Senior Quality Operations Specialist

Position Overview The Senior Quality Operations Specialist will serve as an individual contributor within the U.S. Pharmaceutical Distribution (USPD) Quality Team, providing quality and technical guidance to Operations. Reporting to the Director of Operations Quality, this role operates as a key contributor, independently and through project teams, to employ their knowledge and expertise to embed quality culture, reduce compliance risk, identify efficiencies, drive continuous improvement activities, and achieve business results. This role will ensure that processes, procedures, people, analytics and technology are being leveraged to maximize quality processes and compliance across the network. As an onsite technical resource, the Specialist supports high‑risk and critical events by applying experience and judgment within defined policies, influencing investigation quality standards, documentation rigor, and work prioritization, and maintaining the effectiveness of USPD’s Quality Management System (QMS) in accordance with internal policies, laws and regulations. Key Responsibilities Operations Quality Support and Collaboration – Serve as the primary Quality liaison to Operations at the Clermont DC, maintain a regular onsite presence, partner with cross‑functional stakeholders, promptly handle critical events, oversee investigation execution, and drive quality expectations. Quality System Execution and Oversight – Drive expectations for quality at the Distribution Center, create and review SOPs and Work Instructions, ensure compliance with DSCSA and National Standards, support investigations and CAPAs, translate data into actionable recommendations, and identify system or procedural improvements. Technical Resource Role – Act as SME in documentation management, change control, investigations, CAPAs, regulatory inspection management, validation, eQMS, data integrity, and quality coaching; partner with the site Director for training delivery. Audit and Inspection Readiness – Support audit and inspection readiness, assist with preparation, post‑inspection activities, and participate in regulatory inspections, supplier/customer audits, and internal assessments. NOTE: This is not an all‑inclusive list. Other duties may be required based on business need. Minimum Requirements Bachelor’s degree in a scientific, technical, or quality‑related field (advanced degree preferred). 7+ years of relevant experience in regulated pharmaceutical distribution or related field. Critical Skills 7+ years progressive experience in pharmaceutical/medical device quality or regulated distribution. Knowledge of cGMPs and Good Distribution Practices; at least 3 years in a QA role. Experience in a large matrixed organisation, cross‑functional exposure, and ability to lead initiatives independently. Excellent written and verbal communication; strong decision making, judgment, and influence without formal authority. Proficiency in using electronic Quality Management Systems (TrackWise, MasterControl, etc.). Specialized Knowledge & Skills Knowledge of FDA regulations applicable to pharmaceutical distribution (21 CFR, DSCSA, temperature excursion standards). Experience in CAPA development, quality system enhancements, inspection readiness, and regulatory‑aligned investigation. Demonstrated analytical, problem‑solving, and data interpretation abilities in a regulated environment. Practical expertise with eQMS workflows, documentation standards, data integrity, and user enablement. Working Conditions Routine onsite presence required in office and distribution center environments. Interaction with warehouse operations as needed. Travel domestically overnight up to 20% of the time. General office work (computer use) and occasional refrigerated environments. Compensation Target salary: $128,000 – $130,000 plus a 20% bonus. Base pay range: $98,300 – $163,900. Equal Employment Opportunity Statement McKesson is an Equal Opportunity Employer and 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. McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers, including those with disabilities. For reasonable accommodations, contact View email address on click.appcast.io. #J-18808-Ljbffr McKesson’s Corporate