RICHARD S. BRINSMADE, JR.
Bristol, CT 06010
Cell 203-***-****
Email: ad4qel@r.postjobfree.com
Professional
Objective: SENIOR QUALITY POSITION IN QUALITY ASSURANCE DISCIPLINE
EMPLOYMENT HISTORY
5/9/22 to ALLERQUEST, LLC.
Present PLAINVILLE, CT
POSITION: COMPLIANCE LEAD
Plan and Lead Supplier Quality Program
oDevelop annual audit schedule
oComplete supplier audits according to plan
oComplete supplier risk assessment
oComplete supplier performance monitoring
Developed supplier scorecard
oInitiate, review and approve Quality Technical Agreements with key suppliers
oReview and assess supplier change notifications
Initiate internal change requests if required
Plan and Lead Internal Audit Program
oDevelop annual internal audit schedule
oPerform internal audits and report findings, track corrective actions for Quality System elements
oTrain associates to conduct internal audits
Plan and Lead Management Review Program
oCoordinate compilation of Management Review data
oDevelop supplier data and internal audit data for inclusion in Management Review
oLead presentation to Company President and AllerQuest Management staff
General Compliance Support (as needed basis)
oReview Corrective and Preventative Actions specifically for impact on vendors as well as for overall compliance with internal policies
oReview of protocols and reports
10/05 to JANSSEN SUPPLY CHAIN (JSC)
8/17 HORSHAM, PA
(Retired)
POSITION: MANAGER, EXTERNAL SUPPLY INTEGRATION QUALITY (ESIQ-NA)
Plan and Lead Supplier Audits for API, Excipient, Packaging, Device, and Sterilization suppliers
oInternational and domestic travel approximately 50-60% of time.
oPlan and conduct audits of Suppliers of Medical Devices and Device Components
oAuthored audit agendae and audit reports
oLead SQ activities related to new Combination Products or Devices
oDevice SME for ESIQ- SQ related to Device and Device Component suppliers and manufacturers.
oProvide SQ representation on new product development for combination products.
Direct and Manage the Development, Partnership, and Deployment of 3rd Party Auditing Service for JSC.
Led the initiation of deployment of the innovative process of SQE2 within JSC.
ESIQ Supplier Account Owner for suppliers of excipients, medical devices, packaging components, external manufacturers, and other component suppliers worldwide
Account Owner for the Vacaville (ALZA) facility.
oDeveloped Quality KPIs, and presented results at Management Reviews
Leads SQ activities on new products related to combination products in areas of stem cell development, and other drug/device and bio/device combination products.
Direct Supplier Quality activities related to External Manufacturers product quality issues, specifically in the areas of Combination Products.
Received several Johnson & Johnson awards for key participation in audits, and collaboration between sectors (Pharma/Consumer/Medical Devices).
2/05 to ETHICON, INC.
10/05 SOMERVILLE, NJ
POSITION: SENIOR PROJECT MANAGER- COMPLIANCE
Plan and conduct audits of chemical, component, and external manufacturing suppliers worldwide. Author audit agendae and audit reports
Support plant QA as required
Initiated trials and primary site user of Pilgrim supplier audit database
8/03 to MEDEX, INC. (acquired from Ethicon Endo-Surgery)
2/05 SOUTHINGTON, CT
POSITION: CORPORATE COMPLIANCE MANAGER
Conducted internal audits of all Medex facilities worldwide
Conducted critical supplier audits for all Medex facilities
Authored all audit agendae and audit reports
Developed corporate internal audit and supplier audit procedures for use at all North America facilities
Served as Interim Quality System Manager for the Monterrey MX facility from 9/03 to 9/04
Led various integration teams following acquisition by Medex
Led team for FDA facility inspections of Monterrey Mexico and Southington plants resulting in zero 483 items and zero recommendations
Led audit teams for Southington and Monterrey sites ISO audits resulting in zero nonconformances
11/97 to ETHICON ENDO-SURGERY
7/03 SOUTHINGTON, CT
POSITION: MANAGER, COMPLIANCE and SUPPLIER QUALITY
Developed, prepared, and presented facility quality metrics for Management Review
Lead Quality Starpoint Team (Quality Council)
Established and managed multi-site CAPA system
Authored applicable procedures and Work Instructions
Provided on-site QA/Compliance support for Monterrey, MX facility (35-50% of time spent in Monterrey MX)
Authored SOPs, Work Instructions, and Process Controls for key Quality System elements
Provided Compliance training and coaching for CT and Monterrey sites
Managed supplier and internal audit programs
Managed facility Management Action Plan to assure regulatory compliance. Prepared metrics and reported in Management Review
Managed environmental monitoring, complaints, raw material inspection, and sterilization issues for facility in order to meet and exceed regulatory requirements
Reviewed SOPs, Work Instructions, Inspection Methods, Process Controls and revised as required
Lead multiple acquisition transition teams, including Supplier Quality, Sterilization, and Compliance. Conducted gap analysis of related procedures, and revised procedures as required
Lead multiple facilities in ISO/EN/CMDCAS assessments
Successfully managed assessment to enhance ISO certification to include Design Control. Authored Design Control SOPs and Work Instructions
Led benchmarking of Management Review, CAPA, and Compliance Reporting with multiple companies
Initiated future state compliance assessments for CT and Monterrey sites
Negotiated pricing for outside laboratory tests resulting in annual cost savings of $150k
50-75% travel
PREVIOUS
POSITION: MANAGER, SUPPLIER/PRODUCT QUALITY
Managed raw material inspection, calibration, metrology, in-process quality, and post-sterile inspection
Member of Signature of Quality Supplier Management Team, developed multi-site Supplier Quality Process
Implemented FMEAs and Corrective Actions with key suppliers resulting in 80% reduction of non-conformances
Completed Johnson and Johnson Leadership Development
Completed Black Belt (Six Sigma) Training and Supplier Certification Project
Authored Supplier Certification SOP
Managed 10 direct reports
6/93 to JOHNSON & JOHNSON PROFESSIONAL, INC.
11/97 STAMFORD, CT (formerly Joint Medical Products)
POSITION: MANAGER, QUALITY SYSTEMS
Managed all QA/QC functions for Stamford facility
Managed facility GMP program to assure compliance with FDA and ISO requirements
Managed sterilization validation programs
Authored Process and Product Validation Protocols (IQ, OQ, PQ) and Validation Summary Reports
Developed and implemented supplier and operator certification programs resulting in indirect labor cost reductions
Responsible for daily regulatory compliance of facility
JJPI Award of Excellence for directing facility ISO certification efforts
Developed, maintained, and monitored department budget
Managed 8 direct reports, 21 total reports
PREVIOUS DIRECTOR OF QA/RA (with Joint Medical Products)
POSITIONS: MANAGER OF QUALITY ASSURANCE
Managed all QA/QC/Regulatory compliance activities
Managed supplier audit program to assure quality of incoming components. Authored audit agendae and audit reports
Managed complaint reporting process in accordance with FDA requirements
Reviewed 510(k)s prior to FDA submission
12/83 to DAVIS & GECK, DANBURY, CT
5/93 POSITION: MANAGER- GMP & VALIDATION
Validated sterilization and manufacturing processes. Authored Validation protocols and summary reports
Audited facility and suppliers to assure GMP compliance
Developed and maintained GMP training program
Managed plant document systems (SOP/DMR/ MCN)
Coordinated plant customer dissatisfaction program
PREVIOUS
POSITION: PRODUCTION MANAGER
Managed seven departments, including incentive-paid and wage employees, and a custom order department
Directed 6 supervisors, 1 manufacturing engineer, 1 quality
engineer, with overall responsibility for 140 employees
Had total accountability for departments’ quality,
productivity, and financial performance
Developed and monitored budget of $16MM
Completed variance analysis as required
PRIOR
POSITIONS: MANUFACTURING ENGINEER
PRODUCTION SUPERVISOR
3/79 to MK LABORATORIES, INC., FAIRFIELD, CT
12/83 POSITION: PRODUCTION SUPERVISOR
Supervised 40 hourly employees in pharmaceutical
manufacturing plant
Supervised packaging of solid and liquid dosage forms
Supervised tablet manufacturing and capsule filling operations
12/76 to ANALABS, INC., NORTH HAVEN, CT
3/79 POSITION: CHEMIST
Synthesis of analytical chemical standards
Synthesis of stationary phases for gas chromatographs
Promoted several times to chemist position
EDUCATION
B.S. Biology, Sacred Heart University
Post-grad studies Health Care Policy and Management
Various training courses including Software Validation, Supplier Auditing
ASQ CQA (Certified Quality Auditor- cert. 27443)
ASQ CQM (Certified Quality Manager- cert. 7995)
ASQ Senior Member
SOFTWARE
MS Office Suite (Word, Excel, Powerpoint)
Trackwise
ComplianceWire
Pilgrim
MS Project (limited)
Minitab