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").