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 Senior Manager, Corporate Quality Systems & CSV, the Senior Quality Computer Validation Specialist will be responsible for supporting validation activities for computerized equipment and software systems and may support controlled environments, ensuring adherence to the established GxP standards of quality including reliability, usability, and performance of the specific systems. The incumbent will support and collaborate with various business units requiring quality & validation activities.

At this level, the Senior Quality Computer Validation Specialist typically:

• Interacts with senior management and senior customer personnel on matters requiring validation-related coordination across organizational units.
• Represents the department on projects and may perform in a project leadership role.
• Coordinates activities with project teams, including external consultants and service suppliers.
• Supports change control evaluation, investigations, and corrective and preventative action (CAPA) activities.
• Co-ordinates with other departments and management teams to optimize validation processes.
• Provides technical support and expertise to end users and quality resources.
• Acts as a resource and mentor for colleagues with less experience; may direct the work of others without formal management responsibilities; may utilize internal or external resources to accomplish goals.
• Supports planning of, and participates in, the execution of the periodic qualification program.
• Ensures controlled and/or regulated project documents and records are initiated, advanced, completed and maintained in accordance with the Quality Management System (QMS) and relevant regulatory guidelines, including Good Manufacturing Practices (GMP).
• Tracks/monitors and provides timely, accurate information regarding status of tasks.

Section A – Specific Responsibilities

Certain responsibilities that are typically associated with a job as Senior Validation Specialist are included in Section B. Specific duties include the above and also generally include but are not limited to the following:

• Prepare and execute validation deliverables such as commissioning and/or qualification documentation, including installation, operational and/or performance qualification (IQ/OQ/PQ) systems/software and/or controlled temperature environments to meet current GMP regulations, industry guidelines & best practices and company policies.
• Write and/or review documentation including plans, specifications, risk assessments, protocols and reports, standard operating procedures (SOPs), and others if applicable according to relevant guidelines.
• Maintain key quality metrics and identify improvements.
• Draft, and lead collaboration, of quality and validation policies and procedures.
• Support the review, interpretation, and evaluation of regulatory requirements and industry best practices.
• Manage projects and support initiatives on a DC-specific, regional, or national scale.
• Create and dispense training and awareness material on validation-related topics.

Section B – General Responsibilities

• Promote understanding of quality standards and processes within the company.
• Identify training needs and organize training interventions to meet quality standards.
• Support DCs in the preparation, execution and follow-up of regulatory inspections by maintaining qualification documents and response actions.
• Practice safe work habits and adheres to company safety/security procedures and guidelines.
• Maintain Good Documentation Practices.
• Act as a key contributor in a more complex/critical environment.
• Develop resolutions to complex problems that require the frequent use of creativity.
• Use judgment within broadly defined policies and practices.
• Anticipate change and directs or redirects efforts.
• Accomplish work without considerable direction and exerts significant latitude in determining objectives of assignment.
• Anticipate change and communicates potential solutions with the management team.
• Responsible to exhibit professional behavior with internal and external associates that reflects positively on the company and is consistent with the company’s policies and practices
• Support other validation activities as required.

Section C – Position Key Requirements

Education and Experience:

• B.Sc/M.Sc or equivalent in sciences or information technologies related field with 3+ years relevant computer experience.
• Demonstrated experience in the execution of validation activities within regulated industrial pharmaceutical, information technologies, or life-sciences organizations.
• Knowledge of Canadian GMP requirements and other applicable regulations/guidelines pertaining to validation of computerized systems and controlled temperature environments.
• Strong computer skills including Microsoft Office and databases.
• Experience with development and implementation of qualification and validation programs.
• Experience with quality risk management programs.
• Experience conducting Quality investigations.
• Experience with controlled environment monitoring programs/systems, considered an asset.

Technical and Soft Skills:

• Knowledge of current regulations and best practices, including, but not limited to, GMP, PICs, Annex 11, GAMP 5.
• Strong knowledge of Health Canada's GMP Regulations including those applied to wholesalers and distributors/importers.
• Knowledge of regulations and guidelines for temperature control of drug products during storage and transportation.
• Knowledge of validation tools, concepts and methodologies.
• Knowledge of project management tools, concepts and methodologies.
• Strong analytical skills, excellent interpersonal, written & oral communication skills.
• Good judgment and decision-making.
• Ability to work independently with minimal direction
• Ability to act as a SME during internal and external audits.
• Strong time management and prioritization skills, with ability to manage multiple projects simultaneously.
• Bilingual (spoken/written English and French), considered an asset.

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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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