Tim Cagle Email & Phone Number
@its.jnj.com
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Who is Tim Cagle? Overview
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Tim Cagle is listed as MATERIAL QUALITY LEAD - SUPPLIER QUALITY at Kenvue, a company with 17968 employees, based in Greater Philadelphia, United States, United States. AeroLeads shows a work email signal at its.jnj.com and a matched LinkedIn profile for Tim Cagle.
Tim Cagle previously worked as Material Quality Manager - Supplier Quality at Kenvue and Consent Decree - Senior Quality Consultant at Johnson & Johnson - Mcneil Consumer Healthcare. Tim Cagle holds Aos, Massage Therapy from Swedish Institue College Of Health Sciences.
Email format at Kenvue
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AeroLeads found 1 current-domain work email signal for Tim Cagle. Compare company email patterns before reaching out.
About Tim Cagle
Result driven, action-oriented, Quality professional who values effective and efficient compliance solutions. Over two decades of experience with increasing levels of responsibility. Proven ability to lead and influence cross-functional teams based on understanding needs, clarifying roles and responsibilities, active listening, diplomacy and negotiation. Skills/Qualifications: • Cross-functional Team Leadership and Work Stream Coordination and Alignment• Quality System Gap Analysis, Risk Assessment, Remediation and Integration• Investigations, Non-Conformances, Deviations, Effective CAPA Management • Supplier and API Quality Management, Quality Agreements and Supplier Quality Audits • GMP/PAI Compliance Auditing, Corrective Action Negotiation, Follow-up and Closure• Pharmaceutical, OTC, Medical Device, Consumer Healthcare and Cosmetics• 21CFR11/210/211/820, ICH Guidelines, ISO 9001/13485
Listed skills include Gmp, Capa, Validation, Change Control, and 11 others.
Tim Cagle's current company
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Tim Cagle work experience
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Material Quality Manager - Supplier Quality
Current- Responsible for quality oversight of project related and supplier initiated change management for raw materials and packaging components for North America
- Responsible for Raw Material Center (RMC) and Packaging Material Center Quality Assurance representative
- QA approver for Global Change Controls (GCCs). Daily prioritization of change management activities to support concurrent manufacturing.
- Responsible for the quality oversight and approval of 300+ change controls concurrently
- QA Project representative for USP <661> compliance
- Lead team for development of Global Mold Management Program
Material Quality Lead - Supplier Quality
- Change Management Quality Manager for Supplier Quality Assurance (SQA) and Packaging Material Center (PMC).
- PMC Cross-functional team member (ie. Quality Assurance representative)
- QA approver for Global Change Controls and packaging component specifications to support daily operations at 40+ External Manufacturing sites and three Internal manufacturing locations.
- Revised Packaging Component Change Control Matrix to standardize deliverables
- Revised 19 packaging Critical Quality Requirements (CQR), which define defect categories and AQLs
- Negotiated 26 QRAs with key primary/secondary packaging component suppliers in five (5) months.
Consent Decree - Senior Quality Consultant
- Consent Decree Management Team
- Mentor remediation teams on Consent Decree Processes Management Controls, Change Control, Validation, Product Development, Technology Transfer, External Manufacturing, Contract Laboratories, Supplier Management, Audits.
- Assist with coordination and communication of CD Work Plan team interdependencies
- Drive remediation efforts to Base Business and escalate issues impacting success
- Communicate lessons learned across CD Work Plan teams and manufacturing sites
- Implement Audit Site Readiness program at Lancaster and Ft Washington EMQA
Consent Decree - Senior Quality Consultant
- Support McNeil External Manufacturing Quality Assurance (EMQA) during Consent Decree remediation activities
- Revised internal procedures for Batch Record Review and Approval, Reduced Batch Record Review Qualification, Comparison of McNeil BOM to Contractor Master Records, Creation Review and Approval of BOM, Control of.
- Lead Investigator for the timely completion of past due Contractor Investigation Reports (CIRs)
- Formed new APR group of eight (8) personnel to address extensive backlog of APRs
- Developed APR data mining processes for Product Returns, Recalls, Field Alerts and Change Controls
Compliance Manager
- Performed GMP/PAI compliance audits at 34 manufacturing facilities worldwide and Consent Decree Verification audits across four domestic (US and Puerto Rico) manufacturing facilities.
- Lead auditor for GMP and pre-PAI compliance audits in 15 different countries
- Experienced auditor for API, solid dose, liquids/ointments/creams, aerosol, biological and sterile manufacturing, warehousing and distribution facilities for both human and animal pharmaceutical products
Senior Quality Auditor
- Supplier Auditor supporting the new Supplier Audit Management program for all NA GSK facilities
- Developed a consolidated NA Approved Supplier List to support all domestic GSK manufacturing facilities.
- Supplier quality audits of direct/indirect suppliers (API, RM, PC, contract lab, GMP critical suppliers and TPMs)
- Supported the inspection control room for audits conducted by corporate, domestic and international RA’s
Compliance Specialist
- Ensure specifications comply with a global end-market regulatory requirements
- Revised product release specifications against relevant regulatory filings (IND, NDA, ANDA, DMF, MAA, EDMF)
- Generated raw material and final product specification for External Manufacturing facilities
- Performed site-wide internal GMP compliance audits to support the QA internal audit program
Qc Laboratory Release Manager
- Lab Manager for the analysis of raw materials, packaging materials, final products and USP water system
- Approved/Released analytical results for RM/PC to the manufacturing and packaging business units
- Reduced laboratory investigations 30% in one year
- Developed Quality Metrics/KPIs for Lab and internal alert/action limits for Manufacturing
- Tech Transfer team member for Nexium (Esomeprazole) from AstraZeneca
Analytical Chemist
- QO Chemist supporting solid dosage manufacturing
- HPLC analysis for final product/stability (i.e. Assay, Dissolution, Content Uniformity, Friability, and Appearance)
- Cleaning Validation Studies for manufacturing/packaging equipment (e.g. presses, blenders, fillers, cappers)
In-Process Chemist
- QC Technician promoted to Chemist supporting 3 API manufacturing facilities running 24/7/365
- Analysis by HPLC, CZE, GC, UV-Vis, FTIR, KF, Auto-Titrator, Microtrac, Polarimeter, Melting Point, ROI, etc…
- Troubleshoot and repair laboratory equipment (e.g. columns, UV lights, pH meters, balance checks, KF factors)
Tim Cagle education
Aos, Massage Therapy
Bs, Chemistry
Frequently asked questions about Tim Cagle
Quick answers generated from the profile data available on this page.
What company does Tim Cagle work for?
Tim Cagle works for Kenvue.
What is Tim Cagle's role at Kenvue?
Tim Cagle is listed as MATERIAL QUALITY LEAD - SUPPLIER QUALITY at Kenvue.
What is Tim Cagle's email address?
AeroLeads has found 1 work email signal at @its.jnj.com for Tim Cagle at Kenvue.
Where is Tim Cagle based?
Tim Cagle is based in Greater Philadelphia, United States, United States while working with Kenvue.
What companies has Tim Cagle worked for?
Tim Cagle has worked for Kenvue, Johnson & Johnson - Mcneil Consumer Healthcare, Schering-Plough Corporation, Glaxosmithkline, and Merck.
How can I contact Tim Cagle?
You can use AeroLeads to view verified contact signals for Tim Cagle at Kenvue, including work email, phone, and LinkedIn data when available.
What schools did Tim Cagle attend?
Tim Cagle holds Aos, Massage Therapy from Swedish Institue College Of Health Sciences.
What skills is Tim Cagle known for?
Tim Cagle is listed with skills including Gmp, Capa, Validation, Change Control, Quality System, Fda, Quality Assurance, and Quality Auditing.
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