Job Summary
The Senior Manager of Manufacturing systems will drive technology solutions for digitization at the manufacturing shop-floor level. She must be familiar with ISA-95 standards and activities ranging from plant scheduling and operations to manufacturing operations management, and monitoring, supervisory control, and automated control of the production process, including Manufacturing Control Systems (PLC/HMI), Digital Factory/Manufacturing Execution Systems, and Enterprise Track and Trace/Serialization Systems.
Core activities include collaborating with business partners to understand their current and future state strategy, needs and requirements from a global perspective; to identify and prioritize areas for opportunity; gather and refine requirements, determine options for solution design, deliver enhancements, support integrations, and contribute to technology-driven projects and initiatives.
Once solution delivery projects are underway, manage the governance, provide project oversight, and drive the schedule to ensure adherence to the documented requirements of assigned IT Systems. This includes the full system lifecycle management process (system development, system maintenance & operation, compliance with regulatory requirements, incident & change management & retirement of systems). Ensure processes are in place for system maintenance & operation according to relevant regulatory authorities (GxP, Financial, Data Protection, etc.).
This includes the full systems life cycle management including system development, system maintenance & operation, compliance to regulatory requirements, incident & change management & retirement of systems
Essential Functions
New systems selection and implementation:
Interface with Manufacturing, Supply Chain/Warehousing, Facilities, Validation, Engineering, QA and QC to collect and document user stories / requirements for future state manufacturing processes
Assist in business process and system design; Proactively offer solution ideas and potential business process improvements in pursuit of driving efficiencies and meeting business needs
Develop and document functional and technical aspects of integrations between the Production scheduling, MES, Manufacturing Control System (SCADA), and electronic batch record platforms
Help create testing and validation plans; Ensure appropriate testing (i.e., Factory Acceptance Testing, Site Acceptance Testing, User Acceptance Testing, IQ, OQ, PQ, &/or Good Engineering Practice) is in place to ensure IT requirements are met.
Work closely with Compliance, Internal Audit and Quality Assurance groups as needed to ensure compliance with GxP regulations
Work with Enterprise Resource Planning solutions teams to define improvements and implement enhancements.
Maintain and support existing manufacturing IT systems:
Oversee & control the life cycle of production/manufacturing IT systems, as assigned
Partner with offshore team members and IT peers for platform and database support
Prepare & drive support agreements/SLAs with vendors & internal customers
Maintain system documentation for GxP critical IT systems
Responsible for change control & configuration management of systems
Ensure user training & user support is in place
Ensure data integrity & business/system continuity planning
Lead incident & problem investigations using Lean methodology & ensure quality deviations are remediated with appropriate effective corrective actions to ensure non-recurrence
Ensure system compliance with relevant internal SOPs & guidelines as well as external requirements (21CFR Part 11, Annex 11, Health Insurance Portability and Accountability Act (HIPAA), and SOX)
Represent IT systems in connection with audits & inspections. May lead cross-functional project teams for process improvement
Ensure continued & improved overall user satisfaction with systems
Monitor serialization and Track and Trace regulatory requirements and ensure Amneal is compliant
Manage all data flow across different environments for serialization data, including GS1 standards for serialization
Enable seamless operation of Track and Trace serialization systems:
Collaborate with external Supply Chain partners (CMO's, 3PLs, Wholesalers, Distributors, Customers) for real time visibility to support serialization activities
Assist in technical problem solving to resolve technical and compliance issues and propose process improvements to streamline operations
Provide support for packaging and labeling product security initiatives globally. Collaborate on qualification protocols for appropriate test design and execution
Monitor serialization and track and trace regulatory requirements and ensure Amneals compliance
Monitor and provide technical support for L4/L5 Serialization systems (rfxcel)
Collaborate with Supply Chain team to enable new partner and product set up in ERP/MDM/Serialization system
Investigate and verify negative responses to salable return verification requests
Education
Bachelors Degree (BA/BS) inIT/ Supply Chain/ Engineering or equivalent combination of experience & education -Required
Master Degree (MS/MA) inRelated field -Preferred
Work Experience
10 years or moreExperience with systems integrations to LIMS, CMMS, DMS, QMS platforms -Required
10 years or moreKnowledge in approaches and trends to enable Industry 4.0, lean manufacturing, digital manufacturing, etc -Required
Minimum of five (5) years of pharmaceutical industry experience (GxP) -Required
Minimum of five (5) years of supporting & troubleshooting automation/IT systems & batch processes -Required
10 years or moreKnowledge of pharmaceutical and/or biotech manufacturing processes -Required
10 years or moreFunctional knowledge of API processes & batch sequencing -Required
10 years or moreExperience in regulatory audits & inspections -Required
10 years or moreExperience of supply chain processes -Required
10 years or moreExpert in GxP documentation practices -Required
Skills and Abilities
Expert in system development & lifecycle management including validation of computer systems, operation & maintenance & retirement
Familiarity with incident management, contract/SLA Management, data integrity/retention/archive, continuity/recovery plans
Experience working with managed services and/or offshore teams
Proficient at troubleshooting (systematic problem solving) automated/IT system issues, including interfaces & hardware components
Understanding of IT frameworks such as COBIT, ITIL, GAMP, 21CFR Part 11, &/or PIC/S Annex 11
Experience in project teams driving deliverables, tasks, & activities for computer system validation
Experience in computer system validation, execution of testing, resolving of defects in a GxP environment
Experience with ERP integrations and shop floor equipment integrations; in particular from production routings to material management
Experience with analytical tools and platforms to document and analyze business process flows, business requirements, functional requirements
Highest personal and professional integrity and strong work ethics
Ability to articulate vision of transformation efforts and a sense of mission
Willingness to take change and provide direction
Results orientation, willingness to commit to a direction and drive operations to completion
Demonstrated ability to manage adversity and challenging situations
Communication, collaboration, and problem solving
Strong communication, interpersonal and collaborative skills
Ability to manage senior relationships across all the Business and Functional areas
Experienced and self-directed individual able to work independently and collaboratively in matrixed team environment
Ability to lead business users / stakeholders to complete assigned workstream tasks in a timely manner and with expected level of quality
Ability to handle complaints, settle disputes and resolve conflicts and negotiate with others
Collaborative team player orientation towards work relationships, strong culture awareness
Solid analytical and problem-solving abilities
Able to work in an open office environment with the possibility of frequent distraction
Able to work the hours necessary to support a 24/7 continuous manufacturing operation
Project Oversight and Decision-ing
Highly developed skills in priority setting and alignment of project priorities with Departmental strategy
Ability to break down complex problems and projects into manageable goals
Ability to get to the heart of the problem and make sound and timely decisions to resolve problems
Specialized Knowledge
2 years or more in Track and Trace/Serialization
5 years or more in IT, Manufacturing and Supply chain background
3+ years experience and in-depth knowledge of cGMP requirements of the Global Supply Chain Security program, including Serialization, Track-and-Trace, e-pedigree, Anti-counterfeiting technology, and Product Authentication
Ability to read/write EPCIS(XML) files and understanding of GS1 standards
Good understanding of database application such as MSSQL, MYSQL, Oracle and should have worked and provided technical input on Packaging line systems such as Systech, ACG and Optel.
In-depth knowledge of the Drug Supply Chain Security Act (DSCSA)
