Détails du poste

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Job Summary

Reporting to the Post-Market Manager, Private Label, the Post-Market Senior Specialist, Private Label 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 policies for the Private Labels and Mckesson wholesale business units, specifically for medical devices.

The Sr. Post-Market Specialist, Private Label will be responsible for the creation and tracking of complaints and recalls. The incumbent will be responsible for supporting the creation of change control, deviations, CAPA, etc.

Section A – Specific Responsibilities

• Process owner of the complaint and product inquiry.

• Participate in complaint handling and recall processes harmonization.

• Collaborate with the Pharmacovigilance, Customer Service teams and all appropriate internal departments.

• Communicate with internal /external stakeholders to resolve quality issues and escalate issues when needed.

• Collaborate on recall processes.

• Support Automation processus implementation to ensure compliance with the pertinent regulation for medical devices.

• Support AMEGA Health business:

  • Perform label reviews to ensure compliance with the pertinent regulation for Medical Devices; and internal McKesson Standards.

  • Provide quality and regulatory assurance guidance to AMEGA Health for new product launches, specifically pertaining to product labelling, importation/licensing, and medical device classifications.

  • Responsible for performing the product release functions for incoming AMEGA Health shipments including but not limited to: review of receiving documents, temperature data, product labels, and GMP documents as applicable

  • Provide support to Corporate Quality and Excellence teams for audit related preparation as it pertains to AMEGA Health products

  • Responsible to maintain the vendor assessment and qualification status of any AMEGA Health suppliers including performing audits when appropriate.

  • Support any deviation, change control, CAPA related to AMEGA Health products and performing the periodic trending accordingly.

• Serve as a back-up person in case of the absence of any PV&MI team member to ensure the continuity of daily activities.

• Serve as a back-up person in case of the absence of Manager, Post-Market Private Label if a Subject Matter Expert (SME), to ensure the continuity of daily activities.

Section B – General Responsibilities

• Participate in the creation and revision of Standard Operating Procedures (SOPs) and Working Instructions (WIs).

• Participate on complaint reconciliation with applicable suppliers.

• Write quarterly complaint trend report reports and communicate in a timely manner finding related to documentation issues including but not limited to delays in receiving documentation from suppliers, investigations etc.

• Compile KPI data to perform trends analysis and create applicable reports.

• Provide data to applicable teams for preparation of monthly/quarterly reports including quality issues, metrics and summary of any quality problems.

• Ensure GMP training compliance.

• Support or lead special projects and assignments as needed.

• Remain current on legislative, regulatory and technical changes within the industry.

• Other related duties appropriate to experience and expertise.

Section C – Position Key Requirements

Working Experience

• Minimum of 7 years of relevant experience

• Minimum of 4 years of experience in Quality Assurance/Compliance, specifically in the product area of Medical Devices

• Working experience in Quality/Assurance/Compliance for drugs (OTC/Rx) and with private label NHPs, is an asset.

Education

• University Degree in Life Sciences/Science or equivalent (Post graduate degrees and Health Professional degrees are preferred).

Personal Development and Soft Skills

• Ability to work independently and as a member of a team.

• Excellent written and verbal communication skills

• Able to manage multiple projects and deadlines

• Ability to identify compliance risks.

Technical Skills

• Proficiency with computer applications such as Word, Excel, PowerPoint, and Outlook

• Working experience in applying and communicating complex regulations for Natural Health Products (NHPs) and Medical Devices

• Ability to interpret complex Regulatory documents such as Health Canada guidance documents in order to provide guidance to internal and external stakeholders.

Other Skills and Capabilities

• Ability to multi-task and to work in a fast-paced environment

• Attention to detail

• Strong organizational skills

• Strong troubleshooting and critical analysis skills

• Strong time management skills.

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Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.

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

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McKesson provides equal employment opportunities to applicants and employees, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other legally protected category. For additional information on McKesson’s full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

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