Bologna, IT IT Milano, IT
Specialist, Quality Assurance GCP
Purpose of the Job
The Clinical Quality Assurance Specialist supports the implementation and maintenance of an effective Clinical Quality Management System (QMS) to ensure ICH-GCP compliance for all sponsor-led clinical development activities.
The role provides operational QA support and oversight for clinical trials mainly in Phase II to Phase IV, contributing to inspection readiness, vendor oversight, and continuous improvement of clinical quality processes.
Key Responsibilities:
- Support the implementation and maintenance of the Clinical Quality Management System, including SOPs, work instructions, and templates
- Perform clinical quality oversight activities in support of Sponsor responsibilities, including: Study level and system level audits and Vendor and CRO audits and qualifications
- Participate in risk-based quality activities, including quality risk assessments and audit planning
- Support oversight of outsourced clinical activities, ensuring CROs and vendors operate in compliance with ICH GCP and contractual obligations
- Manage and track deviations, CAPAs, and quality issues, supporting root cause analysis and effectiveness checks
- Contribute to inspection readiness activities, including preparation of documentation, mock inspections, and follow up actions
- Support regulatory inspections and audits by health authorities (EMA, FDA, MHRA) as part of the Sponsor QA team
- Provide GCP guidance and quality input to Clinical Operations, Clinical Development, and cross functional teams
- Support the delivery of GCP training and quality awareness initiatives across the organization
- Contribute to continuous improvement initiatives to enhance efficiency, compliance, and quality culture.
Qualifications:
- Minimum 4–6 years of experience in Clinical Quality Assurance, Clinical Operations, or related GxP functions.
- Hands on experience supporting Phase II–IV clinical trials.
- Experience working with CROs and external vendors.
- Exposure to regulatory inspections or Sponsor audits is preferred.
- Good knowledge of ICH GCP guidelines and applicable global clinical trial regulations.
- Understanding of sponsor responsibilities in outsourced clinical trial models.
- Familiarity with quality systems, audit processes, and CAPA management.
- Ability to apply a risk-based approach to quality oversight.
- University degree in Life Sciences, Pharmacy, Biology, Chemistry, Medicine, or related discipline.
- Solid understanding of GCP principles and clinical trial processes.
- Strong organizational and time management skills.
- Ability to work effectively in a matrix and cross functional environment.
- Clear and effective written and verbal communication skills in English.
- Problem solving mindset with focus on quality and compliance.Proactive, collaborative, and detail-oriented approach.
- Knowledge of digital tools
Company:
Alfasigma is a global pharmaceutical company founded over 75 years ago in Italy, where it is headquartered (in Bologna and Milan). The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. It has offices in many countries, including Italy, the US, Spain, Germany, Mexico, and China; production sites in Italy (Pomezia, RM; Alanno, PE; Sermoneta, LT; Trezzano Rosa, MI), Spain (Tortosa, Baix Ebre), and the United States (Shreveport, Louisiana); and R&D labs in Italy (Pomezia and Bergamo). Alfasigma employs approximately 4,000 people dedicated to research, development, production, and distribution of medicinal products, contributing to its mission to provide better health and a better quality of life for patients, caregivers, and healthcare providers. It focuses on three main therapeutic areas: Gastroenterology, Vascular, and Rheumatology. Its portfolio spans from primary care to specialty care, rare disease medications, and consumer health products, including medical foods and nutraceuticals.