Quality Manager - District Services

Quality Manager

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This role is in support of Cencora's third party logistics service in the US operating through our ICS business. Under minimal supervision of the Senior Director of Quality & Regulatory Affairs, the Quality Manager leads and provides strategic direction for the quality assurance / control efforts all Cencora 3PL distribution centers. The Quality Manager has responsibility for planning and implementing actions to ensure compliance with appropriate quality, regulatory and validation guidelines. This position is categorized as compliance critical and, as such, requires and is assigned specific responsibility for ensuring continual and proper compliance with all division, corporate and regulatory requirements.

Leads and provides strategic direction of the Quality Assurance / Control efforts at ICS Louisville Distribution Centers (DCs) activities.

Responsible for planning and implementing actions to ensure compliance with ISO9001:2015 cGMP registration and regulatory / validation compliance for all ICS DCs.

Develops and champions continuous improvement across all ICS DCs.

Trains and manages quality staff to implement and maintain quality initiatives and continuous improvement initiatives related to distribution services.

Provides guidance to Operations unit in matters related to quality.

Maintains working relationships with regulatory and client / customer quality organizations.

Develops and maintains effective audit programs for all ICS DCs.

Oversees client audits of DCs and appropriate corrective action efforts and quality indicators and root cause analysis.

Responsible for the maintenance, execution, and monitoring of the BU Location's Quality Management System (QMS), Good Distribution Practices (GDP), and compliance with all local state (BOP, DOH, etc.),, and federal regulations (DEA, EPA, FDA, OSHA, etc.) as well as all corporate policies and procedures.

Monitors, verifies, and maintains all BU location local, state, and federal licensure and registrations as required.

Acts as primary liaison between BU location and all local, state, and federal regulatory agencies. Manages and/or assists with all inspections, investigations, and information requests.

Conducts required Quality, Health & Safety, Security and Regulatory Assessments.

Reviews and approves documents that govern activities in the DC and QMS. The SQM confirms the content of the document is complete, comprehensive, and accurate. The SQM is the last quality review before a document is published for use by employees and external auditors.

Communicates the performance data of the facilities to the QA Lead Team.

Provides data about the facilities successes and opportunities for the bi-annual management review.

Manages the process audit program in the DCs.

Provides inputs and attends quality hosted meetings of monthly CI Steering Committee, Bi-Annual Management

Reviews, and weekly NC/CI meeting.

Requires broad training in fields such as business administration, accountancy, sales, marketing, computer sciences or similar vocations generally obtained through completion of a four year bachelor's degree program.

Normally requires a minimum of eight (8) years directly related and progressively responsible experience, including at least four (4) years at a manager level.

Completion of the American Society for Quality (ASQ) Certified Quality Manager (CQMgr), Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) programs; multiple certifications highly preferred.

Detailed understanding of warehouse operations and automated warehouse operating systems

Thorough knowledge of regulatory compliance matters

Ability to communicate effectively both orally and in writing

Effective presentation skills

Ability to train, motivate and direct the work of others

Ability to plan and conduct effective meetings

Strong analytical and mathematical skills

Strong interpersonal and leadership skills

Strong organizational skills; attention to detail

Ability to meet deadlines and work in a production-driven environment

Strong decision making skills

Excellent problem solving skills; ability to resolve issues effectively and efficiently