Commercial Quality Manager

Johnson & Johnson Innovative Medicine•Shepherdsville, KY

2d•Onsite

About The Position

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.

Requirements

A minimum of a bachelor’s degree is required. A degree in Engineering, Scientific, Business, or Quality Regulatory Compliance subject area is preferred.
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.

Nice To Haves

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

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.