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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 Senior Quality Manager leads and provides strategic direction for the quality assurance / control efforts all Cencora 3PL distribution centers. The Senior 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.
Experience & Education:
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.
Skills & Knowledge:
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
We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora
Full time
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Affiliated Companies: Integrated Commercialization, LLC
