quality gdp compliance manager m/f - Levallois-Perret, France - GEODIS

Description

Position description

Type of assignment

Full-time Regular

Function

Support function - Business Excellence

Job title

QUALITY GDP COMPLIANCE MANAGER M/F

Job description

The Job consists in the following key activities:

•The Business Excellence – Global Quality GDP Compliance Manager shall:

•Support Freight Forwarding organization to maintain a robust and compliant worldwide GDP Quality 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, etc.)

•Develop and launch a Pharma & Healthcare 'Audit Program' and perform audits on core or strategic suppliers, in addition to hosting global and strategic customer audits and quality reviews. Monitor action plans based on audit findings and report status to interested parties as applicable.

•Monitor GDP Regional and Country customers and suppliers' audits advising as appropriate on performance requirements (LoB, Region, Countries).

•Perform Regional /Country GDP inspections and/or gap assessments and report performance as appropriate to Top Management (LoB, Region, Countries).

•Provide training where required to ensure all GEODIS staff involved in the handling/distribution/transportation of medicinal products are competent to do so; maintain training records available to all interested parties.

•Onboard Regional GDP Responsible Persons (new hires).

•Assess Regional GDP regulatory compliance level.

•Advise on licensing and registration process, support regions and countries with the application of activities and provisions per applicable wholesale distribution authorization (WDA) with adequate processes/procedures.

•Manage the roll out and implementation of global GDP certification programs i.e. IATA CEIV Pharma, Certipharm, SGS, etc, as applicable.

•Support and customize Quality and GDP 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 global level.

•Report on the status of network GDP risks and compliance to the required stakeholders.

•Ensure relevant customer complaints are handled effectively, performing trend analysis, and reporting accordingly to required levels of the organization.

•Approve lane risk assessments as required.

•Implement processes to ensure due diligence checks and suppliers and customers are qualified.

•Implement processes to ensure that the organization consistently adhere to any additional requirements imposed on certain products by national law e.g. specials, unlicensed imports and controlled drugs

Applicant's profile

REQUIREMENTS:

•Bachelor or master's degree in Quality Management, Logistics, Pharmaceutical Sciences or equivalent.

•Relevant experience related to the distribution of medicinal products 'WHO' and 'EU GDP'

•ISO 9001 Standard.

•Project Management.

•Fluent in English language: written and spoken
The individual should understand:

•The principles and guidelines of Good Manufacturing Practice-GMP and how Good Distribution Practices-GDP principles maintain product quality throughout the supply 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 of requirements to obtain a 'Wholesale Distribution Authorization (WDA).

•Knowledge of IATA CEIV Pharma certification process and/or TCR – Temperature Control Regulations standard (desirable).

•Minimum 3-5 years' experience within a Pharmacy operational environment with key knowledge of a diverse pool of countries regulatory agencies requirements.

•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 organizations 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, France, Île-de-France, Hauts-de-Seine

Location

Candidate criteria

Minimum level of education required

BACHELOR'S DEGREE

Years of experience in similar position

Confirmed (5 to 10 years of experience)

Languages

English (Intermediate)