Quality Operations Specialist

McKesson•Lakeland, FL

2d•Onsite

About The Position

The 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 Senior Manager of Quality Operations, 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 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 Quality Operations Specialist supports the Senior Manager of Quality Operations in maintaining the effectiveness of USPD’s 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 cross‑functional partners without formal people‑management responsibility. Success in this role requires demonstrated expertise in regulated pharmaceutical distribution, strong analytical judgment, and effective collaboration across multiple internal and external stakeholders in a highly matrixed environment. This is an onsite role located in Lakeland, FL (i.e. the Lakeland Pharma / FDC).

Requirements

Degree or equivalent and typically requires 4+ years of relevant experience.
Bachelor’s degree in a scientific, technical, or quality‑related field. Equivalent experience will be considered.
3 - 5 years of progressive experience in pharmaceutical / medical device quality, or regulated distribution environments.
Knowledge of cGMPs and Good Distribution Practices with a minimum of 2 years in a Quality Assurance role.
Experience working in a large, matrixed organization with cross‑functional 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.
Ability to work effectively and professionally with internal and external personnel as a Quality ambassador.
Excellent decision making and judgment capability.
Ability to influence without formal authority.
Ability to follow established procedures and instructions.
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>).
Demonstrates analytical, problem‑solving, and decision‑making skills, including interpretation of data and regulatory standards to support sound and regulatory‑defensible conclusions.
Experience contributing to CAPA development and execution, quality system enhancements, inspection readiness activities, and execution of regulatory‑aligned 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.
Supports development and implementation of policies and procedures related to regulated activities in the distribution centers.
Oversees the development and implementation of corrective action plans in response to findings from audits and other monitoring activities.
Provide guidance in preparation for and during inspections by governmental agencies and monitors, and developing remediation plans.

Nice To Haves

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

Responsibilities

Serve as the primary Quality liaison to Operations at the Lakeland DC
Maintain a regular onsite presence to foster a culture of quality, compliance, and collaboration
Partner with cross‑functional 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 cross‑functional input as needed to support timely and effective resolution
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
Acts as a technical and process expert for less‑experienced colleagues, providing guidance during critical events, and offering direction as appropriate without formal people‑management responsibility
Support Operations to ensure continuous audit and inspection readiness
Assist with inspection preparation activities and post‑inspection responses as assigned
Participate in and support regulatory inspections, supplier/customer audits, and internal assessments as needed