Corporate R&D Quality&Compliance Expert

Fidia Pharma GmbH; Giarre; In loco; EUR 29.900 - 37.360; Tempo pieno

Vantaggi offerti da questo lavoro

Collective bonus

Company canteen

Pension fund

Descrizione del lavoro

Fidia Pharma GmbH, headquartered in Abano Terme (PD) Italy, seeks a Corporate R&D Quality & Compliance Expert to strengthen the Corporate R&D Quality Management System and ensure GxP compliance across the organization.

The role involves interpreting GCP/GVP regulations, providing cross‑functional GxP guidance, and coordinating audits and CAPA activities. A scientific degree with at least 1 year in QMS is required, with English proficiency at C1 level.

Competenze

• Bachelor's degree in Pharmacy, Chemistry, Biology, Biotechnology or related field.
• Master’s degree preferred.
• At least 1 year of experience in Quality management system (QMS) in R&D/QA GxP within pharma, CRO or service provider.
• Fluent written and spoken English (C1).

Mansioni

• Support development, maintenance, and revision of Corporate R&D QMS, including SOPs and work instructions.
• Interpret GCP/GVP regulations and translate them into company procedures and policies.
• Provide GxP advice in cross-functional teams, supporting risk-based Quality Management.
• Plan, conduct, and report vendor audits; maintain Qualified Vendor Registries and coordinate regulatory inspections.
• Oversee CAPA implementation, manage deviation monitoring, root cause analysis and remediation of noncompliance.
• Assist in staff qualification, training activities and training documentation; support Computer System Validation projects.

Conoscenze

Quality management

GxP knowledge

MS Office

English proficiency

Formazione

Bachelor's degree in a scientific field

Master's degree

Strumenti

Microsoft Office

Descrizione del lavoro

## Corporate R&D Quality&Compliance ExpertApplyremote type: Site basedlocations: Abano Termetime type: Full timeposted on: Posted 2 Days Agojob requisition id: R-00074Founded in 1946, Fidia is an Italian multinational pharmaceutical company, with R&D, manufacturing, marketing and sales capabilities, and an extensive product portfolio, mainly based on Hyaluronic Acid, in strategic therapeutic areas such as Joint Care, Eye Care, Skin Care, Specialty Care, Health&Wellness Care. Headquartered in Abano Terme (PD), Fidia extends its global reach through local partners and distributors in 120+ countries worldwide, as well as with wholly owned subsidiaries. **Job Description**To strengthen our Corporate Clinical Safety, Pharmacovigilance and R&D Compliance team, we are recruiting a**Corporate R&D Quality & Compliance Expert****Main responsibilities:*** Support the development, maintenance, and revision of the Corporate R&D Quality Management System, including Corporate/Local SOPs and Working Instructions.* Assist in the interpretation of GCP/GVP-related regulations (ICH, EU, FDA, etc.), translating them into company procedures and policies, and preparing the Quality Management Review.* Provide GxP advice in cross-functional teams, supporting risk identification and risk-based Quality Management approaches.* Support planning, conduction, and reporting of vendor audits, maintain Corporate Qualified Vendor Registries, and coordinate third-party audits and regulatory inspections, including inspection readiness and follow-ups.* Oversee the implementation of CAPA Plans from inspections and audits, manage the Deviation monitoring system, support the performance of Root Cause Analysis, assess CAPAs, and ensure timely remediation of noncompliance.* Assist in staff qualification, training activities, and maintaining relevant training documentation an support Computer System Validation projects within the Corporate R&D Quality Management System.**Requirements:*** Bachelor's degree in the scientific field (e.g., Pharmacy, CTF, Biology, Biotechnology) and, preferably, Master’s degree.* At least 1 year of experience in Quality management system in R&D/QA GxP, within a pharma industry, CRO or a service provider.* Good knowledge of Clinical and Pharmacovigilance norms/guidelines/regulations.* Fluent knowledge of English language written and spoken (C1 level).* Good proficiency in using the Microsoft Office suite.* Strong accuracy, discipline and cooperation skills.**Our offer:*** Open ended contract.* Salary between € 29.900 and € 37.360.* Collective Bonus and company Welfare. **Fidia benefits:** In Fidia you will have unlimited access to training and coaching programs aligned with market best practices and opportunities for professional development through participation in internal job posting processes, pension fund with company integration and health fund, merit review and referral programs, company canteen, staff discounts and access to the flu vaccination campaign. *Fidia Farmaceutici promotes parity and inclusion in all its actions. All people from the status of candidate to that of employee and throughout the duration of their employment relationship are entitled to the same opportunities and protections regardless of gender identity, sexual orientation, ethnicity, migration background, religion, nationality, age. All company procedures are therefore drafted in compliance with the principles expressed in the previous point; any divergences should be promptly brought to the attention of the People & Culture Department.*