At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
As a
Quality Assurance Specialist (GMP) at Roche
, you will play a critical role in safeguarding product quality, regulatory compliance, and patient safety across local affiliate operations. You will contribute to the strength and effectiveness of the Pharmaceutical Quality System, ensuring that both commercial and clinical trial products are released and managed under the highest GMP and regulatory standards. Acting as a trusted quality partner across the supply chain, you will support continuous improvement initiatives and reinforce Roche's commitment to delivering safe, high-quality medicines to patients.
The Opportunity
Ensure
GMP compliance
across warehouse and distribution operations, in line with Roche standards and regulatory requirements.
Review, compile and manage
product release documentation
, including materials submitted to Health Authorities.
Administer and maintain the
local SOP management system (Veeva Docs)
, ensuring procedures are current, controlled and accessible.
Manage
quality events
(deviations, non-conformities, CAPAs and change controls), ensuring timely investigation, closure and cross-functional accountability.
Participate actively in
self-inspections, audits,



supplier qualifications and regulatory inspections
, including first-batch and GMP inspections.
Provide
technical quality support
for complaints, inquiries, recalls and risk assessments, documenting activities in Veeva Vault OneQMS.
Support the
local implementation of general PQS documentation
and contribute to cross-affiliate quality collaboration when required.
Who You Are
You hold a
Bachelor's degree in Pharmacy
(or equivalent scientific discipline) and have experience in GMP-regulated environments.
You bring a
strong quality mindset
, with attention to detail, integrity and a clear focus on patient safety.
You are organized, autonomous and able to
manage multiple priorities
effectively in a regulated, fast-paced setting.
You demonstrate
strong communication and stakeholder management skills
, working confidently across cross-functional teams.
You are proactive and improvement-oriented, with the ability to act with
urgency while maintaining full compliance
.
This position does not offer relocation benefits.
Who we are
A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.
Roche is an Equal Opportunity Employer.

📌 Quality Assurance Specialist (Buenos Aires)
🏢 Roche
📍 Buenos Aires