Area Quality Manager - Healthcare

We are looking for a Regional Continuous Improvement Black Belt to spearhead the Continuous Improvement projects in the Southeast region. If you have successful 3PL (Third-party Logistics) industrial or continuous improvement engineering experience and are motivated by being a key player in Lean Six or Kaizen projects consider joining Kuehne Nagel.

Your Role

The Area Healthcare Quality Manager is responsible and accountable for the development and maintenance of the regional contract logistics (CL) Healthcare (PHC) quality management system (QMS) including the supervisory development, maintenance, and compliance of the local QMS (Quality Management Systems) at the individual healthcare warehouses according to any applicable local and international regulations, customer quality requirements, and internal Kuehne Nagel (KN) quality requirements. You will be responsible to ensure that each healthcare warehouse operates in accordance with the global commitment to excellence related to quality.

Your Responsibilities

• Develop and maintain the contract logistics pharma & healthcare (PHC) quality management system, regarding GMP (Good Manufacturing Practices)
• Ensure compliance of individual QMS ( Quality Management Systems) at the different local warehouse location according to all applicable regulatory, customer and company guidelines
• Functional and disciplinary leadership of all Local Pharma & Healthcare Operations Quality Managers at the individual local sites
• Support locations in dealing with customers, regulatory authorities, and suppliers on PHC quality related matters
• Be the regional PHC subject matter expert for any quality related matters in CL for the respective locations
• Be the regional counterpart for the national PHC CL quality manager and support the development, implementation, and enhancement of PHC quality measures within the network
• Provide consultancies for all PHC related quality management topics in contract logistics through the different steps of a project lifecycle (sales, RFQ support, implementation, operations)
• Perform pharma quality training (GXP, CAPA, change control, deviation management as required)
• Support the National Pharma Quality Manager to develop Pharma and Healthcare Quality guidelines, procedures and training as needed
• Implement and maintain a Regional Pharma & Healthcare Quality Management Systems within Contract Logistics
• business unit, in line and in compliance with Local, International as well as any KN Global applicable Guideline
• Provide Pharma & Healthcare quality expertise and leadership to management, operational personnel, and clients
• Support locations to Interact both internally with company personnel and externally with clients/ regulatory bodies
• Actively assure operational observance to compliance obligations to include, regulatory, contractual, and SOP driven requirements
• Actively look for ways to improve quality processes and procedures. Develop plans to evaluate Cost-of-Quality improvement projects. Continually seek to identify opportunities to reduce customer costs
• Create and implement Quality Inspection plans, manage quality process audits ensuring that self-inspections are performed at appropriate regular intervals and that areas for improvement are identified and addressed
• Make sure process metrics are established, and in-line and end-of-line process controls to ensure quality objectives are met
• Develop and Implement training programs, as required, to ensure quality objectives are met and to continually improve results
• Develop and maintain interactions with client Quality counterparts; actively understand and manage client Quality expectations
• Proactively communicate with client QA counterparts and management concerning quality issues, improvement plans, and status
• Support and make sure all Healthcare locations Investigate deviations and quality issues performing thorough Root Cause analysis and applying PDCA principles to the CAPA process.
• Assure team members have and actively follow processes for review and disposition of non-conforming product including management of product damage, expiry, quarantine, holds, returned goods, and recalls, ensuring that all relevant data is documented and communicated to clients
• Inform and prepare operational personnel regarding regulatory inspection readiness and act as the POC (person of contact) during inspections
  
  

Your Skills And Experiences

• A Bachelor's degree in Logistics, Biology, Business Management, or equivalent combination of education and work experience
• Minimum 5 years professional experience in the pharma & healthcare sector, preferably in the 3PL / logistics segment
• 5-10 years in a Warehousing environment
• Prior experience working in healthcare/medical device regulated environment required experience as quality manager, quality auditor or quality professional in the pharma and healthcare industry
• Demonstrated knowledge in ISO 13485 and ISO 9001
• Ability to travel an average of 25% of the time as needed
  
  

Good Reasons to Join

There has never been a better time to work in logistics. Bring your skills to an industry that offers stability and international career growth. We offer a great compensation and medical/dental benefits package, employee discounts, tuition reimbursement, excellent training programs, and a fun, and interesting global work environment.



Kuehne Nagel is committed to Equal Employment Opportunity (“EEO”) and to compliance with all federal, state, and local laws that prohibit workplace discrimination and unlawful retaliation. Kuehne Nagel strictly prohibits all discrimination on the basis of race, ancestry, color, age, national origin, ethnicity, religious creed or belief, physical or mental disability, marital or familial status, legally protected medical condition, genetic information, military or veteran status, sex (including pregnancy, childbirth, breastfeeding, or related medical condition), gender (including gender identity and gender expression), sexual orientation, citizenship status, protected activity (such as opposition to or reporting of prohibited discrimination or harassment. Kuehne Nagel will also make reasonable accommodations for disabled applicants and employees, including accommodations for pregnancy and childbirth, and for the sincerely held religious beliefs of applicants and employees depending upon individual circumstances unless such accommodation would create an undue hardship on Kuehne Nagel.