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Manufacturing Operations Medical Devices

Covington, GA
May 15, 2024

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Jaime De Jesus

*.Experience in FDA, EU, Canadian, Japanese, Mercosur (Anvisa) regulations and guidance documents and WW Quality & Compliance requirements (JNJ).

2.Familiar with applicable sections of 21 CFR 110, 111, 117, 210-211, 600, QSR 21 CFR 820 (and 803, 806), ISO 9001:2015; ISO 13485, PICs, TGA; WHO requirements.

3.Experience in Manufacturing environments for:

1) Management of Pharmaceuticals (solid dosage -including immediate and extended-release products), liquids, aseptic operations, running DI and WFI water systems, terminally sterilized products (Steam, Dry Heat, ETO, Radiation), and lyophilization, and plant warehouses. Managed manufacturing operations of Schering Plough in Las Piedras PR manufacturing operations with 150 persons working in 5 shifts, 7 days.

2) Supervised Class I, II, and III Medical Devices and kit packaging operations

3) Management of tablet manufacturing operations for controlled release tablet drugs and encapsulation of drugs and OTCs Vitamin products.

4) Consumer products, DESI products DESI determination classifies a drug as either effective for one or more of its labeled indications or lacking substantial evidence of effectiveness for one or more of its labeled indications. Most DESI proceedings have been closed and FDA's findings have been published in the Federal Register.

5) Medical (Class 3) Gas Devices for infants.

4- Experience in start-ups in Pharmaceuticals, Medical Devices, (one of each) with successful FDA Audits (0 483s in initial inspection). The first was the MD facility, I was the first employee and hired, trained, set up the QMS for a process that was the result of the consolidation of 2 distinct operations in NJ and Texas. The second, a new section of an existing solid dosage operation with a new sterile operation with state-of-the-art equipment.

5- Three years of experience in R&D -CMC Small molecules drugs at RW Johnson Development, Johnson & Johnson.

6- Skills acquired during my career: (Engineering planning, equipment requisitions, problem solving, validation, compliance)

Quality Assurance and Quality Control- worked in Lab (microbiology and chemistry assays)

Quality Management- progressed from technician to supervisor, Quality lead, and Quality lead in Quality Compliance (J&J, Ikaria, Meda, and Saol Therapeutics, Inc.)

Business units’ relationships and support- Supply Chain, Engineering, HR, Corporate WW operations.

Communications- Worked with subsidiaries in 5 continents (J&J), leading implementation teams English, Spanish, Italian, Portuguese.

Industry standards- specifically in laboratory operations and medical device operations, along with biological operations.

Negotiation- example -dealt with contractual agreements with international partners to assure maximum quality and corporate goals were met. (Schering Plough).

Problem solving, worked with production, development, and technical services teams to address supplier issues with plans to address Quality Agreement and required compliance ISO standards (10993, Biocompatibility testing) that overcome product inventory crisis. (Schering Plough, Saol Therapeutics, Inc.).

Regulatory Compliance- worked in team that delivered CM&C documents and responded to FDA inquiries successfully to assure timely approvals (RWJ and Saol Therapeutics).

Supervisory Skills- Worked effectively with small groups (3 in Saol Therapeutics and large 7-day operations at Schering Plough, Las Piedras, PR with 150 employees, 5 shifts).

Familiarity with Validation- Sterilization (Steam, Dry air, EO, Radiation), software, cleaning, manufacturing process in Pharma and Medical Devices (EO and radiation sterilization).

Experience with FDA and International Regulatory bodies and compliance requirements in 30 plus years.

Product Complaint Process procedures and providing Training to PC technicians.

Experienced in CAPA process, investigations to determine root cause, addressing deviations and non-conformance in supplies and manufacturing.


Jaime De Jesus has a 30 plus year career in the Pharmaceutical (sterile and non-sterile products, medical gasses), Medical Device (catheters, stents [Combo Devices] and kits, class 3 automated devices, gas ventilators and associated devices), and Food and Consumer industry (Foods, nutritional and other consumables). I obtained my B.S. from the University of PR. I have 20 plus years’ experience in GMP auditing (21 CFR 110, 111, 117, 210, 211; 600; 820; ISO 9001, 13485, EU, TGA, Japan etc.). Have experience in cGMP Training of personnel.

Languages (spoken and written): English, Spanish, fully fluent, Portuguese (spoken only), Italian (read only).

Summary of Career Experiences:

Quality lead validation experience (process, including autoclave and dry heat equipment validation, EO sterilization validation, cleaning validation, software validation (GAMP 5), and Waterfall method), managed validation program for two start-up companies which ended in successful pre-approval inspections (No FDA 483).

Team member for design, equipment selection, and start up- new product/process line and facilities for a pharmaceutical and a Medical Device operations.

Startup- new business/service/function (Medical Device Mfg. Plant, class 3 sterile device)

Worked with situations to remediate compliance issues that led to Warning Letters with McNeil Pharmaceuticals (Consumer and OTC) and with Cordis (Combo Drugs, drug eluting Stent). With McNeil, the follow up FDA inspection was successful (no FDA 483), and with Cordis, the WL was lifted after 12 months and 3 site visits.

Turn around- poor performing business/service/function (product failure to meet Japanese specifications was corrected with process modification by a cross functional team)

Leadership of cross-functional/cross-company teams

International J&J expatriate and audits (Latin America- Mexico, Venezuela, Brazil, Argentina, and Puerto Rico)

Identified/implemented major process improvement to enhance product quality with automation and re-designed process.

Technical writing, preparation of regulatory documents, led CM&C team that provided content for NDA submissions. Lead team that wrote J&J Aseptic Processing Policy in 1996 (initial version), which included a group of J&J company experts.

Experienced Trainer in Validation, Compliance.

Solid knowledge of Quality Subsystems such as CAPA, Change Control, Documentation Control, and write-up of Policies, Procedures, Work Instructions, and their control within the Pharmaceutical and Medical Device environment. Familiar with conducting failure investigations, the process for determination of root cause, and the completion of the CAPA process to the efficacy determination and closure. I have worked in the Annual Product Review process, including the preparation of APR reports for management review. I have extensive batch record review experience, from development to commercialization, in devices and in pharmaceuticals and Biologics.

Lead Auditor for evaluation of Contract Manufacturers for Aseptic processing and Terminal Sterilization of products (for FDA/EU requirements) for autoclaves, dry heat ovens, dry heat tunnels, EO sterilizers)

oSterile production expert (clean rooms, aseptic techniques, product sterilization equipment and their validation, utilities (water systems, HVAC, compressed gases), product inspection [ampoules, vials, devices].

oSolid dosage experience (Compression machines (Tablets), capsules, fluid bed coating, blending, compression and capsule filling tooling controls, encapsulation process, product inspection, and packaging).

oExperienced in water systems (Purified water USP via mixed beds, reverse osmosis, and distillation WFI).

oChemistry and microbiology laboratories testing and methods.

oMedical Device ISO 13485 trained auditor with Certificate

oReview of Equipment (Autoclaves, Dry Heat, etc.) Sterilization Validation documentation (Life Cycle Approach: URS, FDS, GMP Risk Analysis and Traceability Matrix, FAT, IQ, OQ, PQ, CSV (GAMP) of automated equipment Part 11/ Annex 11); ISO 13485 and ISO 14971 for medical devices.

Green Belt trained in six sigma processes.

Managed manufacturing facility of over 150 employees, 24/7 operation for Schering Plough Las Piedras, PR, 1985-1992.

Familiar with ex-US regulatory agencies such as Canadian, EU, TGA, Japanese, MercoSur (Anvisa, Brazil) for both drugs and Devices.

Good writing and communication skills

Product complaint Quality lead, trainer, and SOP writer for Product compliant processing for drugs, medical devices, and biologics.

Employment History

7/2022-11/2022: SQA Senior Auditor: Conducted audits of these organizations: (Foods and devices)






05/2016-June 30, 2022: Quality lead, Saol Therapeutics: Head of Quality for US operations associated with combo product (drug-medical Device) and US distribution of Biologics (Hyperimmune). Supported startup operations at new Kitting operations site, providing QMS and NPD documentation including product specifications, and review of product documentation (DHRs and Biologics assessment of temperature excursions) to release to distribution. Prepared Supplier qualification for entry into ASL for components, and all QMS subsystems.

05/2013-May 13, 2016: Associate Quality lead, Meda Consumer: Head of Quality for operations in Marietta, GA. Facility. The company was in the consumer Market and Over the counter drugs, vitamins, and ointments. Supported startup operations at new Kitting operations site, and the release to distribution of the products. Oversight of compliance, supplier qualification, and all product QMS subsystems. Supported a call center for complaints and product ordering.

01/2013- 05/2013: Sole proprietor of Quality Multiple Services, LLC, providing Quality Systems consulting and auditing (supplier and internal) services for the pharmaceutical, Medical Device, and Consumer companies. Worked as contractor for SQA Services Inc., conducting Quality Audits in the Southeast USA.

9/2011 to 12/2012: Ikaria Lead Auditor: (Requested this role to relocate in Atlanta area, based in Suwanee, GA Ikaria RSC due to family member illness)

Auditor for the Ikaria supplier/vendor and internal auditing processes. Helped to prepare annual auditing plans, assuring all audits are conducted in a timely manner by selected and trained SMEs within Quality Staff. Assure that the Ikaria Supplier Program is functioning appropriately, updating applicable SOPs and forms, submitting monthly reports to executive staff. Prepare QTA (Quality Technical Agreements) templates and collaborating with company business development, manufacturing operations, and legal department, assist in preparing plan for deployment to suppliers (components, services, consultants), and CMOs; and renewals of these as warranted by business needs. Evaluate new suppliers, participate in SSTs (Supplier Selection Teams) and review of suppliers (MRBs) and annual site evaluations. Conducted Batch Record reviews of Ikaria products manufactured in CMOs for development purposes. I conducted technical audits of service providers (Laboratories, CMOs dedicated to Aseptic Processing and terminal sterilization using clean steam and dry heat sterilizers) to evaluate critical and high-tech operations that involved overall compliance of aseptic or sterile operations to current FDA and ex-US regulatory requirements.

4/2011- to 9/2011: Ikaria Site Quality lead, Port Allen Facility

Quality Operations (QC Laboratory, QA Operations, R&D Quality Support.

Quality System maintenance and all QC/QA related functions as they relate to site manufacturing operations. Led facility Quality group through successive and successful Australian TGA inspection and FDA PAI inspection (no observations noted).

10/2010 to 4/2011: IKARIA Corporate Quality lead-

Responsible for IKARIA corporate wide Quality Compliance which includes corporate administration site, (IT Systems and Services, Product Complaints and Safety and Surveillance, Customer Service, Supplier Management Systems), a Medical Device Manufacturing facility in Madison, WI., a Drug Manufacturing facility in Port Allen, Louisiana; an R&D Discovery operation in Seattle, Washington, and six major Regional Service Centers, across the USA. Responsible for internal and supplier audit programs, FDA preparedness, dealing with ex-US regulatory body inspections, and the approval of all policies, procedures, and other documentation (records, forms, service manuals). Supported implementation of major Computer software-based initiatives (e-CTD, Master Control QMS, all Software related activities for the IT department).

01/07 to 11/09: Consultant

12/09 to 10/2010- River’s Edge Quality Assurance Quality lead- (DESI DRUG Manufacturer)

Hired as consultant to mitigate River’s Edge Quality System issues after an FDA inspection. Implemented improvements in QC/QA related functions as they relate to Contract Manufacturing operations. Helped the Quality manager in FDA interactions, relationships, and communications as consequence of FDA 483 and Warning Letter related to inspection conducted in August of 2009. Prepared monthly update reports to the FDA Atlanta District Quality lead and drove corrective actions within the organization to avoid further FDA action.

07/09-9/09- Alaven Pharmaceuticals-(DESI Drug Manufacturer) Helped to have the organization have an FDA inspection preparation program, did write-up of policies and procedures for a robust Pharmaceutical Quality Systems based on the ICH Q10 Pharmaceutical Quality Systems document. Review of Quality documents, writing of Quality Systems documentation, consultant on regulatory and compliance issues, training.

08/09-11/09: ViveBio LLC (Medical Device Start-up Company). Constructed ViveBio Quality System based on current FDA regulations (21 CFR 820 and ISO 13485). Serve as quality and regulatory consultant for start-up issues ex-USA (China and Brazil).

1/07 to 4/09: QA and Technical Consultant, Alimera Sciences (R&D, Ophthalmic)

Main areas of work: Validation reviews, developing a Quality System, Quality Assurance, external and internal audits, approval of vital records and validation documents. I prepared APRs for the ophthalmic marketed product that belonged to Alimera.

1/1993 to 12/06: Johnson and Johnson, New Brunswick, NJ

2001-2007- Quality lead, Corporate Quality and Compliance WW (Domestic)

Compliance oversight of consumer, pharmaceutical and medical device companies within J&J family of companies and their compliance to FDA regulations in the USA (Janssen Cilag, McNeil Consumer, Ethicon Endo, Cordis) and applicable ex-US international regulations.

Supported major product launches, including the Cypher® Stent. I participated in the Cordis launch of the Cypher® stent, as a member of two of the compliance teams. These were Lab systems and Change Management, and remediation of combo drug/device products quality systems issues identified by FDA. Participated in compliance teams that responded to an FDA issued Warning Letter and contributed to resolution of computer systems validation issues in the Cordis Laboratories.

Conducted assessments and elevated issues of high compliance risk into Management Action Plans. I provided support (translation) for MD&D Complaint Vigilance and Drug Surveillance programs for Puerto Rico operations.

Coordinated training program translations in variety of languages, Spanish and Portuguese were my areas of main concern.

Earned J&J Standards of Leadership Award, May 2004.

6/1996- 1/2001: Johnson and Johnson, QCS Quality lead, Latin American Region (International)

I was assigned as the Corporate Quality representative that partnered with the Pharmaceutical, OTC, MD&D and Consumers regional operating companies in Latin America.

Helped to define and develop programs to enable Latin American consumer and medical device business to meet regulatory requirements to supply EU and US market.

Provided technical assistance, coordinated, and managed regional training programs on Corporate Quality Program, Process and Computer System Validation, and International Quality Compliance and Manufacturing improvement.

Promoted innovation and provided compliance support to ensure corporate and business goals and objectives. These included TRG/QCS processes and tools such as TRAC (automated audit program), MAARS (Management Awareness and Action Response System), Process Excellence (6 sigma), Cost of Non-Conformance, and IRPP (Recall Avoidance). Helped engineered compliance initiatives to prepare Latin American regional businesses to enter the EU and US market.

1/1993-6/1996: R&D RWJ PRI, Quality lead Pre-Clinical Development, Raritan, NJ

Led group of Scientists that prepared CM&C submissions for small molecule products. Obtained approval for 5 aseptically filled and terminally sterilized product lines.

Achievements included leading a team of experts in preparation of J&J Worldwide Policy on Aseptic Products in 1995.

Prior Industry Experience

1985-93: Schering Plough Corporation Technical Services Quality lead (Las Piedras, PR)

Made major contributions to addressing contractual quality demands from the Japanese Market. Initiated and implemented process improvements that corrected product failures. The product line, a sustained release drug product, contributed 35 % of the site’s annual business earnings.

1984-85: Smith, Kline, and French, Process Development Analyst

Construction, led start-up and validation of sterile operations facility. Facility was finished on time and on budget and passed FDA PAI (No FDA 483).

1982-83: Smith, Kline & French, Production Technical Coordinator

(Carolina to Cidra PR Production Site transfer - Part of team that designed and prepared for the start-up and validation of the aseptic processing area in the Cidra, PR facility. The facility was “state of the art” with automation of hot air sterilization Depyrogenation tunnels, automated Fedegari Autoclaves, and high-speed filling machines)

1980-1985: Alcon Labs- Facility Quality lead, Avitene ® Facility: First employee and leader for new Medical Device facility in Humacao, PR. Led the organization in recruitment and training of personnel, creation of Quality Processes and Quality sub-systems, documentation systems that addressed the FDA Medical Device Requirements. Facility was finished on time and on budget and passed FDA PMA pre-approval inspection (No FDA 483 issued).


BS, General Science, Magna cum Laude, University of Puerto Rico

Pre-Med Program, Major in Biology

References: Will provide upon request

1- Alpaslan (Alp) Yaman, Ph.D.

Principal Consultant

Biotech, Pharma & Device Consulting, LLC

(973) 896 – 8047

Alpaslan (Alp) Yaman, Ph.D. LinkedIn

2- Orlando Lopez

Data warehouse Records Quality SME


ASQ: American Society for Quality

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