Work Your Magic with us!
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.
Location: Cuautitlán Izcalli
Your Role:
We are seeking a dedicated and detail-oriented Quality Specialist to join our team, reporting directly to the Quality Manager. This position plays a critical role in ensuring compliance with national health regulations and internal quality standards, particularly aligning with COFEPRIS requirements (NOM-059, NOM-072, NOM-240, NOM-241), as well as international GMP and GDP guidelines. The successful candidate will support audit readiness and contribute actively to regulatory inspections and internal continuous improvement initiatives.
Key responsibilities include managing quality events such as deviations, CAPAs, complaints, change controls, and product alerts to ensure timely resolution and regulatory compliance. The Quality Specialist will be responsible for maintaining and improving the Quality Management System (QMS), leveraging tools such as TrackWise, SAP, and Power BI to ensure data integrity, process transparency, and performance tracking.
This role also oversees quality assurance for warehouse and logistics operations, including inspections, calibration activities, relabeling, and verification of storage conditions to meet compliance standards. Additionally, the candidate will coordinate product release, manage product returns, and support product lifecycle and documentation management.
Support for equipment and cold chain validation activities is required, as well as collaboration with pharmacovigilance teams to ensure timely and accurate safety reporting. The Quality Specialist will also be involved in auditing suppliers and clients to confirm GxP adherence, delivering training sessions on GxP practices, and contributing to crisis management and product recall processes as needed. This is a strategic and hands-on role that ensures our quality systems not only comply with regulations but also foster a culture of continuous improvement and patient safety.
Who you are:Degree in Pharmacy, Chemistry, or related field (QFB, QFI).
4–9+ years’ experience in pharmaceutical quality or regulatory roles.
Proven experience with GMP, GDP, COFEPRIS, and client/supplier audits.
Strong organizational, communication, and problem-solving skills.
Self-driven and detail-oriented.
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!