Senior Quality Operations Specialist

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 tomorrows health today we want to hear from you.

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.

The Senior Quality Operations Specialist provides direction during high-risk and critical events that may have potential impact to product by applying their experience and judgement within defined policies. This individual will also influence investigation quality standards documentation rigor and work prioritization to promote consistent application of internal procedures and applicable regulatory requirements.

In addition the Senior Quality Operations Specialist supports the Director Operations Quality in maintaining the effectiveness of USPDs Quality Management System (QMS) in accordance with internal policies and applicable laws and regulations including preparedness for emerging regulatory and operational changes. This role serves as an onsite technical resource to operational colleagues and crossfunctional partners without formal peoplemanagement responsibility. Success in this role requires demonstrated expertise in regulated pharmaceutical distribution ability to apply cGMP concepts (as appropriate) to varying types of supply chain operations strong analytical judgment and effective collaboration across multiple internal and external stakeholders in a highly matrixed environment.

This is an onsite role located in Shepherdsville KY (i.e. the Clermont Specialty DC).

Compensation: Target salary for this role is between $128000 and $130000 along with a 20% bonus.

Key Responsibilities

Operations Quality Support and Collaboration

• Serve as the primary Quality liaison to Operations at the Clermont DC

• Maintain a regular onsite presence to foster a culture of quality compliance and collaboration

• Partner with crossfunctional stakeholders to address operational quality needs and risks

• Promptly escalate critical events while planning the investigative approach based on event risk urgency resource availability and potential business impact

• Oversees critical investigation execution coordinating crossfunctional input as needed to support timely and effective resolution

Quality System Execution and Oversight

Drive expectations for quality at the Distribution Center (DC) including but not limited to:

• Create review and/or edit Standard Operating Procedures (SOPs) and Work Instructions (WIs) to enhance operational efficiency and compliance with corporate policies and regulations

• Ensure operational compliance with DSCSA and implementation of National Standards

• Supports the administration and completion of operational investigations while coaching teams on root cause analysis tools and the appropriate development and implementation of CAPAs to ensure regulatory defensibility.

• Translates investigation data trends and business drivers into actionable recommendations that improve investigation outcomes and inspection readiness

• Identifies operational pain points and emerging risks and translates them into system or procedural improvements while maintaining operational efficiency

Technical Resource Role

Serve as the Subject Matter Expert (SME) in the following areas:

• Documentation Management / Version Control / Good Documentation Practices

• Change Control

• Investigations / Root Cause Analysis

• Corrective and Preventive Actions (CAPAs)

• Regulatory Inspection Management

• Validation

• Electronic Quality Management Systems (e.g. TrackWise and MasterControl)

• Data Integrity

Quality Leadership Coaching & Knowledge Development

• Partners with the site Director of Operations to support training delivery to enhance Operations understanding and application of Quality principles and requirements

• Acts as a technical and process expert for lessexperienced colleagues providing guidance during critical events and offering direction as appropriate without formal peoplemanagement responsibility

Audit and Inspection Readiness

• Support Operations to ensure continuous audit and inspection readiness

• Assist with inspection preparation activities and postinspection responses as assigned

• Participate in and support regulatory inspections supplier/customer audits and internal assessments as needed

NOTE: This is not an all-inclusive list. Other duties may be required based on business need.

Minimum Requirement

Degree or equivalent and typically requires 7 years of relevant experience.

Education

Bachelors degree in a scientific technical or qualityrelated field. Advanced degree preferred.

Critical Skills

• 7 years of progressive experience in pharmaceutical / medical device quality or regulated distribution environments.

• Knowledge of cGMPs and Good Distribution Practices with a minimum of 3 years in a Quality Assurance role.

• Experience working in a large matrixed organization with crossfunctional exposure to Quality Operations Compliance Technology and external partners.

• Ability to conduct complex initiatives in a self-directed manner with minimal oversight and to deliver superior results in a timely manner.

• Must have excellent written and verbal communication skills to effectively communicate and influence a broad spectrum of business segment personnel and senior management.

• A superior level of professionalism to work effectively with internal and external personnel.

• Excellent decision making and judgment capability.

• Ability to influence without formal authority.

• Ability to follow established procedures and instructions.

Specialized Knowledge & Skills

• Knowledge of FDA regulations and requirements applicable to pharmaceutical distribution including the Code of Federal Regulations (21 CFR) Drug Supply Chain Security Act (DSCSA) and industry standards for temperature excursion management (e.g. USP <659> USP <1079>).

• Experience working in pharmaceutical or medical device manufacturing.

• Demonstrates analytical problemsolving and decisionmaking skills including interpretation of data and regulatory standards to support sound and regulatorydefensible conclusions.

• Experience contributing to CAPA development and execution quality system enhancements inspection readiness activities and execution of regulatoryaligned investigation and documentation practices.

• Practical expertise working within an electronic Quality Management System (eQMS) including supporting investigation workflows documentation standards user enablement and data integrity.

• Excellent prioritization skills to manage complex investigations and quality initiatives within a regulated environment.

Working Conditions

Environment (Office warehouse etc.)

• Routine onsite presence required in an office and distribution center environment.

• Interaction with warehouse operations as needed to support quality activities.

• Ability to travel domestically overnight 20% of the time.

Physical Requirements (Lifting standing etc.)

• General office requirements including extended periods of computer and keyboard use.

• Access to warehouse environment and activities as needed.

• Ability to attend virtual meetings and training sessions.

• Ability to work in refrigerated environments for short periods of time to support quality activities.

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 McKessons 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 pleaseclick here.

Our Base Pay Range for this position

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