Founded 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 team at Fidia, we are looking for a Quality Assurance and Compliance Manager (m/f/d).

Main responsibilities

GPV

Supporting and advising in the interpretation of applicable local and EU Pharmaceutical Legislation for the incorporation, as requirements, into the company procedures and policies
Development and maintenance of the local Quality Management System and coordinating the preparation and/or the revision of Local SOPs and Working Instructions, in compliance with corporate policies, corporate quality requirements and corporate standard operating procedures
Ensuring the preparation of the Quality Management Review and monitoring implementation of any need for improvement
Participating in cross-functional teams providing GVP advice and guidance on risk identification and risk-based approach in Quality Management
Ensuring implementation of a vendor management process, in compliance with the vendor management corporate SOPs
Setting-up and managing the Deviation monitoring system to ensure timely remediation of non-compliance, including the performance of any needed Root Cause Analysis, evaluation of suggested CAPAs and assessment of their effectiveness
Coordination at local level of any regulatory inspections, including inspection readiness and preparation, hosting/management of inspections and any required follow-up activities
Coordinating internal GxP training programs and maintaining training documentation
Leading the quality team and ensuring that qualifications are maintained

GDP

Act as Responsible Person according to GDP Chapter 2.2
Implement and update all documents constituting the QMS according to GDP requirements and in compliance with the specific local regulation
Guarantees the validation of sw system impacting GDP requirement
Issue the documents in line with the Corporate Policies requirements
Inform Fidia Headquarter of the results of any inspection received by Authority to share the non-conformities and related CAPA plan
Guarantee the registration and management of complaints from the market both for medicinal products and Medical devices and other category types (e.g. cosmetics, food supplements) distributed in the Territory (Germany and Austria)
Implement a subcontractors' monitoring system, including periodic audits to the warehouse used for the storage and distribution of Fidia's products
Guarantee the issuing of Quality Agreement with subcontractors
Maintain the activities defined in the Quality Agreement and other documents (e.g. Distribution Agreements, Memorandum of Understanding) with Fidia Headquarter
Support Fidia Headquarter in case of recall and guarantee the contact with the Regulatory Authority

Requirements

3-5 years of experience in Quality Assurance, Compliance, Regulatory Affairs, Pharmacovigilance Quality Systems, or related functions within the pharmaceutical and/or medical device industry
Proficiency in Quality Management Systems, audits and inspections, regulatory compliance, deviations/CAPAs, Pharmacovigilance Quality activities, and stakeholder engagement, including Health Authorities
Deep knowledge of EU pharmaceutical legislation governing the distribution of medicinal products and medical devices, including Good Distribution Practice (GDP) requirements
Strong understanding of local and European Pharmacovigilance Quality Systems, including Directive 2001/83/EC, Commission Implementing Regulation (EU) No. 520/2012, AMG, and Good Pharmacovigilance Practices (GVP)
Strong analytical, organizational, and problem-solving skills
Ability to work independently and manage multiple priorities in a regulated environment
Excellent communication and stakeholder management skills
Proficiency in Microsoft Office applications and quality management software
German and English language proficiency at a minimum level of C1/C2 (written and spoken)

Our offer

Permanent employment contract
Company pension scheme after one year of service
Professional development opportunities, including language courses, technical training, and personal growth programs
Salary between € 85.000 and € 95.000 per year
An international and collaborative work environment with opportunities for career growth

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.

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