Deviations and complaints supervisor

We are looking for a Deviations and Complaints Supervisor who supervises and guides the management of quality deviations and complaints, identifies the main causes, and develops effective CAPAs, collaborates with business functions, ensures regulatory compliance, and contributes to the continuous improvement of the quality system.

Key Responsibilities

Supervise the management of process, system, and product deviations
Coordinate the initiation, analysis, risk assessment, and closure of deviations
Supervise the management of quality complaints, including assessment of impact on product safety and efficacy
Ensure compliance with timelines and regulatory requirements (GMP, GDP, EMA/FDA regulations)
Approve root cause investigations (e.g., RCA, 5 Why, Fishbone)
Ensure the definition, implementation, and verification of the effectiveness of CAPAs
Interface with Production, Quality Control, Regulatory Affairs, and Supply Chain
Support internal and external inspections and audits, including regulatory authorities
Draft and review procedures, reports, and trend analyses on deviations and complaints
Monitor trends, KPIs, and quality performance indicators

Required Qualifications
Degree in scientific disciplines (Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry, Biology, or related fields)
Technical Skills

Minimum of 7 years of experience in Quality Assurance within the pharmaceutical or biotech industry
Excellent command of English, both written and spoken Soft Skills

Leadership and supervisory skills
Attention to detail and compliance-oriented mindset
Ability to work in regulated environments
Effective communication and cross-functional collaboration This job posting is open to candidates of any gender, gender identity, and gender expression, in accordance with Italian Laws 903/77 and 125/91, and to candidates of all ages and backgrounds, in accordance with Legislative Decrees 215/03 and 216/03.
By applying for this position, candidates authorize the processing of their personal data pursuant to Article 13 of Legislative Decree No. 196 of June 30, 2003 ("Personal Data Protection Code") and Article 13 of GDPR 679/16 ("EU General Data Protection Regulation").