Job Details

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.

Job Summary

Reporting to the Sr. Manager, Quality – 3PL and QA Consulting (MSD), the Sr. Compliance Specialist will provide quality and regulatory support to the AMEGA Health activities within Private Labels and MSD (McKesson Specialized Distribution).

Section A – Specific Responsibilities

• Perform label reviews to ensure compliance with the pertinent regulation for drugs (Rx/OTC), NHP, and Medical Devices; and internal McKesson Standards

• Liase with internal and external partners to establish Quality Assurance Agreements including performing the negotiation, review, and editing

• 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

• Perform the self-inspection of AMEGA Health activities as required

• Perform the logging, review, and investigation of product complaints, as well as the reconciliation of reportable events with contract partners

• Provide quality assurance support for the maintenance of any Standard Operating Procedures (SOPs) and Work Instructions pertaining to AMEGA Health processes.

• Coordinate and document product recalls as applicable

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

• Identify, and help to action any compliance risks associated with AMEGA Health activities

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

• Maintain key compliance indicators (KCI) and/or key performance indicators (KPI) on above processes and present results to upper management if required.

• Any other compliance duties for AMEGA Health as determined by the Sr. Manager, Quality Assurance.

Section B – General Responsibilities

• Maintain relevant industry knowledge and completes required training as required

• Act as a McKesson ambassador of corporate values.

Section C – Position 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

• Bachelor's Degree in Life Sciences/Science (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 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

• Ability to travel up 20% of the time.

• #LI-JT2

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. 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

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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