Commercial Quality Manager

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Shepherdsville, Kentucky, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Commercial Quality Manager to be located in Shepherdsville, Kentucky.

The Commercial Quality Manager will have responsibilities for the Quality Assurance operations at the Kentucky Distribution Center (KDC) and Franklin Distribution Center (FDC).  The Manager will serve as a single point of contact to the Sr. Manager, Commercial Quality, Deliver, and will collaborate closely with other quality functions and business partners to drive timely resolution of quality operational related issues.

Key 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 proces