Quality Systems Specialist

Who we are

Aizon is a software-as-a-service provider that transforms manufacturing operations in life science industries using advanced analytics and artificial intelligence.

Following our recent Series C round of growth funding, we are looking for ambitious new team members motivated to directly impact our future growth and success as we launch what we consider “Aizon 3.0”.

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.

- We’re 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.

- We’re backed by both industry and software investor firms like NewVale Capital, Atlantic Bridge, Danaher, Honeywell, CrossLink, and UnCork, with solid industry and technology expertise.

Our mission is to improve global health by optimizing how medicines are manufactured so that pharma and biotech companies can provide patients worldwide with the right medicine at the right time and price.

Join us if you are motivated to directly impact our company's success and growth path forward and, more importantly, by positively contributing to the life science industry and deserving patients worldwide.

The Position

Report to: Quality & Compliance Manager

This role is responsible for ensuring that Quality policies and internal procedures are maintained and aligned with business needs, guaranteeing a robust Integrated Management System (IMS) that complies with ISO and SOC standards. Driving consistent system quality by enforcing GAMP (Good Automated Manufacturing Practice) standards throughout the development lifecycle. It involves analyzing data to drive process improvements, enhance product quality, and motivate employees. The position also establishes and maintains quality regulations for both products and personnel, while carrying out the responsibilities of the Data Protection Officer (DPO) to ensure compliance with data protection requirements.

Key Responsibilities:
• Supervise the organization’s Integrated Management System (IMS) to ensure conformity to the customer, internal, ISO guidelines, regulatory/legal requirements, and consistently aligned with business needs.
• Provide advice and support to all departments on Quality Assurance, in particular to Business Technologies teams regarding ISO 9001, 2700,1 and GDPR compliance topics.
• Supervise and approve the Quality verifications of the product prior to release to customers
• Supervise the implementation of change control activities in accordance with company procedures and compliance requirements.
• Supervise the creation and updating of Policies, Standard Operating Procedures (SOP’s), Work Instructions (WI's), and other controlled documents in collaboration with process owners and subject matter experts.
• Work with different teams in order to define key performance indicators (KPI), to optimize processes, supervise them, and ensure continuous improvement of products and processes
• Develop, define the terminology used in documents to ensure easily understood by all audiences.
• Manage the planning and execution of internal audits, preparation of plans, and audit reports.
• Lead internal audits and third-party audits (internal and external), and the implementation of corrective actions.
• Training and awareness of employees and third parties in the area of Quality.

Qualifications - Must-have:
• A profile with Life Science, Engineering, or related studies.
• At least 2 years with a similar experience in implementation and/or auditing of Quality & Security Management systems (ISO 9001 - 27001 - Pharmaceutical Quality Systems).
• Knowledge of cybersecurity topics related to SOC 2 and NIS II.
• Knowledge in Data Protection and GDPR.
• Pharmaceutical regulations: manufacturing (GMP) and computerized systems (21 CFR Part 11 - EuGMP Annex 11).
• 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:
• Basic knowledge of Industry 4.0 concepts and principles.
• GAMP 5 guidelines on Computer System Validation (CSV).
• IT cloud tools: Amazon Web Services, Atlassian ecosystem: Confluence, Jira, Bitbucket, Google G Suite.
• Risk management.
• Agile software development.

The Human We’re Looking For:
• Proficient in spoken and written English.
• Technical writing: procedures, policies, work instructions.
• Ability to read and interpret regulations, guidance documents, technical manuals, forms, and instruction guides.
• Critical eye to be quality-oriented.
• Possessing an agile mindset, being fast to adapt to constant changes, and feeling comfortable with it.
• Naturally questioning everything.
• Excellent communication skills, both within and outside the team.
• Have experience working on a dynamic product that is ever-changing and evolving rapidly.
• Commitment to quality.
• Strong analytical and creative problem-solving skills.
• Ability to take smart risks and champion new ideas.
• Team player, collaborative, innovative, and a get-things-done mindset.
• Ability to understand business requirements and translate them into technical requirements.
• Show initiative in setting and meeting goals within an environment of managed change.

What We Offer

💼 Unique opportunity to join our company as it scales with excellent market traction and huge potential to grow globally
💰 Competitive salary (according to your experience/skills)
📈 Equity, bonuses, and generous stock options
⏰ Flexible schedule - Intensive Fridays
🗣️ Language one-to-one training courses
🏥 Competitive healthcare plans and benefits - Medical & Dental Insurance
🎓 Internal training and certifications plan
🚗 Flexible Remuneration Options
🗂️ Career plan and scheduled salary reviews
🎉 Monthly team-building activities
💻 Top-notch "tech pack" – We are Mac lovers!
🚀 An open and collaborative work environment with a young and dynamic team and a very international culture
💡 An opportunity for personal and professional growth, supported by stellar investors and the exciting challenges that come with joining a company at the start of its growth trajectory

Join our team and significantly impact our company's growth and success as we shake the pharmaceutical manufacturing industry. Apply now and be part of our journey to transform the way pharmaceutical companies operate.

We are dedicated to maintaining an inclusive workplace in which all employees are treated with respect and are able to contribute meaningfully to society. Our organization brings together professionals from diverse backgrounds, representing more than 28 nationalities, and we take pride in being an equal-opportunity employer.
Employment decisions are based exclusively on qualifications, merit, and business requirements. Applicants who require assistance or accommodation due to a disability may contact us at [email protected].