Compliance Specialist - Humanitarian Aid (NFP, intern'l, medicinal products)/ Conformité (médicale)

July 15 2019
Industries Healthcare, social assistance
Categories Pharma, Biotech, Sciences, R&D, Scientific and Regulatory affairs, Quality assurance and control - Validation, Logistics - Distribution - Shipping, Govt., NPO, Social & Community work, Pharma, Biotech, Sciences, R&D, Govt., NPO, Social & Community Work
Montreal, QC

 Compliance Specialist - Humanitarian Aid (NFP, international, medicinal products) /

 Spécialist(e) à la conformité (OSBL, international, santé)

CONTRACT 1 year, extension or permanence possible CONTRAT  

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The World Federation of Hemophilia (WFH - http://www.wfh.org) is an international not-for-profit organization that provides global leadership to improve and sustain care for people with inherited bleeding disorders, including hemophilia, von Willebrand disease, rare factor deficiencies, and inherited platelet disorders. Established in 1963, the WFH works with member organizations in 140 countries as well as through a network of international volunteers and healthcare providers to achieve our vision of "Treatment For All" around the world.

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The WFH is currently seeking a self-starting, highly knowledgeable and results-oriented COMPLIANCE SPECIALIST (1 year contract, with possibility of renewal or permanence) to support the activities of the Humanitarian Aid (HA) department overall –  mainly, the shipping of WFH donations of hemophilia treatment products to recipients countries in the developing world according to the annual donation plan of the HA department.

Reporting to:                   Director, Medical & Humanitarian Aid                                                                        

Type of position:              full-time; contact 1 year (possibility of extension or permanence

Location:                          WFH Headquarters - Montreal (downtown)

Start Date:                       AS SOON AS POSSIBLE  (early SEPT 2019, at latest)

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SUMMARY -

The Compliance Specialist, Humanitarian Aid (HA) – TEMPORARY, 12 mts (extension-permanence possible) is responsible for ensuring that the WFH export and import of donated medicinal products throughout the developing world is accomplished in a compliant and secure manner, and for respecting all necessary documentation and quality standards, including adherence to General Distribution Procedures (GDPs). 

The incumbent ensures all document requirements and controls supporting the WFH HA compliance process are fully adhered to and completed. He/she also assesses on a continuous basis and strengthens the observance of established policies, standard operating procedures and other relevant guidelines in order to ensure compliance with all applicable rules, regulations and WFH contractual obligations.  

The Compliance Specialist partakes as need be in the preparation and presentation of content for the training of personnel in recipient countries who are responsible for the importation, transportation, storage, utilization, and reporting on hemophilia donated products. The incumbent also travels as necessary to recipient countries to make assessments and participate in decisions on capabilities and readiness to receive donations of hemophilia and bleeding disorders treatment products.

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Principal Duties & Responsibilities

  • Develop and update in collaboration with the Medical & Humanitarian Aid Director, strategies and policies to evaluate & control risk associated with WFH donation program's operations, as well as Key Performance Indicators (KPIs) linked with the compliance of the HA program to GDP requirements, others.
  • Upkeep and maintain the QMS (quality management system): ensure documents completion and generate reports linked to KPIs in order to evaluate program performance and compliance relative to established Standard Operating Procedures (SOPs), others.
  • Review and evaluate on an ongoing basis, the effectiveness and efficiency of the HA donation program and its operations, the adequacy of its internal documentation, as well as controls and safeguards, relative to pharmaceutical compliance, applicable laws and WFH contractual obligations.

 

  • Carry out investigations of any compliance incidents and suggest solutions.
  • Plan and perform audits, and report back on results to ensure that procedures are in place, properly implemented and managed according to projects.
  • Follow up on the implementation of audit recommendations and management actions.
  • Advise and monitor quality standards and make recommendations for improvement, corrective actions, and design preventive actions as need be.

 

  • Develop operational validation and quality-based procedures.
  • As need be, perform site visits to recipient countries of HA donations to validate SOPs, test procedures, train personnel. Partake as necessary in regional workshops or in-country training to ensure that quality related requirements are met.

Carry out any other task relevant to the position as required by the Medical & Humanitarian Aid Director, or delegate.

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QUALIFICATIONS & REQUIREMENTS –

  • Bachelor's degree in engineering, science, or other relevant discipline; QA certification – an asset
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  • Minimum of five (5) years of relevant working experience in pharmaceutical sector, including three (3) years of proven track record in QA / QC functional role

 

  •  Knowledge and experience with audit standards and contractual requirements; attentive to details & procedural methodology

 

  • Strong interpersonal and communication skills, with ability to influence change; effective and collaborative with volunteers and external stakeholders in a team environment as well as able to work autonomously
  • Sensitive to cross-cultural issues; demonstrated experience working with diverse cultures & countries

 

  • Excellent English, primary language of work (written and spoken); working knowledge of French or Spanish preferred; fluency in other international language(s) – an asset

 

  • Good computer literacy - Windows MS Office suite; also excel, access, project management

 

  • Willingness & flexibility to undertake regular travel within all WFH world regions (30-40% time)
  • Legally entitled to live & work in Quebec, Canada

Salary will be commensurate with background and experience.

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Please send in confidence an ENGLISH resume & cover letter (essential) IMMEDIATELY to:

E: ***********.**********@***.***              Fx: +1 514.875.8916

The World Federation of Hemophilia / Fédération mondiale de l'hémophilie    http://www.wfh.org

Montréal, Qc H3G 1T7 

Facebook: https://www.facebook.com/wfhemophilia        

Twitter: https://twitter.com/wfhemophilia

LinkedIn: https://www.linkedin.com/company/world-federation-of-hemophilia

YouTube: https://www.youtube.com/user/WFHcommunications  

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We thank all candidates for their interest, however only short-listed candidates will be contacted. Une version française de l'affichage est disponible selon la demande.

Apply now!

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