Kacy Miller Email and Phone Number
Global Quality Lead, Operations at Janssen Pharmaceuticals at
@
The Janssen Pharmaceutical Companies of Johnson & Johnson
Kacy Miller's Location
Somerville, New Jersey, United States, United States
Kacy Miller's Contact Details
Kacy Miller work email
- Valid
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Kacy Miller personal email
n/a
About Kacy Miller
20+ years experienced professional with a demonstrated history of working in the medical device industry and pharmaceutical industry. Extensive background in operations, engineering and quality. Skilled in Medical Devices, Combination Products, Pharmaceuticals, People Management, Continuous Improvement, ISO Standards, and U.S. Food and Drug Administration (FDA).
Kacy Miller's Current Company Details
The Janssen Pharmaceutical Companies Of Johnson & Johnson
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Global Quality Lead, Operations at Janssen Pharmaceuticals
Kacy Miller Work Experience Details
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Global Quality Lead, OperationsThe Janssen Pharmaceutical Companies Of Johnson & Johnson Mar 2022 - PresentRaritan, New Jersey, UsResponsible to assure that new modality products (vaccines, CAR-T) global releases, schedule and quality contractual agreements and requests are communicated to key stakeholders in Quality as well as global operational teams and assuring that all necessary activity management are in place. Responsible for submitting necessary batch release information from vaccines batches to government and other authorities. Responsible for the New Modalities PMO cross functional team directing the activities for global releases of the products, assuring that improvement activities across the production processes are established and final assurance that cross coordination of releases and delivery schedule.Management of a team responsible for Global Quality System Management Review, Global Insight Management, Business Performance Metrics, and Risk review.
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Board PresidentNazareth Soccer Club Nov 2021 - Nov 2023Nazareth, Pennsylvania, UsBoard President for Nazareth Soccer Club -
CoachNazareth Soccer Club Aug 2016 - Jun 2023Nazareth, Pennsylvania, UsI coach soccer for the Micro program (U-4 through U-8) and Classic program (U-9+).
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Senior Engineering ManagerEthicon, Inc. Apr 2016 - Mar 2022Raritan, Nj, UsManaging a staff of engineering professionals within the Wound Closure Product Management Engineering group and also serve as part of the technical staff within the group to assist in the process development for new and existing products. Responsible for:- Development of associates through objectives setting, performance reviews, and development planning. - Creating a compelling work environment in which every associate is valued and recognized for their contribution to our success. - Ensuring the group conforms to applicable Ethicon Quality System procedures and associates are properly trained on procedures and keep current to technology. - Consistency in the approach and methodologies across the group - SME in Process Characterization & Development - SME in combination products (device/drug) as well as manual cleaning validation. I am serving as a process development lead for new products projects, providing technical input to plan, design, development, and validation activities of the manufacturing processes and equipment. I review process development, validation protocols and strategies. I am accountable for appropriate development and execution of process development and validation activities at external suppliers.I am passionate about promoting diversity and inclusion in the organization. I am leading the diversity & inclusion team at the local Ethicon campus and I am also the co-chair of the Women’s Leadership & Inclusion employee resource group. I also am passionate about giving back to the community. I currently lead the Operation Smile campaign for the North America Ethicon sites and co-lead United Way campaigning on the local campus. -
Engineering ManagerEthicon, Inc. Sep 2014 - Apr 2016Raritan, Nj, Us
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Lifecycle ManagerEthicon, Inc. Mar 2013 - Sep 2014Raritan, Nj, UsAccountable for lifecycle project portfolio management including quality, product performance, line extensions, delivery and cost initiatives. Identified & lead projects to improve Ethicon's product offering as required by business objectives of assigned product platforms. Reviewed and approved potential process changes for their effect on product performance. Lead resolution of significant product issues. Key responsibilities include:Driving strategies and initiatives to proactively improve product quality, performance and cost. Lead the Lifecycle Project Portfolio Review Process which includes a cadence of obtaining project requests and leading cross-functional team to review the projects' business case, conduct risk analysis and develop recommendations for approval, priority and project change governance/test requirements. Represented Lifecycle Portfolio recommendations to appropriate governance bodies for approval of recommendations. Lead projects to drive improvements in product supply or performance, or to respond to unplanned event. Maintained product design and process knowledge for those platforms I was responsible for. Lead and conducted proactive risk analysis and mitigation strategies for continuity of quality supply.
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External Operations Staff EngineerEthicon, Inc. Nov 2010 - Mar 2013Raritan, Nj, Us- Responsible for ensuring quality and supply continuity of purchased finished goods; completing failure investigations for customer complaints; completing failure investigations for CAPA's and NCR's; completing validations to replace materials or components with limited supply; initiating and leading cost improvement projects; and accelerating growth through introduction of new products coming into the External Operations portfolio. - Leads cross functional teams to address quality, supply continuity, and cost management challenges. Ensure the team has what they need in terms of resources, tools, and information to make decisions. Effectively defines and manages requirements/ boundaries for intellectual property or trade secrets when working with external partners. - Maintains clear communication with internal and external business partners regarding expectations, satisfaction, or quality of results.
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Team LeaderOrtho Clinical Diagnostics Oct 2008 - Jan 2011Raritan, Nj, Us•Responsible for managing and staffing 40-50 operators and 4 production lines in a Continuous Operations environment (24/7)•Transitioned department from running 24/5 to 24/7, requiring staff shift change from 8 to 12 hours•Manage both international and domestic product lines - Implemented a new manufacturing line to expand production capacity - Implemented a new manufacturing line to expand production capacity and provide business continuity •Conduct root cause investigations and respond to customer complaints•Partner with materials management to ensure healthy inventory levels of both raw materials and finished goods•Initiate nonconformances and implement corrective actions•Respond to and interact with regulatory agencies •Responsible for performance and development plans of operators (Operator 1 through Operator 4) and co-ops/interns•Maintain department budget•Partner with maintenance to restructure the preventative maintenance schedule for continuous operations transition•Enforce compliance in following SOP’s and GMP’s in an FDA regulated environment -
Operations EngineerOrtho Clinical Diagnostics Jun 2003 - Sep 2008Raritan, Nj, UsProject Manager for a site technology transfer from Pompano Beach, Fl to Raritan, NJProject Leader for capital project implementation. Required to maintain capital budget and project timeline, work in cross-functional teams to align department goals, generate validation protocols, and report progress to management.Lead cross functional teams in root cause failure investigationsDevelop Design of Experiments (DOE) for process improvements and cost saving initiativesExecute Validations of Manufacturing Processes and Equipment Perform scale-up validation studies for new product launchesSubject Matter Expert in Process Mixing, Vial Washing, and Statistical Sampling
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RecruiterJohnson & Johnson 2003 - 2009New Brunswick, Nj, UsResponsible for co-op/intern recruiting for Ortho Clinical Diagnostics - Raritan Operations. -
Process Excellence Engineer Co-OpOrtho-Clinical Diagnostics Dec 2001 - Aug 2002Manipulated cycle time data to research the optimization of the production of Donor Screening kitsAssisted in the development of the Special Recognition Program, which recognizes employees in the area of operationsCompiled and interpreted data for a monthly productivity reviewDeveloped a system to track the daily production schedule of each department in Donor Screening
Kacy Miller Skills
Cross Functional Team Leadership
Capa
Fda
Manufacturing
Quality System
Validation
Medical Devices
Process Improvement
Six Sigma
Iso 13485
Quality Assurance
Lean Manufacturing
Gmp
Technology Transfer
Design Of Experiments
Product Development
Leadership
Management
Continuous Improvement
V&v
R&d
Supply Chain
Iso
Materials Management
Quality Auditing
Kacy Miller Education Details
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Penn State UniversityChemical Engineering -
Lehigh UniversitySupply Chain
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East Stroudsburg University Of PennsylvaniaChemistry
Frequently Asked Questions about Kacy Miller
What company does Kacy Miller work for?
Kacy Miller works for The Janssen Pharmaceutical Companies Of Johnson & Johnson
What is Kacy Miller's role at the current company?
Kacy Miller's current role is Global Quality Lead, Operations at Janssen Pharmaceuticals.
What is Kacy Miller's email address?
Kacy Miller's email address is kk****@****jnj.com
What schools did Kacy Miller attend?
Kacy Miller attended Penn State University, Lehigh University, East Stroudsburg University Of Pennsylvania.
What skills is Kacy Miller known for?
Kacy Miller has skills like Cross Functional Team Leadership, Capa, Fda, Manufacturing, Quality System, Validation, Medical Devices, Process Improvement, Six Sigma, Iso 13485, Quality Assurance, Lean Manufacturing.
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