Quality Assurance Specialist

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Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

At Merck, we are looking for a Quality Assurance Specialist & Technical Director in Ecuador to ensure technical‑regulatory and quality compliance across our local operations. This role is essential to guarantee adherence to GDP requirements and to represent the company before the health authority as the Responsible/Technical Representative.

Your role:

• Ensure full compliance with Good Distribution Practices (GDP) in Ecuador.
• Release products for commercialization and manage all related quality documentation.
• Analyze complaint and deviation trends, generating metrics and reports to ensure traceability and compliance.
• Support internal, external, and regulatory audits, aligning processes with Merck’s global standards (HCQ / Healthcare Operations).
• Implement, maintain, and continuously improve the Quality Management System, including updating SOPs and Work Instructions.
• Ensure accurate publication, control, and lifecycle management of documents in Mango.
• Act as the Responsible/Technical Representative before ARCSA, managing alerts, crises, notifications, and official communications.
• Support regulatory processes such as license renewals, maintenance of the regulatory archive, and post‑registration payments.
• Manage notifications and first‑lot releases, including biological products.
• Interact with health authorities, respond to technical requests, and accompany inspections and verifications.
• Support local pharmacovigilance activities by channeling notifications according to established procedures.
• Coordinate day‑to‑day activities with a quality analyst assigned as operational support.

Who you are:

• Chemist‑Pharmacist or Biochemist‑Pharmacist (mandatory requirement).
• Bring 4+ years of experience in similar roles within regulated quality environments, technical‑regulatory operations, or pharmaceutical compliance.
• Have strong knowledge of Ecuadorian regulations (GDP/GMP, ARCSA requirements) and experience interacting with health authorities.
• Possess conversational English, enabling effective communication with regional teams and review of global technical documentation.
• Demonstrate technical rigor, strong documentation skills, and the ability to operate with precision in highly regulated environments.
• Known for your responsibility, organization, clear communication, and capacity to manage critical processes independently.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!