ROBERT TAWODA *** Upper Darby, Portage, MI, *****

269-***-**** adxsgm@r.postjobfree.com

KPI’s

Clinical & non-Clinical pharmaceutical and medical device research (8+ years)

Monitoring, Auditing, Vendor/Supplier Qualifications (10+)

21 CFR Part 11; 58; 820; 312; 314; 600’s; 210/211 — (10+)

Hiring, Training & Managing, Technical & Scientific personnel (15+)

Pharmaceutical and Medical Device manufacturing (9+)

Quality Management & personnel development (10+)

CER design and management ( 3MM)

Business Process Improvement (BPI)

CQA® & Six Sigma™ certification(s)

Trackwise® (10+ years)

o ISO 13485:2016 (Lead Auditor Certification); 9001; EU, CLIA, COLA, and PPTA – additional regulatory body-proficiency

EDUCATION

Biology; Minors in Marine Sciences, Chemistry

Salisbury University, Salisbury, MD (1997)

International Business

Loyola University in Maryland, Baltimore, MD (1994) PROFESSIONAL

09/20 - Current STRYKER CORPORATION (Kalamazoo, MI) SR. SPECIALIST QMS (03/21 – CURRENT)

IMTE and calibration system management of SMK sites including >9000 calibrated assets o Vendor evaluation, selection, qualification, auditing, and monitoring o RFID tracking program implementation

o Development of a secure, dedicated storage facility to enhance traceability, tracking and minimize excess gage costs

o Waste reduction / Cost reduction for calibrated IMTE, 15% 2022 vs. 2021; 12% in 2021 vs. 2020

6S project initiative Q3 ‘21 /completion Q1 ‘22, providing $72k in savings for 2022

IS change control assessment and approval; system integration, QMS system modifications

Lead Auditor ** Internal and External Audit management team, including Domestic and non- Domestic regulatory audit intervals, remote or onsite

Document Control Czar for Windchill™

Site access liaison for two merging QMS systems / sites QUALITY ASSURANCE ENGINEER, INSTRUMENTS (09/20-02/21)

New product development & manufacturing transfer of M & A product lines

Integration and adaptation of acquisition documents, procedures, protocols, MAP documents, that meet or exceed established Stryker guidelines for production part receipt, inspection, and utilization

Identification, mitigation, & closure of deviations associated with new acquisition product(s) via Trackwise®

Fostering collaboration between internal and external engineering groups, production team members and quality personnel, to resolve transfer challenges within an accelerated manufacturing schedule

11/17 - Current GERSON LEHRMAN GROUP (remote)

CONSULTANT ONLY

Private / contract-for-hire, consultant for international blood plasma manufacturing companies seeking expert knowledge, including but not limited to, quality procedures, multi-national regulatory standards, and operational milestones.

10/18 – 05/20 PRAXIS PACKAGING SOLUTIONS (Grand Rapids, MI) QUALITY SYSTEM MANAGER

Lead product launches and ensure compliance with 21CFR requirements and internal Quality Management System standards.

Developed regulatory and validation procedures for packaging procedures. Metric development and analysis of operational processes, deviation management, product packaging recall processes, and system validation procedures.

Responsible for PPAP - production and packaging line design, aseptic process design and implementation; finish packaging certification in alignment with FDA approved specifications; change control identification, design and submission.

Hiring and development of QMS division staff (14-18 employees). Maintain Quality and Regulatory systems during customer and agency on-site audits (10-12 per calendar year). 09/16 – 07/17 BPL PLASMA (Austin, TX – remote)

FIELD QUALITY MANAGER

A Quality manager for 8+ plasma donation centers, working remotely from Michigan with 75% travel

requirements.

Work with center management personnel and the Regional Operations Manager to ensure full data integrity and full audit readiness for each plasma center (FDA, EU/MHRA, IQPP, OSHA, CLIA, COLA, customer audits, and other regulatory agencies as needed).

Develop, revise and administer SOP’s and organizational policies. Identifying areas for fleet-wide quality improvement projects and CAPA solutions for continuous improvement.

Regularly scheduled meetings with center-level and Senior Executives to drive excellence in Quality.

01/15- 9/16 PERRIGO (Allegan, MI)

QA SUPERVISOR II

A member of the Quality management team, Liquid Value Stream division

Working in constant cooperation with the operations group to achieve our right-first-time objective utilizing cohesive teamwork to exceed customer expectations by providing exceptional products

Deviation documentation, situational analysis and investigation, and deviation closure

A3 project delivery

06/10 – 12/14 OCTAPHARMA PLASMA INC (Kalamazoo, MI) CENTER DIRECTOR

Manage all staff and all center operations, including but not limited to, production, quality, finance, and HR functions (50+ donor center personnel).

Responsible for corporate functions to ensure center compliance and optimal performance under all conditions.

Exceeded production forecasts while maintaining an under-budget facility (4+ consecutive years). Pristine facility audits via all regulatory agencies including the FDA, EU, CLIA, COLA, and PPTA.

05/02 - 03/05; MPI RESEARCH INC (Mattawan, MI)

04/06 – 11/09 STUDY DIRECTOR

Coordinated and managed multiple non-clinical research studies in accordance with FDA cGLP guidelines.

Planned and implemented operational aspects of surgical research studies.

Developed study protocols for: med devices, drug delivery systems, bioengineered implants, dermal applications, and general toxicity programs.

Served as liaison with clients, delivering status updates and implementing project changes.

Developed cross-functional collaborations with other departments to ensure projects were on time and within budget.

Performed critical analysis, evaluation, and documentation of data. PROJECT LEADER, TEST MATERIAL CONTROL DEPARTMENT

Initiated, led, and managed non-clinical research projects in accordance with FDA and GLP guidelines. Evaluated client needs and developed study proposals, including study protocols and practical applications.

Served as liaison with clients, delivering status updates and implementing project changes.

Developed cross-functional collaborations with other departments to ensure projects were completed on time and within budget.

Designed and implemented SOP’s.

Designed and verified formulation methods that comply with study protocol, SOPs, and FDA guidelines.

Performed critical analysis, evaluation, and documentation of data.

Trained and managed technical staff of up to 20 research associates.

Facilitated critical shipments clients in strict adherence to US Customs and DEA guidelines.

Interacted with DEA and US Customs on behalf of MPI Research. 03/05 - 04/06 BOSTON SCIENTIFIC CORPORATION (Maple Grove, MN) SENIOR RESEARCH ASSOCIATE – INTERVENTIONAL CARDIOLOGY Identified, awarded, and monitored laboratories across multiple US and International sub-contracted locations, ensuring full compliance with Boston Scientific guidelines.

Conducted laboratory audits with surgeons to assess lab capabilities, evaluate qualifications and deficiencies.

Supported report preparation and agency submissions.

Assessed viability of subcontractors to facilitate testing of medical devices, drug delivery systems and primarily, non-routine surgical research protocols. COMMUNITY

Western Michigan University, Kalamazoo, MI (2003-2005)

Head Coach (Men’s Lacrosse) MCLA Nationally Ranked Program Consisting of 42 Full- Time Student Athletes.

American Heart Association Community and Corporate fund raising leader (2012-)

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