Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa.
Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health. We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities.
But our journey is far from complete! In fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets.
Job Purpose
The Sr. Specialist, Computer System Validation (CSV), Quality is responsible for managing and supporting Computer System Validation activities for GxP global computerized systems, ensuring compliance with applicable regulatory requirements, industry standards and Alfasigma Quality Policies and Procedures.
The role contributes to the company’s digital transformation initiatives by supporting the implementation, validation and maintenance of electronic systems used across Quality and GxP-regulated environments. The position works in close collaboration with Global Quality, Local Quality Teams, IT and external partners to ensure validated, compliant and efficient computerized systems.
Key Responsibilities
- Manage Computer System Validation (CSV) activities for GxP global computerized systems in compliance with regulatory requirements, industry standards and internal procedures.
- Support projects from a CSV perspective, including:
- definition of validation strategies;
- review and approval of validation documentation;
- coordination of external consultants and vendors;
- oversight of validation activities throughout the system lifecycle.
- Support the maintenance and continuous improvement of Global Quality Policies and Procedures related to CSV and ensure their consistent application across manufacturing sites and company affiliates.
- Collaborate with Global Quality and Local Quality Teams during Regulatory Agency and Customer audits, providing CSV-related support and documentation.
- Contribute to the company digital transformation program through the implementation of new electronic systems and upgrades of existing platforms.
- Work closely with the IT Department to support business needs related to electronic systems, applications and digital tools.
- Support data migration activities ensuring compliance, traceability and data integrity principles.
- Ensure that computerized systems are maintained in a validated state throughout their lifecycle.
- Participate in risk assessments, change controls, deviations and CAPA activities related to computerized systems.
- Promote compliance with Data Integrity principles and applicable GxP requirements.
Qualifications & Experience
Work Experience
- Significant experience (5–7 years) in Computer System Validation within a pharmaceutical or other highly regulated environment.
- Significant experience managing or supporting data migration activities.
- Experience in Clinical Studies, Regulatory Affairs and/or Pharmacovigilance systems will be considered a plus.
- Proven experience managing validation activities for GxP computerized systems.
Education
- Degree in a scientific, Information Technology or Engineering discipline.
Competencies & Major Skills
- Deep knowledge of cGMP requirements and pharmaceutical quality systems.
- Strong knowledge of CSV regulations and guidelines from major Regulatory Agencies (FDA, MHRA, EMA/EU GMP, etc.).
- Good understanding of Data Integrity principles and risk-based validation approaches.
- Strong project management and organizational skills.
- Ability to work effectively within cross-functional and multi-disciplinary teams.
- Ability to independently manage projects and priorities.
- Analytical mindset with strong problem-solving capabilities.
- Excellent communication and stakeholder management skills.
- Good command of the English language, both written and spoken.
Why Join Alfasigma:
At Alfasigma, we foster a culture where the courage to innovate is key to our success.
We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.
Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress.
Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.
