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 The Senior Specialist, Quality Computer Validation supports the validation and ongoing compliance of GxP computerized systems, software, computerized equipment and, where required, controlled-temperature environments. Reporting to the Senior Manager, Corporate Quality Systems & CSV, you will partner with business units, project teams, consultants and service providers to deliver risk-based validation activities in accordance with the Quality Management System, Good Manufacturing Practices and applicable regulatory expectations. You will provide technical expertise, lead validation workstreams and help strengthen reliable, usable and compliant systems across the organization. Responsibilities Lead or support computer system validation and qualification activities across the system lifecycle, including new implementations, upgrades, changes and periodic reviews. Author, review and execute validation deliverables, including validation plans, user and functional requirements, specifications, risk assessments, test protocols, traceability documentation and summary reports. Prepare and execute installation, operational and performance qualification documentation (IQ/OQ/PQ) for computerized systems, software, equipment and applicable controlled-temperature environments. Assess change controls, deviations, investigations and corrective and preventive actions (CAPA), and document validation impact and follow-up actions. Ensure regulated project records are complete, accurate and maintained in accordance with the Quality Management System, Good Documentation Practices, GMP and applicable regulatory guidance. Coordinate validation activities with cross-functional project teams, distribution centres, external consultants and service providers; communicate status, risks and recommendations to stakeholders. Improve validation procedures, quality metrics, training materials and inspection readiness, while providing guidance and mentorship to colleagues with less validation experience. Other duties may be assigned as needed to meet Company goals. Basic Requirements Degree or equivalent and typically requires 7+ years of relevant experience. Post-secondary degree in science, computer science, information technology or a related field. Demonstrated experience executing computer system validation activities in a regulated pharmaceutical, life sciences or similarly GxP-regulated environment. Experience authoring and executing validation lifecycle documentation, such as plans, requirements, risk assessments, protocols, test scripts, traceability documentation and reports. Experience with change control, deviations or investigations, CAPA and quality risk management within a Quality Management System. Working knowledge of GMP requirements and computerized system validation principles, including GAMP 5 and EU GMP Annex 11. Experience supporting audits or regulatory inspections as a validation or quality subject-matter resource. Experience with ERP systems such as SAP. Preferred Skills/Experience Knowledge of Health Canada GMP requirements applicable to drug wholesalers, distributors or importers, and guidance for temperature-controlled storage and transportation. Experience with controlled-temperature environments, monitoring systems, periodic qualification programs or pharmaceutical distribution operations. Bilingual communication skills in English and French, and experience coordinating multiple validation projects or third-party suppliers. #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. 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 $99,100 - $132,100 McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson’s (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind: McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application. McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates. McKesson job postings are posted on our career site: careers.mckesson.com. McKesson is an Equal Opportunity Employer 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. McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to (United States) Disability_Accommodation@McKesson.com or (Canada) Accessibility@mckesson.ca. Resumes or CVs submitted to this email box will not be accepted. Join us at McKesson! 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.

Senior Specialist, Quality Computer Validation (18 month contract).

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