Program and Project Management, Quality Management, Operations

Robert D. Marriott

Address: **** **** ******* ***, ********** Township, OH 45440

Phone: 937-***-****

Email: **************@*****.***

LinkedIn Profile: www.linkedin.com/in/robertdmarriott

Program and Project Management/Quality Improvement Leadership/Compliance Leadership

PROFESSIONAL SUMMARY

An experienced leader of Operations, Technical Support, Quality Assurance, and Regulatory Affairs in a highly regulated healthcare environment. Proven program and project management skills and both mid-sized and large corporations. Technical and management experience in Medical Devices, Biologics (Blood and Tissue), Clinical Diagnostics, Organ Donation, and Clinical Research. A track record of finding creative solutions that allow innovation and drive efficiency while maintaining high quality and impeccable compliance.

Met or Exceeded Incentive Goals each of the last 8 years.

Have successfully led the integration programs of multiple organizations due to mergers and strategic alliances.

Reorganized failing departments/territories at 3 different companies into customer service focused organizations with high employee retention

Implemented continuous improvement activities (lean and six sigma methodologies) in a highly regulated healthcare environment.

Has lead, facilitated, hosted over 50 successful inspections and audits over the last 15 years.

Successfully launched 3 enterprise IT systems (and upgraded 2 others) for managing quality systems across operational departments and sites.

SKILLS & EXPERTISE

Program and Project Management – RABSQA ISO 9001/13485 Lead QMS Auditor – Negotiation with State and Federal Agencies – Integration of enterprise software into operations – Lean and Six Sigma methodologies – Regulatory submissions – QMS Integration of new acquisitions into operations – Mentoring and coaching – Data mining, statistical analysis, and modeling – Strategic Planning and Strategic Deployment

PROFESSIONAL EXPERIENCE

BloodCenter of Wisconsin, Milwaukee, WI:

Director – Quality and Regulatory Resources, 2009 – Present

Developed a Quality Assurance, Regulatory Affairs and Safety team from one that was primarily responsible for blood banking compliance in 2009 into a professional, collaborative, and continuous improvement focused team providing support and oversight to all BCW's service lines including transfusion medicine, therapeutic apheresis, transplantation, clinical diagnostics, and clinical research. The compliance and regulatory team supports growth of strategic initiatives, leads system integration of new service lines, and supports out of state affiliates and manufacturing sites. Budgetary responsibility for ~$1.8 million in expenses and $100-500 thousand in capital spending each year.

Quality Assurance Responsibilities

•Independent QA oversight to all BCW activities.

•Environmental, Health, and Safety Department.

•Lead BCW Internal Audit Program.

Compliance and Regulatory Affairs Responsibilities

•Regulatory Affairs Department, including FDA and State Licensing and Submissions.

•FDA Regulations related to Pharmaceutical, Tissue, and Medical Device related operations.

•Accreditation standards including CAP, AABB, AATB, AOPO, FACT, ASHI.

•HIPAA compliance and information security (policy development, training, audit).

Clinical Research Compliance Responsibilities

Implemented and maintained the BCW clinical trials compliance program. Our CRO at BloodCenter of Wisconsin and its Blood Research Institute (which is closely affiliated with the Medical College of Wisconsin) currently supports approximately 80 ongoing basic research trials, phase I and II drug trials, medical device trials, and post market monitoring trials.

IND submission and management.

cGCP, cGLP, ICH, Human Subject Research Compliance.

IRB oversight.

Host FDA BIMO and sponsor inspections related to our trials (~10-20/year).

Program and Project Management Responsibilities

•Due diligence assignment for strategic partnerships and mergers.

•Lead system (IT and operational) integration activities across strategic alliance partners.

•Lead/support operational integration activities across strategic alliance partners.

•Develop, deploy, and support 4 enterprise IT systems supporting the quality management system.

BloodCenter of Wisconsin, Milwaukee, WI:

Quality Systems Analyst/Project Manager, 2007 – 2009

Project management, system administration, implementation of IT and manual systems supporting the BCW Quality Management System including CAPA, Training, Document Control, and Process Monitoring. Responsibilities included:

•Lead implementation, maintenance, and improvement of Quality Systems throughout the organization.

•Lead implementation, maintenance, and improvement of Enterprise Quality Management Software.

•Lead Cross Functional and Organization-wide Quality Improvement Projects.

•Integrating Lean, Six Sigma, and other improvement tools to drive operational improvement projects.

GE Healthcare, Wauwatosa, WI:

Program Manager, 2006 – 2007

Serve as subject matter expert for production and process control quality management system, and ensure compliance of 25 manufacturing sites with Corporate Procedures and US and International Regulations related to Medical Device Manufacturing.

•Global operations and FDA regulated manufacturing system integration and standardization

•Lead corporate standardization of global manufacturing defect and scrap policies.

•Lead Auditor for GE Healthcare internal audit program.

•Support FDA, Third Party, and Corporate audits of manufacturing sites.

Abbott Laboratories, Abbott Park, IL:

Manufacturing QA Manager, 2004 – 2006

Lead Manufacturing QA team consisting of 4 QA Section Managers and Supervisors and their related direct reports responsible for manufacturing record review and approval, site quarantine, oversight of site operations from raw material production through distribution operations of medical diagnostic tests.

•Review and approval of site QA policies and procedures.

•Budget responsibility for a department budget of >$1,000,000.

•Member of Site Management Review Board.

•Manufacturing QA representative for internal and external inspections/audits conducted by division, corporate, FDA, and/or other regulatory bodies.

Abbott Laboratories, Abbott Park, IL:

Product Quality Assurance Professional and Project Manager, 2002 – 2004

•Product complaint management including investigation and customer communications.

•New product compliance to internal requirements and US and international medical device regulations.

•QA review of final product labeling and regulatory submissions (510K, PMA/PLA).

•QA Reviewer for reviewing investigations of product failures.

•QA representative for internal and external inspections/audits.

Abbott Laboratories, Abbott Park, IL:

Product Manager and Project Leader, 2000 – 2002

Technical Support product manager for cancer diagnostic assays used in the diagnosis of cancer including PSA, Free PSA, CA 19-9, CEA, and AFP. Launched three new or reformulated products to international market.

•Primary responsibilities included R&D transfer of new products and formulations to operations, manufacturing scale-up, coordinating complaint investigations, manufacturing support, and process optimization.

•New Product Development and Launch including preparation of regulatory submissions.

•Coordination and execution of pre and post-market clinical studies.

Caltag Laboratories, Burlingame, CA:

Midwest Territory Manager, 1998 – 2000

Served as sales and technical support manager for a small company that sold specialty products into the clinical diagnostic and medical research markets. This was a challenging market to sell into since the two largest competitors sold the instruments that our reagents ran on. Even with this challenge, I exceeded my sales goals and grew my territory by greater than 20% each year.

•6-state sales territory (Great Lakes Region) and 22 state technical support territory.

•Developed new promotional materials and marketing strategies used company wide.

Karmanos Cancer Institute, Detroit, MI:

Research Assistant, 1994 – 1998

Research focused primarily on developing investigational cell line models and flow cytometry assays for use for the evaluation of clinical research samples for Acute Lymphocytic Leukemia, Breast Cancer, and Squamous Cell Carcinoma of the Head and Neck.

•Lead technician in Karmanos Cancer Institute’s Core Flow Cytometry Laboratory

•Lab management (purchasing, training, safety).

EDUCATION & CERTIFICATIONS

Bachelor of Science, Biochemistry – University of Detroit-Mercy (1996)

Master of Business Administration, Economics – University of Michigan-Dearborn (1997 Incomplete)

PROFESSIONAL DEVELOPMENT

Abbott Diagnostics Green Belt, DMAIC, and Design for DMAIC training

GE Healthcare Work-Out and Change Acceleration methodologies

BloodCenter of Wisconsin Continuous Improvement Program (Blended Lean/Six Sigma)

ASQ Lean Six Sigma Training for Healthcare

RABSQA Lead Auditor (ISO 9001, ISO 13485, and 21 CFR 820)

Quality System Requirements and Industry Practice (21 CFR 820), Association for the Advancement of Medical Instrumentation (AAMI)

Prenatal Screening for Neural Tube Defects and Downs Syndrome, Foundation for Blood Research (FBR), Scarborough, Maine

MEMBERSHIPS

Member – Association of Clinical Research Professionals (ACRP)

GP43 Laboratory Standard Development – Clinical Laboratory Standards Institute (CLSI)

Senior Member – American Society for Quality (ASQ)

Member – Regulatory Affairs Professionals Society (RAPS)

Member and Institutional Representative – AABB - Advancing Transfusion and Cellular Therapies Worldwide

Member – American Association of Tissue Banks (AATB)

Member – Wisconsin Association of Blood Banks (WABB)

AWARDS AND RECOGNITION

Tibor Greenwalt Leadership Award Selection Committee (2013-Current), BloodCenter of Wisconsin – Committee of 3 responsible for reviewing nominations and vetting candidates for lifetime service award.

Operations Council – Leadership Committee 2010-2011.

BloodCenter of Wisconsin – Selected to be leader of cross-functional team tasked with driving organization wide improvements and cost savings.

Abbott Diagnostics Division Director’s Award for Process Improvement (4th Qtr 2005).

Abbott Diagnostics Division Vice President’s Award of Excellence (3rd Qtr 2003, 4th Qtr 2003, 1st Qtr 2004, 1st Qtr 2006).

PUBLICATIONS

1.R. Marriott, N. Steffen. The Art of Validation. WABB Annual Meeting, 2011

2.R Marriott, M. Wartick. Continuous Improvement Application in the Blood Banking Environment. 2009 PhARMA Conference for Blood

(Note: Following published as Robert D. Johnson, prior to change of name at time of marriage)

1.D. Stredler, R. Olson, C. MacCrindle, P. Roth, R. Johnson. The Abbott ARCHITECT i2000 System and Consistency of Tumor Marker Assay Reagents. XXIX ISOBM Meeting, 2001.

2.Zormeier, M., Shibuya, T., Wei, W. Johnson, R., Mathog, R., June, C., Lum, L. Anti-CD3/CD28 Suture Coated Co-Stimulation Produces IL-2 and IFN-gamma increase in HNSCC Patients. Academy of Otolaryngologists Annual Meeting, 1998.

3.Ratner, S., Johnson, R., Lichlyter, D. Neoplastic Models of T-Cell Polarization. FASEB, 1997.

4.Shibuya, T., Wei, W. Johnson, R. Meleca, R., Zormeier, M., Mathog, R., June, C., Lum, L. Anti-CD3/CD28 Bead Co-Stimulation Overcomes Regional Immunosuppression in HNSCC (Head and Neck Squamous Cell Carcinoma) Patients. ARO 1997.

5.KuKuruga, M., Tomur, S., Johnson, R., Tait, L., Lee, Y., Krishan, A. Flow Cytometric Determination of Estrogen Receptor Expression in Human Breast Cancer. AACR 1994

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