Quality Program Associate
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Job Summary
We are a fast-growing company entering an exciting new stage of expansion and we are looking for ambitious new team members who are motivated to directly impact our growth and success. If you want your work to make a visible difference as we scale this is the place to do it.
Aizon is helping pharma manufacturers and CDMOs make better decisions in GMP operations.
- What makes us different from other manufacturing platforms We help operations leaders and engineers avoid endless cycles of chasing data in disparate and heavy-handed systems and rapidly understand how to run their manufacturing processes better.
- Were solving multiple problems in GMP operations that cost manufacturers millions yearly while accelerating their digital maturity journey. One of our unique capabilities is the ability to operationalize the use of predictive AI models in real time without a big data science staff.
- Were backed by leading industry and software investor firms with solid industry and technology expertise giving us the foundation to grow with confidence.
Join us if you are motivated to directly impact our companys success and growth path forward and more importantly to positively contribute to the life science industry and deserving patients worldwide.
The Position:
Report to: Quality and Compliance Manager
This is an early-career opportunity to join Aizons Quality & Validation function and support the delivery of our GxP software solutions into highly regulated pharmaceutical manufacturing environments. Working closely with senior quality validation and delivery colleagues you will help build and maintain the quality program that underpins our customer implementation projects from quality planning and computer system validation (CSV/CSA) to documentation and inspection readiness. The scope of this role is to ensure that projects derived from the implementation of Aizons products are properly implemented in GxP environments.
The role is a key contributor to Aizons success: by ensuring our projects meet GMP and regulatory expectations you help our customers go live faster and with confidence protecting data integrity and ultimately supporting the safe and timely delivery of medicines to patients. Its also a great launchpad to grow into more senior CSV QA or project delivery roles.
Key Responsibilities:
Support the creation maintenance and execution of quality plans for customer implementation projects ensuring alignment with GMP/GxP requirements.
Assist in computer system validation (CSV/CSA) activities for Aizon solutions helping draft and execute validation deliverables (validation plans requirements and specifications IQ/OQ/PQ test protocols traceability matrices and validation summary reports).
Help coordinate GMP implementation projects: tracking deliverables timelines and action items across internal and customer teams.
Provide support on validation and compliance consulting engagements helping gather customer requirements and translate them into quality and validation documentation.
Maintain documentation and records in line with data integrity (ALCOA) and good documentation practices (GDP).
Assist with change control deviation and CAPA documentation related to project delivery.
Perform internal audits to ensure that the projects documentation related to the GxP implementation is properly developed and the project is executed according to the GAMP 5 guidelines.
Help prepare and organize validation and quality evidence to support customer audits and inspection readiness.
Support and lead external audits performed by customers on the project documentation related to Aizon Execute and/or Aizon Platform implementation.
Collaborate with product engineering and delivery teams to ensure quality is built into every solution delivery.
Contribute to the continuous improvement of internal quality program templates SOPs and best practices.
Qualifications: Must - Have
Bachelors degree in a relevant field (Pharmacy Biotechnology Chemistry Engineering Life Sciences Computer Science or similar).
02 years of experience (including internships) in quality validation regulatory affairs or project support ideally within pharma/biotech a GMP setting or a regulated software environment.
Familiarity with GMP/GxP concepts and quality systems or a strong willingness and ability to learn them quickly.
Solid written and verbal English (our working language) with the ability to produce clear well-structured documentation.
Strong attention to detail organization and documentation discipline.
Comfortable working with software tools and digital systems.
Willing to comply with and follow all regulations required when working in a highly regulated environment such as ISO standards and GMP regulations.
Qualifications: Nice to Have
Exposure to Computer System Validation (CSV) / CSA and GAMP 5.
Knowledge of data integrity principles (ALCOA) and 21 CFR Part 11 / EU Annex 11.
Experience with project management tools and methodologies.
Understanding of pharmaceutical manufacturing operations (batch records deviations PQR etc.).
Spanish and/or additional languages.
Familiarity with SaaS/cloud solutions or AI/analytics in regulated environments.
Knowledge and experience with the Atlasian ecosystem
The Human Were Looking For:
Curious and eager to learn and excited to grow in an international complex regulated and fast-moving domain.
Detail-oriented and organized you take accuracy and documentation seriously.
Proactive and reliable you follow through take ownership and flag risks early.
A clear communicator and team player comfortable working across technical and non-technical stakeholders internally and with customers.
Adaptable you thrive in a scale-up pace and stay calm with a degree of ambiguity.
Quality-minded you understand that doing things right is not bureaucracy; its how great medicines reach the people who need them.
Required Experience:
IC
