FAMAR AVE., a leading international service provider in health care industry with activities both in the Greek and the Western European area, seeks to recruit :
SUPPLIER COMPLIANCE MANAGER
The position holder will be required to deliver the following strategic objectives :
Development, deployment and oversight of an effective the Supplier Compliance and Qualification Strategy
Supporting cross functional stakeholders and sites on matters pertaining to Suppliers surveillance, Quality System Performance, and related regulatory compliance.
DUTIES AND RESPONSIBILITIES :
The Supplier Compliance Manager is responsible for :
The overall direction, coordination of Supplier Compliance program at Global FAMAR level,ensuring consistency with Company Strategy, Global Quality requirements, commitments and goals.
In particular shall :
Define, deploy and monitor the Supplier Qualification and Compliance Strategy, including the quality metrics for the Supplier Performance in order to drive continuous improvements.
Issue and review in regular basis the Global Annual Supplier Audit Plan based on a risk assessment and coordinate the Global Suppliers Audits execution.
Responsible for the review / approval of Global Suppliers audit reports and CAPAs and monitor of closure of Global Suppliers Audit observations.
Provide guidance and / or assist in defining, implementing and follow-up for local supplier audit reports and CAPA ensuring adequate corrective action is in place.
Monitor and report Global Suppliers quality performance and manage the Supplier Quality Key Performance Indicators.
Define and monitor the FAMAR Quality Supplier auditors’ qualification.
Define Supplier Quality Agreements (SQA) Strategy and lead the implementation of SQAs for all suppliers to ensure quality requirements are met.
Monitor applicable regulations and HAs alerts / warning letters.
Support sites & other functions to new product launches to ensure existing suppliers or new suppliers are suitable for the required quality standards.
Lead the root cause analysis and corrective actions process of supplier critical quality issues.
Identify process improvement opportunities and implement best practices and provide appropriate support and training to the sites to ensure consistency and harmonization across sites.
Support Due Diligence activities providing subject matter expertise to enable decision making by identifying quality related risks to projects and the provision of appropriate resolutions.
Contribute in Global Quality procedures, Quality System and Training as requested.
Contribute and support in Inspections (Internal, Health Authorities, and Customers) as requested.
PROFILE / SKILLS : Languages :
Fluent in English (advanced oral and written skills).
Italian, Spanish, is an advantage.
University Degree in Chemistry / Chemical Engineering / Pharmacy / Biology. Postgraduate studies will be considered an asset.
Advanced PC skills : (excellent MS skills- especially word, excel, PowerPoint), Good knowledge of Intranet applications like SharePoint as a plus.
Minimum 7 years of pharmaceutical industry experience, including 3-5 years in Supplier qualification and participating in GMP third party audits as lead role.
Current knowledge of EU Regulations & Directives, Quality Management Systems and processes (ISO 9001, ISO 13485, ISO 22716) as well as comprehensive knowledge of international GMP regulations and subsequent applications to medicinal products, medical devices, cosmetic, and dietary supplement development is preferred.
Soft skills on change management, time management, listening, autonomy, self-confidence, problem solving, results oriented, able to work under remote management.
Demonstrated teamwork, collaborative and consensual A colleague that people turn to for advice and want to work with.
Good communication skills (oral and written) with a clear and concise presentation style and the ability to convey the vision in a manner readily accessible and understandable to all.
Strong financial / business awareness and good negotiation skills
Must be able to partner with a diverse group with different strengths and skills and have the ability to prioritize work and manage multiple projects, while maintaining quality.
Ability to work independently and as part of a team in a very busy and fast-moving working environment.
Ability to travel up to 50% in both domestic and international travel.