highly regulated environment, taking ownership of complex quality activities and finding practical solutions to quality and compliance challenges, this could be your next career move.

What You'll Do

In this role, you will independently plan, coordinate and execute a broad range of Quality Assurance activities. You will act as a key point of contact for internal and external stakeholders and contribute to maintaining and continuously improving our Quality Management System.

Your responsibilities include:

• Planning, coordinating and executing supplier qualification and supplier audits.
• Preparing, negotiating and coordinating Quality Technical Agreements with customers and suppliers.
• Managing customer audits and regulatory inspections, including preparation, hosting and follow-up of observations and commitments.
• Reviewing, approving and, where required, executing Quality Assurance activities such as procedures, deviations, CAPAs, change controls and effectiveness checks.
• Coordinating external stability studies from protocol preparation through to results and follow-up.
• Working closely with customers, suppliers, laboratories and internal teams to resolve quality-related issues and ensure timely communication.
• Providing quality and regulatory guidance to colleagues and cross-functional teams.
• Identifying opportunities for continuous improvement and contributing to a strong quality and compliance culture.

What You’ll Bring

We're looking for an experienced Quality professional who combines strong pharmaceutical and regulatory knowledge with excellent communication and stakeholder management skills.

• A Master's degree or equivalent in a pharmaceutical-related subject. A Bachelor's degree with sufficient relevant professional experience in pharmaceutical Quality Assurance will also be considered.
• Experience working within a GMP/GDP-regulated pharmaceutical environment.
• Demonstrable experience with audits, inspections, quality systems, CAPAs, deviations and root cause analysis.
• Experience managing supplier and customer relationships and expectations while maintaining quality and regulatory requirements.
• Strong analytical, organizational and problem-solving skills.
• Excellent communication skills and the ability to explain complex quality and regulatory topics clearly.
• A pragmatic and solution-oriented approach, with the ability to balance customer requirements, operational needs and regulatory compliance.
• The ability to work independently, take ownership and manage multiple priorities in a fast-paced environment.
• Full professional proficiency in English. Professional Dutch proficiency is an advantage.

What We Offer

At Alcami, you'll join an international organization where quality, collaboration and continuous improvement go hand in hand. You will have the opportunity to work with experienced colleagues across the organization and contribute directly to the quality of medicines reaching patients.

You can expect:

• A challenging and impactful senior role within a growing global pharmaceutical organization.
• Opportunities for personal and professional development.
• An international and collaborative working environment.
• A culture where ownership, continuous improvement and teamwork are encouraged.
• 30 vacation days.
• An attractive pension scheme.
• Annual salary increases based on performance.
• A competitive salary and excellent secondary employment conditions.

Why Alcami?

At Alcami, every role contributes to one shared purpose: improving patients' lives. As a Senior Quality Assurance Specialist, your expertise will directly contribute to ensuring that medicines are packaged safely, reliably and in compliance with the highest quality and regulatory standards. If you're looking for a role where your Quality expertise can make a real impact, we'd love to hear from you.