Job Description

McKesson requires new employees to be fully vaccinated for COVID-19 as defined by Health Canada, subject to applicable, verified accommodation requests.

McKesson is in the business of better health, and we touch the lives of patients in virtually every aspect of healthcare. At McKesson Canada, we touch the lives of 12 million Canadians every day. We carry more than 35,000 products in 12 distribution centers and ultimately provide distribution to 6,300 retail pharmacies, 1,350 hospitals, long-term care centers, clinics and institutions all over Canada. But we're so much more than a distribution company. We've automated 2,500 retail pharmacies and dispense over 100 million doses a year through our automation solutions. Manufacturers, healthcare providers and patients count on us for a full range of services that contribute to the quality and safety of care for us all.

At McKesson Canada, you'll help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that's vital to us all.

Summary

This position is responsible for implementing the McKesson Specialty Health (MSH) quality management system activities and compliance with business processes based on established procedures, relevant regulations and industry guidelines. This position is responsible in effectively understand cross-functional process and conduct thorough analysis of quality
initiatives and their impact on the overall MSH business prior to implementation. In addition, this position is responsible for communicating with the Manager, Quality Patient Support Programs and key business stakeholders with regards to any audits, trends, or matters that affect the MSH business unit. The position will also work closely with the Quality Specialists
to ensuring compliance with corporate, client, and regulatory requirements.

Specific Responsibilities

• Take responsibility for overseeing, planning, and performing and business process compliance auditing activities.
• Identify compliance risks and bringing to the attention of management.
• Design, recommend, and implement changes to processes and systems.
• Regularly monitors and evaluates activities to identify potential risks and non-compliances.
• Control the process for authoring, review, approval and subsequent distribution, archiving and destruction of controlled documents (SOPs, GD's, Wl's, Reports and other GxP documents).
• Describe and govern the system to ensure GxP documentation and records are managed in accordance with Global Quality requirements, regulations and client requirements.
• Support with external audits and post audit activities.
• Conducts root cause analysis and evaluation of CAPAs for non-conformances to procedures.
• Conducts analysis and prepares metrics reports on compliance with quality management systems (i.e., tracking document status, documents approaching expiration, volume of reviews, review time, training completion, etc), as well as status of deviations and CAPA.
• Coordinate, plan and execute scheduled self-inspections in accordance with applicable Standard Operating Procedure(s) and work instructions. Issue internal audit reports and follow up on CAPA/commitments.
• Ensure offsite records storage for Quality Department documentation is aligned and managed within the policies and procedures of the document management system and are integrated with the life cycle approach to the GxP related documents.
• Review applicable Change Control documents to ensure referenced changes are identified and are compliant.
• Regularly monitors and evaluates activities to identify potential risks and non-compliances.

General Responsibilities

• Function as the Subject Matter Expert (SME) on applicable Regulations.
• Provide technical and regulatory guidance with regard to regulations and external stake-holders to ensure overall quality and compliance.
• Makes continuous recommendations for procedural improvements and problem solve to improve procedures by providing recommendations.
• Keep current of updates to applicable Regulations

Requirements

• Post-secondary education (University degree preferred) in business, operations management, science, engineering or related areas preferred.
• Four to six years' experience and understanding of quality in the pharmaceutical/health care industry.
• Thorough knowledge of cGxPs, regulatory, and compliance requirements are required.
• Ability to work independently and work well with others and must spend a significant amount of time working with the operations team to understand processes.
• Advanced knowledge of risk and compliance methodologies and processes. This involves strategizing, planning, managing, writing, and/or reviewing the activities and documents.
• Knowledge and competencies in document management software applications and solutions, including experience or training in document management system.
• Strong customer focus and ability to prioritize and adapt to business needs.
• Ability to communicate and work with a broad spectrum of professional and technical staff to effectively manage documents and records in an efficient and practical manner.
• Experience interacting with regulatory agencies and health authority inspections.
• Excellent organizational, interpersonal and leadership/teamwork abilities.
• Good presentation and problem-solving skills, and ability to make decisions.
• Proven leadership and interpersonal skills.
• Ability to communicate and gain commitment at all levels of the organization.
• Ability to efficiently present key elements of a project in relation to the audience's need.
• Ability to proof-read, edit with strong technical writing skills.
• Strong analytical skills and ability to synthesize.
• Strong collaboration mindset enabling efficient communication between different groups, departments.
• Strong written and oral communication skills.
• Ability to work independently and problem solve.

Career Level - IC - Professional - P3

Worker Type Regular

McKesson is an Equal Opportunity employer.

The material contained herein is provided for informational purpose only. All open jobs offered by McKesson on this recruitment system are subject to specific job skill requirements. The job skill requirements, qualifications, and preferred experience are determined by a subsidiary, office or department within the company which is offering the position, and all positions are subject to local prevailing employment laws and restrictions. This would include immigration laws pertaining to work authorization requirements and any other applicable government permissions or compliance.

The materials on this site are provided without warranties of any kind, either expressed or implied, including but not limited to warranties regarding the completeness of information contained on this site or in any referenced links. While McKesson attempts to update this site on a timely basis, the information is effective only as of the time and date of posting.

McKesson is an equal opportunity employer and values diversity in its workforce. We encourage applications from all qualified individuals and will accommodate applicants' needs, up to the point of undue hardship, throughout all stages of the recruitment and selection process.

The information on this site is for information purpose only and is not intended to be relied upon with legal consequence.

Current employees must apply through internal career site.

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