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

November 4 2020
Industries Healthcare, social assistance
Categories Production, Operations, Quality, Safety, Transport, Logistics, Supply Chain, Purchasing, Engineering, Pharma, Biotech, Sciences, R&D, Scientific and Regulatory affairs, Quality assurance and control, Validation, Supply chain, Purchasing, Logistics, Distribution, Shipping
Montreal, QC

****Description en anglais seulement  (langue du travail au quotidien sur la scène internationale) - Une version française de l'affichage est disponible selon la demande.****

The WFH is currently seeking a self-startinghighly knowledgeable & results-oriented COMPLIANCE SPECIALIST (contract 1 yr, renewable) to support the logistics & distribution activities of the Humanitarian Aid (HA) department relating mainly to shipping, storage, and distribution of donations of hemophilia treatment products to recipients countries in the developing world according to the WFH annual donation plan.. 

Type of position: full-time; CONTRACT  1 year (possibility of permanence, extension)

Location: Montreal downtown / Covid-19 home-based currently

Start Date: AS SOON AS POSSIBLE  (latest: early Jan 2021)

Apply: recrutement.recruting@wfh.org

SUMMARY –

Reporting to the Director, Medical & Humanitarian Aid, the COMPLIANCE SPECIALIST, Humanitarian Aid (HA) is responsible for ensuring that the WFH export & 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 - notably adherence to General Distribution Procedures (GDPs). 

The incumbent ensures that all document requirements & 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,  to ensure compliance with all applicable rules, regulations and WFH contractual obligations.

The documentation Compliance Specialist partakes as need be, in the preparation & presentation of content for compliance training of personnel in recipient countries – ex.,  importation, transportation, storage, utilization, and reporting on hemophilia donated products.

The incumbent also travels as necessary (post Covid-19 restrictions) to recipient countries to make assessments and participate in evaluations on capabilities & readiness to receive donations of hemophilia and bleeding disorders treatment products.

PRINCIPAL DUTIES & RESPONSIBILITIES –

  • Develop & 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, other
  • Upkeep & maintain the quality management system (QMS): 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 & evaluate on an ongoing basis, the effectiveness & efficiency of the HA donation program and its operations, the adequacy of its internal documentation, as well as the controls and safeguards, relative to pharmaceutical compliance, applicable laws, and WFH contractual obligation
  • Carry out investigations of any compliance incidents and suggest corrective & preventive actions.
  • Plan & perform internal 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 & management actions.
  • Monitor quality standards, make recommendations for improvement, corrective actions, and design preventive actions as need be. 
  • Develop operational validation and quality-based procedures.
  • Perform site visits as need be (post Covid-19 restrictions) to recipient countries of HA donations to validate SOPs, test procedures, train personnel.
  • Partake as necessary in regional workshops or in-country training (currently virtual) 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.

QUALIFICATIONS & REQUIREMENTS –

  • Bachelor's degree in engineering, science, or other relevant discipline – including QA certification 
  • Min. of five (5) years of relevant working experience in pharmaceutical sector, including 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; subject-matter expert capable of working autonomously or in teams
  • Strong interpersonal and communication skills, with ability to influence change; effective and collaborative with volunteers and external stakeholders; sensitive to cross-cultural issuesdemonstrated experience working with diverse cultures countries
  • Excellent oral & written communication skills in English (essential to daily WFH international work); working knowledge of French and Spanish preferred; knowledge of other world language/s - an asset
  • Good computer literacy - Windows MS Office suite; also excel, access, project management
  • Willingness & flexibility to undertake regular travel (post Covid-19 restrictions) within all WFH world regions (30-40% time)
  • Legally entitled to live & work in Quebec, Canada

Salary will be commensurate with background and experience.

Please send IMMEDIATELY in full confidence, an ENGLISH resume & short cover letter (deadline: November 6) to:

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

Fédération mondiale de l'hémophilie / The World Federation of Hemophilia  -  http://www.wfh.org
Montréal, Québec  H3G 1T7  Canada
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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       

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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