Life Science Manager

R sum

JASON A. GILLETTE, CNPRx, CDR, DRIC

**** ***** ***** ***. ***. 203, Rock Hill, SC 29732

716-***-**** ***************@*****.***

http://www.linkedin.com/in/jasongillette94

EMPLOYMENT SYNOPSIS: Yrs.

Life Science Leadership Roles 15

Healthcare Supply-Chain - Regulatory Compliance/ 13

Quality Assurance

FDA Regulations - Parts 111, 210/ 211, 820, 13

cGMP, etc.

Medical Device & Pharmaceutical Manufacturing 9

Inventory Management - API's, Excipients, 9

Finished & Packaging

Quality Management System (QMS) - Designing/ 8

Authoring

Licensed and/ or Registered by State Board of 8

Pharmacies - CDR

Rx Drug, Device & Medical Product Wholesale 8

Distribution & Third-Party Logistics (3PL)

Solutions

Project Management 8

Regulatory Affairs 7

Sales & Business Development 2

REGULATORY EXPOSURE: HEALTHCARE/ ETHICS COMPLIANCE

ACUMEN:

. FDA (Food and Drug Administration) . AdvaMed Code

(Advanced Medical Tech. Association)

. 50 State Boards of Pharmacy; Radiological Health Divisions . PhRMA Code

(Pharma Research & Manufacturers)

. DQSA (Drug Quality and Security Act) . HIPAA (Health

Insurance Portability & Accountability)

. PDMA (Prescription Drug Marketing Act) . AMA (American

Medical Association)

. PDA (Prescription Drug Amendment) . OIG (Office of

Inspector General)

. NABP VAWD (Verified-Accredited Wholesale Distributors )

. DOH (Department of Health)

. DEA (Drug Enforcement Administration)

. OSHA (Occupational Safety & Health Administration)

. EPA (Environmental Protection Agency)

. DOT (Department of Transportation)

. USC (United States Code); FR (Federal Register)

. Dept. of Agriculture; DOL (Dept. of Labor)

. DoJ (Dept. of Justice)

. FDA Guidelines for State Licensing of Wholesale Rx Drug Distributors

. GLP (Good Laboratory Practices) & GCP (Good Clinical Practices)

. Public Health Security & Bioterrorism Preparedness & Response Act

(Bioterrorism Act)

LICENSES/ CERT.'s:

. CQE (Certified Quality Engineer) - Completion Date: June 2015

. CNPRx (Certified National Pharmaceutical Rep. - Cert #: 579162011);

NAPSRx

. ISO 13485:2003 Internal Auditor, Medical Device (ISO 9001: 2000) - RABQSA

Accredited

. CDR (Certified Designated Rep.); Florida DBPR

. DRIC (Drug Wholesaler Designated Rep. In-Charge); California Board of

Pharmacy

SPECIALIZED EDUCATION:

. REMeDI (Regulatory Environment of Medical Devices & Implants) - Graduate

Cert.

. Bio-Manufacturing Training - Cert.

. Becoming a Leader in the Life Sciences - Cert.

. CDRH Learn, FDA's Center for Devices & Radiological Health - Multiple

Cert's

. OSHA 511: Occupational Safety & Health Standards for General Industry -

Cert.

. Precision Machining - Diploma

EMPLOYMENT HISTORY:

Regional Quality Systems Manager; Fresenius Medical Care, Inc.; Rock Hill,

SC (02/2014 - 12/2014)

Directed/ maintained a compliant FDA/ State Board of Pharmacy Quality

System driven by Metric Trending Plans & Scorecards for 14 Distribution

Centers, 800+ indirect reports & dialysis drugs/ devices:

. Provided leadership for site development, deployment and

maintenance of strategic quality requirements

. Collaborated with business partners to mitigate compliance risks at

manufacturing sites (e.g., Damaged product)

. Proactively identified risk management & compliance leverage

opportunities (e.g., Supplier management)

. Interacted/ influenced regulatory authorities & industry organizations

in decision-making

. Developed/ maintained internal and external audit program (e.g.,

Supplier, Corp., VAWD, BOP)

. Formulated/ influenced policy changes; ensured changes are implemented

across all sites

. Oversaw complaint program harmoniously with manufacturing & regulatory

reporting requirements

. Implemented Drug Quality and Security Act (DQSA); product tracing &

Identification of Suspect Product/ Notification

Regulatory Compliance Coordinator; Int'l Pharma Packaging & Distribution;

Fort Mill, SC (03/2012 - 02/2014)

Oversaw contract repackaging/ relabeling compliance of solid oral dosage

forms (capsules, tablets, soft gels) & third-party logistic (3PL)

distribution; includes medical devices, Rx/ OTC drugs, medical foods, &

dietary supplements:

. Director of Quality Assurance Alternate . 50 State

license/ permit initiation & renewal oversight

. Facility Drug & Device Establishment . Qualified

Suppliers/ Co. via Bioterrorism Act;

protected public

Registration & Listing oversight

from threatened/ actual terrorist attack on U.S. food supply

. Created Business Plans for Rx Drug Samples .

Electronic Structured Product Labeling (SPL)

& Controlled Substance Distribution & Listing via

Electronic submissions Gateway (ESG) oversight

. Revamped Quality Agreements outlining sales, . Compliance

projects, timelines & budgets (i.e.,

ePedigree/ Rx

manufacturing & distribution practices Product Tracing)

management

. Quality System implementation/ change control . Health Canada's

Foreign Site GMP compliance

. Business development/ plans, Gap Analysis, per Natural Health

Products Regulation (NHPR)

Risk/ Benefit Analysis . Certificates of

Conformances/ Analysis processing

. Primary contact with Board of Pharmacies . Batch records &

Certificate of Assurance creation

. Orchestrated quality audits via SOP's . Corrective & Preventative

Actions (CAPA) control

& Supplier Management Program . Software validation &

verification; defined/ tested

. Registered Agent Program; includes Service of . Medical foods &

Generally Recognized as Safe

Process, Secretary of State filings/ annual reports (GRAS)

designation requirements; Orphan Drug Act

. Enforced Unit-Dose Special Packaging reqmt's . Supported New Drug

Applications (NDA) & Abbreviated New

per Poison Prevention Packaging Act Drug Applications (ANDs);

complied with Prior Authorization

. Saved $6,900 1st yr. & $31,600 over 5 yrs. (PAS) & Changes Being

Effected (CBE) Supplements via

. Received 100% UL STR-R Audit score Chemical, Manufacturing,

Controls (CMC)

Quality Control Inspector (Weekends/ Contract); McKesson Corp.; Concord, NC

(01/2013 - 04/2013)

Assured FDA cGMP unit dose repackaging of DEA Controlled Substances (CI -

IV), OTC's, & Rx tablets:

. Verified proper set-up of packaging equipment, & cleaning of

packaging suite

. Accurately completed documentation; investigated/ determined root

cause/ corrective action; reduced NCR's

. Performed line clearances, in process, final product inspections, &

product releases

. Provided administrative/ documentation support to Quality Dept.

through product/ vendor spec's

. Communicated concerns to Supervisor regarding product defects,

errors, or personnel

Certified National Pharmaceutical Rep. (CNPRx) - Cert #: 579162011;

Washington D.C. (05/2011 - 11/2011)

REMeDI (Regulatory Environment of Medical Devices & Implants) - Grad.

Cert.; Buffalo, NY (09/2010 - 08/2011)

Principles of bio-materials science (chemical, physics, mechanical

engineering) as they relate to material interactions with cells, tissues,

and organs (biology, physiology, and biophysics):

. US & international bio-medical product regulations . Drugs, biologics,

devices, banked human tissue, & combination

. Classification; bench research; sterilization . Animal testing (pre-

clinical), clinical trials, manufacturing

. PMA, 510(k), IDE, IND, HUD, SE/ NSE Devices . Product development,

production, use, research, product

. Post-market surveillance & MDR; IRB's design &

labeling. ICH Q8, Q9, Q10; Pharmacovigilence

. Packaging Validation Protocol - tests for validating . IQ, OQ, PQ

protocols; Device Export Certificates

EMPLOYMENT HISTORY (cont'd):

Compliance Coordinator; Patterson Medical Supply, Inc.; Tonawanda, NY

(05/2007 - 12/2010)

Analyzed/ implemented state, local, & federal regulations for Prescription

Drugs/ Devices, Durable/ Home Medical Equipment (DME/ HME), Radiation

Emitting (X-Ray) Devices, EH&S, food & 130 indirect reports (record-

keeping); met licensing, registrations, & wholesale/ 3PL (Third-Party

Logistics) distribution regulations:

. Served as Management Representative . Served as CDR & Radiation

Safety Officer

. Quality Management System (QMS) designed/ . Trend Analysis/

reports for DEA Listed Chemicals/ Rx Drugs

authored; FDA's Quality System Regulations (QSR) . Medical license/

permit verification system for

. Medical device manufacturing; met physicians/ authorized

prescribers

FDA/ product specifications, released batches .

Training & tests creation; met ship/ pack regulations

. Adverse event (AE) & post-surveillance system . Pedigree/

Authorized Distributor of Record (ADR)

. DEA Suspicious order monitoring (SOM) . Product recalls/ field

retrievals with FDA & vendors/

consumers

. Hazardous, pharmaceutical, & medical device . Instrument calibration

management

disposal/ tracking; reverse distribution oversight . Drug storage

requirements; complied with USP-NF

. Device Master Records (DMR's), Design Output . Design History Files

(DHF's); Device History Record - reworks

. Purchasing Controls, Approved Vendor List . Labeling/

advertising (i.e., federal legends, intended use)

. Device specifications - drawings, composition, . Labeling

verification, printing, legibility & control

formulation, components & software control . Supplier Due

Diligence Program oversight

Aftermarket Planner Specialist; Cooper Turbocompressor, Inc.; Cheektowaga,

NY (01/2003 - 05/2006)

Appraised capacity & labor for 50+ union employees regarding OEM (Original

Equipment Manufacturing) of centrifugal & reciprocating compressors; units

supported key stages of lifecycle biologics and pharmaceuticals:

. Former Sr. Production Scheduler - Machine Shop . Pricing &

process resolution; budget compliance

. Identified/ planned for overload conditions; .

Contract Order/ Router creation & updates

included overtime and/ or outsourcing . Managed Customer Terms &

Conditions contracts

. Material Master Activation within SAP ERP System . Analyzed demand

and secured supply

. Existing/ re-engineered change management . Managed

material demand/ maintained inventory balances

. Lean manufacturing . Managed JIT inventory

of OEM manufacturing

. Project planning & critical path scheduling . Bill

of Material hierarchy, derived from

Material Supply Chain

. Vendor/ sub-contracting management . Purchase Requisitions/

Orders created

Inventory Control Coordinator; The Mentholatum Company, Inc.; Orchard Park,

NY (01/1998 - 01/2003)

Supervised 4+ employees; produced over-the-counter (OTC) pharmaceuticals

via cGMP, includes eye/ lip care, topical pain relief, & cough/ cold.

Managed multi-million dollar API's/ excipients, packaging, WIP, & finished

goods on-site & off:

. Label Storage access control - 0% misbranding . Staged material for

validation & production

. Master/ Batch Production Control Record review . Controlled Cycle

Count Program; reduced obsolescence

. Synced Line scheduling/ change-overs . Synced preventive

maintenance with Engineering Dept.

. Item Ledger Reconciliation . Inventory improvement

from 49% to 96%

. First-In/ First Out Inventory (FIFO) & FEFO control . Controlled

packaging & labeling materials for drug production

. Destroyed/ witnessed excess labeling . Created Quarantine

Area for drugs unfit for humans

DEGREES: . B.S. Degree in Management - Houghton College

. A.O.S. Degree in Computer Network Systems -

ITT Technical Institute (Honors)

COMPUTER . S.A.P., J.D. Edwards, AS 400, & M.X.P. Business Management

Systems; WebEx Telecommunication

EXPERIENCE: . LotusNotes; Microsoft Outlook, Project, Excel, Access,

PowerPoint, Word, & FrontPage; Sharepoint

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