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Job Description:

Job Summary

Location: Airborne Avenue 55-57, Hoofddorp, the Netherlands.

·HC QA Specialist (Transportation) has day to day oversite of the transportation quality systems supporting UPS Healthcare and the Ground Transportation Carrier Certification Program.

Key Responsibilities

General

• Implements policies, procedures and specific work instructions with internal and external stakeholders

• Manages communications with internal and external stakeholders

• Interacts with industry and regulatory agencies and interprets standards / regulations impacting transportation and the quality systems

• Supports internal and external audits as well as facilitating and responding to client / agency audits / supplier/carrier

• Remains current with applicable regulations

• Liaisons with internal and external subject matter experts in changing regulation or interpretation

• Liaisons with clients and other industry experts regarding industry standards and expectations.

• Provides guidance and support to Business Development (BD) and Customer Solutions regarding healthcare compliance with and interpretation of regulations, including support for RFA/RFI requirements

• Supports operationally obtained certifications (e.g. CEIV, ISO etc.) as they impact the quality systems and or UPS Healthcare Compliance matters

• Conducts assessments of current UPS transportation capabilities to determine the ability to meet client requirements and proposed solutions

• Conducts risk assessment procedures and processes to minimize risk

• Conducts consultations with Management to determine compliance implications of pending business opportunities

• Ensures document control systems are current and comprehensive

• Evaluates and manages procedures across locations to ensure consistency in content and implementation.

• Assesses supplier/carrier questionnaire data for capability

• Conducts supplier/carrier audits and produces audit reports

• Develops audit improvement plans (AIP) for supplier/carriers

• Supports UPS supplier/carrier relationship holder, as required, to close any AIPs

• Supports all track and trending of external audit finding results

• Performs annual competency evaluations of supplier/carriers

• Supports the supplier/carrier approval / qualification / certification program

• Supports the supplier/carrier quality and technical agreement process

• Produces reports as required

• Supports carrier relations and supplier/carrier relationship holders with nonconformance and incident reporting systems related to transportation activities and the affected supplier/carrier, reviews and may approve any investigation / root cause analysis findings

• Supports the tracking and trending of nonconformance and incidents

• Ensures required quality system revisions resulting are implemented

• Internal and External Stakeholder Collaboration

Key Interactions

Internal

• Healthcare Compliance

• Leadership / Operations (Global Freight Forwarding, Small Package, Express Critical, WWEF, NAAF, Temperature True Packaging)

• Solutions / Implementations

• Legal

• Program Management / BD/ Account Management

• Strategy/Marketing/Product

• OE/IE/PE

• Carrier Relations

• Security

• Brokerage

External

• Client (QA, Ops, Procurement)

• Regulatory / Industry Agencies (e.g. FDA, IATA, Customs, etc.)

• Supplier/carriers / Subcontractors

• Third party auditors

Knowledge and Experience

• Bachelor of Science or Arts degree or international equivalent preferred

• Experience in healthcare compliance / regulatory affairs

• Experience with GMP and/or GDP guidelines

• Knowledge of ISO 13485 and 9001 standards

• Experience with Transportation / Supply Chain industry

• Proficiency in English required (written and verbal)

• Proficiency in second language preferred

• Strong technical quality and regulatory affairs (QA/RA) knowledge

Employee Type:

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