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Business Excellence Manager - Global GDP compliance


Vacancy details

General information

Legal entity

GEODIS is a Supply Chain Operator ranking among the top companies in its field in Europe and the World. GEODIS, which is part of SNCF Logistics, which in turn is a business line of the SNCF Group, is the number one Transport and Logistics operator in France and ranked number four in Europe. The international reach includes a direct presence in 67 countries and a global network spanning over 120 countries.

Why join us ?

Transport and Logistics form a key sector in the world economy. As a major international player on this sector, GEODIS is geared to full satisfaction of all stakeholders, starting with its workforce, more than 39500 men and women worldwide who share the same values of commitment, innovation, trust, solidarity and passion that form the pillars of GEODIS corporate strategy.  

Reference

2020-6276  

Position description

Type of assignment

Full-time Regular

Function

Support function - Business Excellence

Job title

Business Excellence Manager - Global GDP compliance

Job description

GEODIS is a worldwide company providing transportation services to the Pharmaceutical and Healthcare Industry and has a global, regional and country GDP management following EU/WHO GDP guidelines.
As a Business Excellence Manager – Global GDP Compliance you will be a part of the Cross-Business LoB Freight Forwarding with focus on the Global Pharma & Healthcare strategy. This will be a full time position, part of the Business Excellence (Quality Safety & Health and Environment) Team, reporting to the Freight Forwarding Business Excellence. This role will report to the Business Excellence Director of Freight Forwarding.
• Support the FF organization to implement a robust and compliant GDP Quality Management System
• Coordinate and support implementation of industry-specific guidelines, rules and standards applicable to the Geodis Pharma & Healthcare business scope
• Monitor performance of the GDP Quality Management System and assess its effectiveness
• Promote process improvements and program improvements as necessary
• Coordinate and budget for Global GDP expenditures (i.e. training, certifications, supplies, etc.)
• Develop and launch a Pharma & Healthcare ‘Audit Program' and perform audits on global suppliers, in addition to hosting global and strategic customer audits and quality reviews
• Monitor GDP Regional and Country customers and suppliers audits advising as appropriate on performance requirements (LoB, Region, Countries)
• Perform Regional /Country GDP inspections or risk assessments and report performance as appropriate to Top Management (LoB, Region, Countries)
• Provide training where required to ensure all GEODIS staff involved in the distribution of medicinal product is competent to do so; maintain training records centrally and available to all interested parties
• Onboard Regional GDP Responsible Persons (new hires)
• Assess Regional GDP regulatory compliance level
• Advise country licensing and registration process, and support regions and countries with the application of activities and provisions in accordance with the wholesale distribution authorization (WDA) and adequate applicable company processes and procedures
• Manage the roll out of a global certification program i.e. CEIV, Certipharm, SGS, etc as applicable
• Support and customize content for global or strategic Pharma & Healthcare customer tenders
• Support Pharmaceutical and Healthcare Global or Strategic accounts implementation throughout the network
• Identify and mitigate risks of GDP non-compliance on a regional/country level
• Report on the status of network GDP risks and compliance to the Business Excellence Director
• Ensure relevant customer complaints are handled effectively, performing trend analysis and reporting that accordingly to required levels of the organization
• Approve final lane validations Global/Region
• Implement processes to ensure due diligence checks and suppliers and customers are qualified

Applicant's profile

• Quality Management
• Bachelor or master's degree in Logistics, Pharmaceutical Sciences or equivalent
• Relevant experience related to the distribution of medicinal products and WHO/EU GDP and ISO Standards
• Fluent in English language: written and spoken

The individual should understand:
• The principles and guidelines of Good Manufacturing Practice and how GDP principles maintain product quality throughout the distribution chain
• The role of the Regulatory Agency in the licencing of medicines and the competent authority including the risk-based inspection process, the role of the enforcement group, and resulting actions that can be taken due to non-compliance
• Knowledge to requirements to obtain a ‘Wholesale Distribution Authorization (WDA)'
• Minimum 3-5 years' experience within a Pharmacy operational environment with key knowledge of a diverse pool of countries regulatory agencies
• Minimum 3-5 years' experience managing a program aligned to EU/WHO GDP Guidelines

In addition, the individual also should have knowledge of:

• The role of the professional bodies or public health organisations that regulate supplying medicinal products to the public e.g. FAGG, FDA, MHRA, ANVISA, etc…
• The role of the United Nations in relation to the handling of controlled drugs
• The role of the Veterinary Medicines Directive in relation to veterinary medicines
• The role of the European Medicines Agency and use of EUDRAGMDP
• The role of World Health Organization - WHO
• The falsified Medicines Directive

Working time (%)

100

Position location

Position place

Europe

Location

Europe

Candidate criteria

Minimum level of education required

ENGINEER

Years of experience in similar position

Confirmed (5 to 10 years of experience)

Languages

English (Fluent)