Spécialiste, Système qualité Corporative - Ententes qualité / Specialist, Corporate Quality Systems - Quality Agreement (21 month contract)

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care.

What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow's health today, we want to hear from you.

Rsum du Poste
Relevant du Responsable des Systmes de Qualit d'Entreprise, le Spcialiste des Systmes de Qualit d'Entreprise - Ententes de Qualit, jouera un rle crucial dans le maintien et l'amlioration du processus des ententes qualit . Le titulaire du poste sera charg de soutenir la cration de contrles de changement, de dviations, de CAPA, etc. lorsque cela est applicable.

Le Spcialiste des Systmes de Qualit d'Entreprise sera responsable de garantir l'adquation des oprations aux BPF (Bonnes Pratiques de Fabrication) et de veiller ce que les activits d'amlioration continue soient tablies, surveilles et maintenues pour assurer la conformit toutes les rglementations applicables, aux SOPs (Procdures Oprationnelles Standard) et la politique de l'entreprise pour les units commerciales de marque propre et de gros de Mckesson.

Responsabilits Spcifiques

• Propritaire du processus des ententes qualit .
• Dvelopper et rviser les ententes qualit : Collaborer avec les parties prenantes internes et les partenaires externes pour laborer et rviser les ententes de qualit qui dfinissent les exigences, responsabilits et attentes en matire de qualit pour les deux parties.
• valuer les processus et systmes actuels des ententes qualit : valuer les processus et systmes existants des ententes qualit pour identifier les domaines moderniser et amliorer. Dterminer comment les solutions technologiques peuvent tre utilises pour rationaliser les processus, accrotre l'efficacit et amliorer le processus de livraison des ententes qualit
• Collaborer avec des quipes interfonctionnelles pour laborer des stratgies de modernisation du systme et des processus ententes qualit . Identifier et prioriser les domaines amliorer, dvelopper des plans de mise en uvre et superviser l'excution des initiatives de modernisation spcifiquement cibles pour les ententes qualit
• Assurer la conformit : Veiller ce que les ententes qualit soient conformes aux exigences rglementaires, aux normes de l'industrie et aux politiques de l'entreprise. Surveiller et valuer en continu l'adhrence aux normes de qualit convenues.
• valuer la conformit des fournisseurs : valuer la performance qualit des fournisseurs via le processus d'valuation de gestion des fournisseurs pour les fournisseurs identifis.
• Soutenir les ngociations de contrats : Collaborer avec les quipes juridiques et commerciales pour fournir une expertise en assurance qualit lors des ngociations de contrats, en veillant ce que les exigences de qualit soient adquatement abordes dans les ententes.
• Agir en tant que point de contact principal pour la cration/modification des ententes qualit
• Fournir des conseils en matire de qualit : Agir en tant qu'expert en matire d'assurance qualit concernant les ententes qualit. Fournir des conseils et un soutien aux parties prenantes internes et aux partenaires externes pour garantir la conformit aux exigences de qualit et aux demandes d'audit requises.
• Organiser et coordonner des runions avec les fournisseurs. Communiquer avec les parties prenantes internes/externes pour rsoudre les problmes lis aux ententes qualit
• Effectuer des revues trimestrielles des accords de qualit pour valuer l'tat du processus des ententes qualit
• Crer et maintenir un tableau de bord complet, compiler les donnes des KPI, effectuer des analyses de tendances et crer des rapports applicables lis aux ententes qualit
• Fournir des donnes aux managers et directeurs pour la prparation des rapports mensuels/trimestriels des systmes de qualit, y compris les problmes de qualit, les mtriques et le rsum de tout problme de qualit.
• Initier le contrle des changements, les dviations, et les actions correctives et prventives (CAPA), lorsque cela est applicable.
• Assister au processus d'valuation des risques.
• Participer la formation annuelle sur les BPF (Bonnes Pratiques de Fabrication).

Responsabilits Gnrales

• Participer la cration et la rvision des Procdures Oprationnelles Standard (SOP) et des Instructions de Travail (IT).
• Participer la prparation des inspections de Sant Canada et des inspections corporatives, ainsi qu' la cration de plans d'actions correctives et prventives.
• Assurer la conformit de la formation BPF (Bonnes Pratiques de Fabrication).
• Soutenir ou diriger des projets et des missions spciales selon les besoins.
• Rester jour sur les changements rglementaires et techniques au sein de l'industrie.

Exigences Cls du Poste

• Baccalaurat en Sciences en Chimie, Biologie ou dans un domaine connexe
• 5 ans d'exprience professionnelle dans l'industrie pharmaceutique en Assurance Qualit
• Connaissance approfondie des rglements BPF de Sant Canada, y compris ceux appliqus aux mdicaments, dispositifs mdicaux, produits alimentaires ainsi qu'aux grossistes et distributeurs/importateurs.
• Gestion de la documentation, systme de qualit, gestion des accords de qualit (QAA).
• Exprience avec un systme de gestion de la qualit lectronique dans une fonction d'assurance qualit tablie au sein des industries pharmaceutiques/soins de sant.
• Connaissance de la Suite Microsoft : Outlook, Word, Excel et PowerPoint, ERP
• Bilingue (anglais et franais, parl et crit).
• Excellentes comptences en organisation et en gestion du temps avec la capacit de grer plusieurs projets la fois.
• Minutieux et orient vers les dtails.
• Solides comptences analytiques, excellentes comptences interpersonnelles et en communication crite et orale.
• Proactif et excellent joueur d'quipe.
• Capacit travailler de manire autonome et prendre des dcisions bases sur le jugement et l'intgrit.
• Travaille bien sous pression.
• Familiarit avec les systmes et outils de gestion de la qualit
• Une certification en assurance qualit ou dans un domaine connexe (par exemple, Auditeur Qualit Certifi) peut tre bnfique.

Le.la titulaire de ce poste aura soutenir de faon quotidienne des clients internes et/ou externes l'extrieur du Qubec et/ou aux tats-Unis. Par consquent, ce poste requiert une matrise de l'anglais l'crit et l'oral. Veuillez noter que le nombre de postes dont les tches requirent une connaissance de la langue anglaise a t restreint dans la mesure du possible.

Job Summary

Reporting to the Corporate Quality Systems Manager, the Corporate Quality Systems Specialist - QAA, will play a critical role in the maintenance and improvement of the Quality Agreements process. The incumbent will be responsible for supporting the creation of change control, deviations, CAPA, etc when applicable.

The Corporate Quality Systems Specialist will be responsible for ensuring cGMP appropriateness of operations and continuous improvement activities are established, monitored, and maintained to ensure compliance with all applicable regulations, SOPs and company for the Private label and Mckesson wholesale business units.

Specific Responsibilities

• Process owner of the Quality agreement process.
• Develop and review quality agreements: Collaborate with internal stakeholders and external partners to develop and review quality agreements that outline the quality requirements, responsibilities, and expectations for both parties.
• Assess current quality agreement processes and systems: Evaluate the existing quality agreement processes and systems to identify areas for modernization and improvement. Determine how technology solutions can be leveraged to streamline processes, enhance efficiency, and improve the process for delivering quality agreements.
• Collaborate with cross-functional teams to develop strategies for modernizing the quality agreement system and process. Identify and prioritize areas for improvement, develop implementation plans, and oversee the execution of modernization initiatives specifically targeted for quality agreements
• Ensure compliance: Ensure that the quality agreements align with regulatory requirements, industry standards, and company policies. Continuously monitor and assess adherence to the agreed-upon quality standards.
• Evaluate supplier's compliance: Evaluate the quality performance of suppliers through the vendor management evaluation process for the identified suppliers.
• Support contract negotiations: Collaborate with legal and business teams to provide quality assurance expertise during contract negotiations, ensuring that quality requirements are adequately addressed in the agreements.
• Act as of primarily point of contact for Quality Agreement creation / modification.
• Provide quality guidance: Act as a subject matter expert on quality assurance matters related to quality agreements. Provide guidance and support to internal stakeholders and external partners to ensure compliance with quality requirements and required audits requests.
• Organize and coordinate meetings with suppliers. Communicate with internal /external stakeholders to resolve QAA issues.
• Perform QAA quarterly reviews to assess status of the QAA process.
• Create and maintain comprehensive dashboard, compile KPI data, perform trends analysis and create applicable reports related to QAA.
• Provide data to Managers and Directors for preparation of monthly/quarterly Quality Systems reports including quality issues, metrics and summary of any quality problems.
• Initiate Change Control, Deviation, and Corrective Action and Preventive Action (CAPA), when applicable.
• Assists in risk assessment process.
• Participate in the GMP annual training.

General Responsibilities

• Participate in the creation and revision of Standard Operating Procedures (SOPs) and Working Instructions (WIs).
• Participate in the preparation for Health Canada and Corporate inspections along with creation of corrective action and preventive action plan.
• Ensure GMP training compliance.
• Support or lead special projects and assignments as needed.
• Remain current on regulatory and technical changes within the industry.

Position Key Requirements

• Bachelor of Sciences in Chemistry, Biology or in a related field
• 5 years of work experience in pharmaceutical industry in Quality Assurance
• Strong knowledge of Health Canada's GMP Regulations including those applied to Drugs, Medical Devices, Food products along with wholesalers and distributors/importers.
• Documentation management, Quality system, QAA management.
• Experience of electronic Quality Management System in an established QA function within pharmaceutical/healthcare industries.
• Knowledge of Microsoft Suite: Outlook, Word, Excel and Power Point, ERP
• Bilingual (spoken/written English and French).
• Excellent organizational and time management skills with ability to manage several projects at once.
• Meticulous and detail oriented.
• Strong analytical skills, excellent interpersonal and written & oral communication skills.
• Proactive and strong team player.
• Ability to work independently and make decisions based on judgment and integrity.
• Works well under pressure.
• Familiarity with quality management systems and tools
• Certification in quality assurance or related field (e.g., Certified Quality Auditor) may be beneficial.
• #LI-JT2

The incumbent of this position will provide daily support to internal and/or external clients outside Quebec and/or in the United States. Therefore, he/she must be proficient in spoken and written English. Please note that the number of positions requiring English language skills has been limited where possible.

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please click here.

Our Base Pay Range for this position

$70,600 - $117,600

McKesson is an Equal Opportunity Employer

McKesson provides equal employment opportunities to applicants and employees and is committed to a diverse and inclusive environment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age or genetic information. For additional information on McKesson's full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

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