Updated resume

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Jose D. Santiago, B.Sc.
Senior Consultant, phone:787-224-8044;email: josed52@aol.com
Mr. Santiago is an action oriented pharmaceutical, biotechnology and medical device professional offering a rich
history of success leading change processes and turnaround initiatives. He has project management expertise in
designing and implementation Batch/Devise Master Records, Product/Process Investigations and Technical
documentation processes including New Product implementations/product transfers in solid dosage/aseptic product
operations. He has hands on experience working with cGMP’s/QA Systems/Validation and companies that were under
Consent Decrees and Warning Letters. Mr. Santiago is highly skilled in directing and mentoring professionals in
achieving quality and operational targets.
AREAS OF EXPERTISE
 Quality Assurance
 Compliance
 Good Manufacturing Practices (GMP’s)
 Validation (CSV, Cleaning, Process)
 Pharmaceutical/Medical Devices Quality
Systems
 GMP/Quality Systems Audits
 Risk Management Process
EDUCATION
 Bachelor of Science in Chemistry/Biology,
University of Puerto Rico, Mayaguez, Puerto
Rico
 Certified GMP Trainer and CAPA/Risk
Analysis
 Certified in Complaints/Investigations/Root
Cause/Change Control
LANGUAGE
English
Spanish
EXPERIENCE
 Medtronic PR-Sr Compliance/Audit/Functional
Portfolio Manager
 Abbott (Chile)-Compliance Remediation Lead
 Novartis-GSK PR-Sr. CAPA/Investigations
 Smiths Medical MN and Mexico -Sr. QA
Consultant Complaints
 Baxter Jayuya PR/North Cove North Carolina -
Sr. QA Consultant/FDA Readiness Leader
 Actavis/Allergan (Fajardo PR)/TPI-Chicago USA-
Sr. QA/Tec Services Consultant
 McNeil Healthcare, Las Piedras PR- Consent
Decree Champion Director
 Amgen, Juncos PR-Sr QA Consultant
 Johnson and Johnson, Haina DR-Compliance
Remediation Sr. QA Consultant
 American Pharmaceutical Partner, Barceloneta
PR, QA/Tech Service Manager
 Cordis, San German PR-QAMentor Manager
 GlaxoSmithKline, Cidra PR-Sr. QA Leader-
Consent Decree
 Cordis, San German PR- WorldWide CAPA/QA
Systems Manager
 Taratec, San Juan, PR (Schering Plough PR)-
Consultant Project Manager
 Block Drug Corp, PR- Quality Assurance/Quality
Control Manager

2. Jose D. Santiago, B.Sc
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Career Detail
Baxter Jayuya PR/Baxter North Cove, North Carolina USA/Amgen PR/ Merck, LP-PR
/Smiths Medical MN-Mexico/GSK-Novartis/ Abbott (Chile)/Medtronic PR
Responsibilities:Sr. QA Consultant/FDA Readiness/QAComplaints/Investigations/Sr
Compliance/Audit/Portfolio Manager-May2015 to currently at Medtronic PR
 Quality Assurancerevision/approval of the different packaging processes andStandard Operating
Procedures-Amgen.
 Review and approvals of new Electronic Batch Records (EBR’s) for new product-Amgen.
 Support Warning Letter Remediation-CSV/Cleaning Validation Remediation process at Baxter
Jayuya-PR.
 Auditing facilities per FDA/ISO Aseptic Operations requirements-Baxter North Carolina.
 Quality Systems (Change Controls/CAPA’s/Investigations/Complaints-Baxter North Carolina.
 GMP/Quality Systems audit-Solid Dosage-Merck LP (PR).
 Smiths Medical MN (Medical Device)-Regulatory Compliance Remediation of the
Complaints/Investigations/Change Control/CAPA/Risk Management process at
Minnesota and Mexico (Tijuana) operations.
 Lead QA CAPA/Investigation process/Compliance-Abbott Chile
 Auditing/CAPA review/Plant Master File/FDA Readiness-Medtronic PR
Thera Proteins-Chicago (Jan to April 2015)/ Actavis/Allergan, PR (February to May 2015)
Responsibilities:Sr. QA/Tec Services Consultant
 Development of a Cleaning Validation and Process for Aseptic Manufacturing-Thera Protein
 QA Documentation Process review for FDA application approval-Thera Protein
 CAPA process completion-Actavis.
 Harmonization of the QA In Process System for tablets-Actavis.
McNeil Healthcare, Las Piedras PR, (July 2012-Dec 2014):
Responsibilities:Consent Decree Champion Director
 Led the integration of Consent Decree and Base Business team working process.
 Streamlined process to completebefore due date FDAwork plan Consent Decreerequirements
-McNeil PR. Serve as liaison with the third party-Quantic.
 Participate in the QA alignment process for Quality System elements per FDA Work plan.
 Mentorship of the new implemented processes and product re-alignment from US to PR.
Amgen, Juncos PR (Oct 2011 to July 2012)
Responsibilities: Sr. QA Consultant
 Participate in the QA/CSV approval process for SOP’s (review, approval and implementation),
manufacturing equipment characterization (FAT, URS, SAT), validation documents (IQ, OQ,PQ
and validation summary), commissioning documents (review/approvals), Maximo and test runs.
 Auditing and monitoring of the QA/Validation process for the parenteral operation.
 Led the implementation, inspection and auditing of the QAprogram at the components cleaning,
sterilization, and formulation areas for the aseptic manufacturing plant (AML 14).

3. Jose D. Santiago, B.Sc
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Johnson and Johnson, Haina-Dominican Republic, (Jul 2010-Oct 2011):
Responsibilities:Compliance Remediation Sr. QA Consultant
 Achieve proactive audits to improve investigations performance/approvals and timeliness
reduction/remediation process including implementation/approval of Change Control/CAPA
process.
 Mentoring/implementation of QA/Manufacturing personnel in QA processes as per CFR 21-820
Quality System Regulation. Implement a Cleaning Validation process.
 QA Implementation of Cleaning Validation/Documentation Process.
American Pharmaceutical Partner, Barceloneta PR, (May2009-July 2010)
Responsibilities:QA/Tec Services Manager
 Improved manufacturing and quality processes toeliminate manufacturing delays and customer
complaints using Risk analysis process.
 Led initiatives to decrease manufacturing downtime and increase QA process inspection.
 Developed a program for fast execution and approval of Standard Operating Procedures,
Validation Protocols, Process Investigations, Change Control and Risk Analysis processes.
Cordis, San German PR, (Oct 2008-May 2009)
Responsibilities:QA Mentor Manager
 Managed and executed the Global CFR QSR 820(CAPA/Change Control/NCR’s
implementation process). Review and approval of Part 11 assessments and CSVreviews.
 Establish the Validation Profile Records/Periodic Review Process for all CSV systems-allareas-
for GMP/Acceptance Criteria procedures for NJ, Mexico, PR and Florida sites.
 Establish the day to day review/approval of CSV Methodology/Process Validation process as
part of the company integration process CSV program.
GlaxoSmithKline, Cidra PR, (May 2005-Oct 2008):
Responsibilities: Sr. QA Leader-Consent Decree
 Establish Risk Analysis program for improvements/decision making in quality process.
 Mentor to QA, Manufacturing and Technical personnel in technical writing execution and
Change Control issues. Serve as liaison with the third party-Quantic
 Led the 20% reduction of manufacturing process investigations event-Avandia/Avandamet
tablets and the QA process integration to facilitate the approval of manufacturing investigations.
Cordis, San German PR (June 2003-May 2005)
Responsibilities: CAPA/QA IM Systems Manager
 Implementation of a CAPA Worldwide system and product impact assessment programs
including a Change Control program as per CFR QSR 820 and CFR 210/211.
 Support complete restructuring and development of Corrective/Preventive Action program
operations in 4 different devices operation achieving paperwork decrease and root cause
definition.
 Auditing of four different US sites to comply with the implemented CAPA program.

4. Jose D. Santiago, B.Sc
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Taratec, San Juan PR (Schering Plough Consent Decree-Manati PR, (Aug1998-June 2003)
Responsibilities:Consultant Project Manager
 Led the startup of the process/cleaning validation program services for PR including Change
control process trainings. Led the Consent Decree assignment at Schering Plough site.
 Managed and executed the remediation program for a steroid cleaning validation process.
 Cleaning Process validation implementation and laboratory testing.
 Execute the Incoming QA process investigation/CAPA process.
Block Drug, Humacao Puerto Rico, (1980-1998)
Responsibilities:QA/QC Manager
 Directed 35-person QC/QA team responsible for running an entire QA/QC program including
microbiology and chemical laboratories, in process and finished product testing, QA product
inspection and disposition and documentation control. Reported to QA Vice President.
 Managed plant research and development functions (new product and/or formula changes).
 Participate and coordinate NDA’s / ANDA’s / local product registrations.
 Direct the communication between corporate, local/federal regulatory agencies and MCA-UK
(Medicine Control Agency)
 Managed the start-up of tablet manufacturing operation (product/new methodology transfer).
Four new product formulas transfer to PR. Product transfer from Memphis to PR.
 Led the FDAinspection process and if necessary, any companyresponses to FDA observation.
 Direct the product transfer/ successful launch of 4 different solid dosage (tablets) from raw
material stages to final product including analytical testing completion (Nytol 25/50mg, BC
tablets, Phazyme and BC cores).