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

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