Johnson & Johnson Innovative Medicine · 14 hours ago
Commercial Quality Manager
Shepherdsville, KY
Full-time
Onsite
Senior Level
6+ years expJohnson & Johnson is a leader in healthcare innovation, dedicated to improving health for humanity. They are seeking a Commercial Quality Manager to oversee Quality Assurance operations at their distribution centers, driving compliance and continuous improvement initiatives to ensure product quality and regulatory adherence.
Pharmaceuticals
Responsibilities
Drives innovation within functional areas while ensuring functional initiatives are delivered in a compliant and safe manner
Identifies opportunities to continuously improve quality, cost, and time factors, consistent with both Commercial Quality and DELIVER Supply Chain business objectives
Identify business opportunities, communicate with management, prioritizes for action, and leads improvement in collaboration with other Supply Chain partners
Responsible for oversight of pack/label and inspection activities at distribution centers (KDC & FDC), including flawless execution of batch record review and approval
Responsible for audit inspection readiness activities at KDC and hosting Health Authority and Regulatory Inspections including, but not limited to, TSA, DEA, FDA, NABP and PIC
Responsible for supporting internal and external audits, including scheduling, planning, conducting, and follow-up activities for Kentucky Distribution Center (KDC)
Responsible for adherence to the deviation, corrective and preventative action (CAPA), change controls processes and quality management systems. Additionally, responsible for review and approval of mentioned records
Responsible for adherence to the records management retention processes, the training process and quality agreement process
Responsible for providing quality and compliance oversight for execution of protocols
Responsible for notifying/escalating critical quality issues to management in a timely manner
Responsible for the support of New Product Launch activities at the distribution center including master data (sIDMa) set-up
Responsible for ensuring compliance and remaining current with local, state, federal, and international regulations and standards
Responsible for evaluating overall compliance risk, recommending, implementing corrective actions, and tracking progress
Responsible for making quality decisions based upon assessments of compliance risks balanced with the overall business needs
Responsible for monitoring of material destruction authorization (MDA) process
Oversight of product receiving process within the distribution centers as well as disposition of damaged packages (incoming & outbound) following the established procedures or predefined agreements
Responsible for returned and/or refused product disposition according to procedures or predefined agreements
Responsible for the compliance of rework or special inspection operations conducted at the distribution centers
Responsible for performing gap assessments in local procedures to Johnson and Johnson Global Standards, Business processes, and External Standards and to remediate gaps
Raising all appropriate issues to the Sr. Manager CQ Deliver or appropriate Business Partners
Responsible for supporting the 24/7 operations of the Distribution Center
Provide overall direction, coordination, and evaluation of a driving team that put customer centricity first
Serve as mentor in the areas of people development, skill development and career development
Other duties, as assigned
Qualification
Required
A minimum of a bachelor's degree is required
A minimum of 6 years of experience in Medical Device, Pharmaceutical, or Consumer products industry
Work experience in a highly regulated industry and a solid understanding of FDA 21 CFR Part 210, 211, ISO 9001 and/or ISO 13485
Proven experience leading projects and influencing team members to achieve results without direct supervision
Strong written and verbal communication skills, the ability to take initiative independently as well as collaborate as part of a team
Proven problem solving, decision-making, data analysis, inductive reasoning, critical thinking and root cause analysis skills
Excellent communication and presentation skills
Strong change management, collaboration and influencing skills to partner effectively across functions
Ability to work under tight timelines and be customer focused and oriented
Must be able to manage/provide leadership to multiple sites
People management experience
This position may require up to a 20% of domestic travel
Preferred
A degree in Engineering, Scientific, Business, or Quality Regulatory Compliance subject area is preferred
Coaching
Compliance Management
Continuous Improvement
Corrective and Preventive Action (CAPA)
Distribution Center Operations
Performance Measurement
Process Improvements
Quality Assurance (QA)
Quality Management Systems (QMS)
Quality Standards
Regulatory Environment
Stakeholder Engagement
Standard Operating Procedure (SOP)
Technical Credibility
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
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