Senior Quality Operations Specialist (Masters)

McKesson • Memphis, TN

15d • Onsite

About The Position

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. We are seeking a Senior Quality Operations Specialist to sustain the first level Quality Program across the domestic distribution operations network. This position will support a nationwide business of finished goods by building a culture of quality excellence with a keen focus on education, proactive assessments, right-sized solution development and inspection readiness. The position will promote a Quality Management System across the domestic distribution network and report to the Director of Quality Operations. This is an onsite position located in Memphis, TN. The Senior Quality Operations Specialist is responsible for building and sustaining the operations quality management system and associated processes / procedures for a virtual wholesale distribution business (Masters). The role will ensure that processes, procedures, analytics and technology are being leveraged to maximize quality processes and compliance across the virtual wholesale distribution business. This position will also be responsible for supporting the business unit's clinical trial business (pharmaceutical comparator studies).

Requirements

• Degree or equivalent and typically requires 7+ years of relevant experience.
• 4-year degree in business or related field or equivalent experience
• Excellent written and verbal communication skills
• Strong analytical and problem solving skills
• Experience working within a highly matrixed environment
• Knowledge of FDA, DEA, State Boards of Pharmacy and other regulatory agencies
• Knowledge of wholesale distribution and/or pharmaceutical manufacturing
• Knowledge of Lean and six sigma principles
• Knowledge of Warehousing and Distribution Operations

Nice To Haves

• Technical writing experience (specifically SOP writing experience)
• Experience hosting or supporting FDA or other regulatory agency inspections
• Quality management system software experience
• Investigation and CAPA experience
• Internal audit experience
• Experience with training program management
• Comfort with ambiguity, ability to build effective working relationships with cross-functional stakeholders, and the ability to influence without authority
• Proficient in fostering collaboration with stakeholders across various businesses and work effectively in a dynamic, fast-paced environment
• Ability to manage multiple complex projects, prioritize tasks and meet tight deadlines
• Self-motivated and enthusiastic, a fast learner who can identify challenges and propose effective solutions
• Proficient in Microsoft suite of products and willingness to embrace digital transformation technologies

Responsibilities

• Create operational Standard Operating Procedures (SOPs) to enhance operational efficiency and compliance with corporate policies and regulations
• Provide training to increase working knowledge of the Quality Management System
• Establish format to assess for audit readiness
• Review and follow up on outstanding corrective and preventative actions
• Support/Host regulatory inspections as needed
• Evaluate improvement opportunities for virtual wholesale distribution operations
• Support McKesson US Pharmaceutical Distribution (USPD) Business unit as needed

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees