Commercial Quality Manager

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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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 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 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.

Qualifications

Education:

• A minimum of a bachelors degree is required. A degree in Engineering Scientific Business or Quality Regulatory Compliance subject area is preferred.

Experience and Skills:

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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please contact us via or contact AskGS to be directed to your accommodation resource.

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