Quality Assurance and Compliance Manager (m​/f​/d

Position: Quality Assurance and Compliance Manager (m/f/d)
Location: Germany

## Quality Assurance and Compliance Manager (m/f/d)
Apply locations:
Monheim am Rheintime type:
Full time posted on:
Posted Yesterday job requisition :
R-00073

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…