Mgr Quality Assurance

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 Med Tech, 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.

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As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Athens, Georgia, United States of America, Gurabo, Puerto Rico, United States of America, Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America

Job Description:

Position Summary

Innovative Medicine Transcend is a global business transformation program that will modernize our foundational transactional processes and harmonize them into one "clean" ERP as a standardized platform for growth and efficiency gains.

The program will simplify the Innovative Medicine ERP landscape from 7 to 1, standardizing processes in order to have a cost effective, fit for purpose digital backbone that will enable us to support the Innovative Medicine business with agility. Additionally, the program will remediate the end-of-life system exposure that we risk towards the end of this decade.

Other J&J Innovative Medicine manufacturing / principal locations may be considered for the ideal candidate.

Major Duties & Responsibilities Pillar Specific

Approximate Percentage of Time

Tasks/Duties/Responsibilities

20% :
Provide guidance to the MAKE Quality Management (QM) workstream Team through program design & build, execution as well as deployment phase, while ensuring Business Process standardization

10% :
Assist in the development of program materials i.e. Business Process Flow Diagrams (BPMs), Key Decision Documents (KDDs), Business User Stories (BUS), Taxonomy Levels as well as persona definition as part of the User Access Management

25% :
Perform test & release activities including Business Simulation Testing (BST), System User Acceptance Testing (UAT), Security Role Testing, Integration Testing etc.

15% :
Develop in collaboration with Business Adoption the necessary training material and deliver the training

15% :
Develop applicable SOPs, WI's and/or User Manuals

10% :
Support the preparation and execution of system cutover, data migration, data conversion, system deployment and hypercare

5% :
Act as backup for the MAKE Global Business Template Owner Quality Management as required

Other Duties

• Support the MAKE Global Business Template Owner for all program activities and act as part of the pool of MAKE Global Business Template Managers & Analysts to support all program activities

• Support definition of key decisions related to process improvements to meet all compliance and regulatory requirements.

• Act as a leader to nurture a culture which monitors and meets the needs of the business through process excellence and improvement

• Communicate effectively as a spokesperson for the QM processes

• Build and maintain relationships at all levels throughout the organization

Required Qualifications

• Experience in Supply Chain (Plan, Source, Make, Deliver, Finance and/or Master Data as well as Data and Analytics) is required

• Practical experience with ERP SAP Quality Management (QM) in J&J IM is a requirement

• Experience in Business Processes related to ERP SAP Quality Management (i.e. Quality Inspection, Batch Release, Supplier Qualification, Process Validations etc.)

• ERP SAP (ECC6 and/or S/4
  
  HANA) knowledge and practical application is required

• Experience with Comet, eLIMS or Manufacturing Execution System (MES) is an advantage

• Strong English verbal and written communication skills, including presentation skills is required

Preferred Knowledge,

Skills and Abilities

:

• Understanding the business process linkages in Supply Chain across Plan, Source, Make, Deliver, Finance, Master Data is required

• Practical experience in a pharmaceutical manufacturing/packaging environment is necessary

• Experience in Business Processes related to ERP SAP (ECC6 and/or S/4
  
  HANA) knowledge and practical application is required

• Background in External / (Third Party / Contract Manufacturing) Quality, Market Quality, and/or Commercial Quality is an asset

• Experience in Master Data, Advanced Planning, Product Labelling, Materials Management, Serialization, Track & Trace or Process Order Management is an advantage

• Experience working in a regional/global setting, or experience in a large-scale business transformation project…