Senior Director of Quality - Blood Systems Inc
Willoughby, OH 44094
Senior Director of Quality
Blood Systems Inc - Elyria, OH
May 2015 to Present
• Integrated blood bank acquisitions in Ohio and New Jersey in under 18 months.
• Implemented TrackWise at 9 fixed site locations in Ohio and New Jersey.
• Launched projects to depot injectable pharmaceuticals in all distribution sites in the district.
• Successfully hosted 4 FDA inspections, and 5 notified body inspections (New Jersey Department of Energy, AABB, NMDP, HRSA and New Jersey Department of Health)
• Launched HIPAA/Privacy program in the eastern district. Served as Chief Privacy Officer.
• Sponsored project team seeking BLA for HPC Cord Blood (90% complete to date).
• Headed project team which implemented pathogen reduction technology for plasma and platelets.
• Served as chair of the Quality Team of the eastern district.
• Implemented Quality Incentive Program
• Served as Quality Head on launch of new BECS platform in New Jersey.
• Managed an annual operating budget of $1.1M.
• Oversaw all clinical trial activity in the eastern district. Lead Liaison, Regulatory Affairs - International
Dealers and Ministries of Health
May 2013 to Present
• Responsible for international registration of medical devices in EMEA; liased with all marketing units and business management to prioritize provide timely, compliant launch of medical devices in foreign markets. Successfully registered 250+ Class I and Class II devices.
• Managed/Liaised with 78 EMEA Country Managers, Dealers and Ministries of Health.
• Responsible for creating and populating a core database for regulatory knowledge in all countries.
• Responsible for developing successful, comprehensive regulatory strategy for each EMEA country.
• Trained and qualified as an EU MDD subject matter expert, knowledgeable in CE marking, Technical File Development and Declarations of Conformity.
• Serve as a group-lead/mentor to Specialists and Senior Specialists in the department, and a functional lead to all marketing teams and business units of the EMEA.
• Executed continuous improvement projects for managing expiring registrations, harmonizing Declarations of Conformity and managing Device Technical Files. Identified key countries of market importance, and executed periodic reviews of the regulations and regulatory environments. Effectively communicated changes in international regulation to upper management. Director of Quality and Compliance
DCI Donor Services - Nashville, TN
September 2014 to April 2015
• Implemented a reorganization to create a compliance department. Created tiered job descriptions with a technical path for advancement for associates.
• Expanded the internal audit program by 400%.
• Initiated a cultural shift towards Quality via setting yearly thematic goals, increasing quality presence in the processing facilities, using the shock value of problematic case review, and creating strong positive relationships with middle management.
• Managed an annual operating budget of $1.8M.
• Created an integrated supplier management program to consistently track and trend quality and key deliverables.
• Executed 2 Kaizen events, which resulted in a savings of 141 man hours in Quality Record Review.
• Undertook a massive validation effort to identify outages and address all unvalidated equipment and processes.
• Harmonized Ocular Tissue Processing procedures and policies corporate-wide.
• Created systems for tracking and trending FDA reportable events, UNOS allocation inquiries and third party audit findings.
• Strengthened weak departmental employee engagement via an Outstanding Performance Award system, and via Community Service Projects.
STERIS, Inc - Mentor, OH
November 2011 to August 2014
Manager, Regulatory Compliance
August 2012 to May 2013
• Responsible for managing remediation and compliance efforts associated with FDA Consent Decree.
• Managed up to five direct reports, with an operating budget of approximately $500,000 annually. Mentored the full-time associates consistently; one associate achieved promotion to Senior Specialist.
• Oversaw the effective operation of the Corporate Reportable Event Committee (REC); created system of monitoring social media for reportable events.
• Assisted in the coordination of notified body audits and liaised with numerous site Quality Managers to ensure corporate readiness for audit. Participated during numerous customer and agency audits to support discussions around areas centralized in the Regulatory Affairs Compliance group - MDRs, Field Corrections/Recalls and Internal Audits of the site's quality system.
• Responsible for monitoring the release of new/revised regulations and standards and recommending changes if necessary to ensure continued compliance.
• Responsible for SOX/Financial auditing corporate-wide
*Note of clarification: In May 2013, the Regulatory Compliance Department was eliminated in a corporate reorganization initiative.
Lead Specialist, Regulatory Affairs
November 2011 to August 2012
• Collaborated on the compilation and review of regulatory submission packages, including traditional, special, abbreviated and de novo 510(k)s. Managed inter-departmental work groups to facilitate the generation of submissions. Responsible for writing and editing the finalized submission. Responsible for developing sound regulatory strategy for individual projects and associated 510(k)s, to achieve speedy clearance and market launch.
• Monitored pending regulatory submissions. Interacted with FDA on requests for additional information and/or clarification.
• Created/Managed a system for managing FOIA and MDUFMA requests, and hardcopy and electronic libraries of competitor submissions.
• Responsible for hosting regulatory inspections, and direct interactions with the agency.
• Lead a large inspection readiness project to identify and address quality system deficits associated with current consent decree.
• Created a training matrix for the regulatory affairs department, and templates for training file management.
• Served as the regulatory liaison for a large, corporate-wide electronic documentation/design management system implementation.
• Regulatory Liaison for Latin American manufacturing.
• Serve as GLP/GCP Subject Matter Expert for Regulatory. Global Clinical Quality Lead / Clinical Quality Assurance Auditor Legacy Kendle, Inc - Cincinnati, OH
May 2010 to November 2011
• Executed GCP audits including electronic data capture, training, trial master file, institutional review board, clinical investigator, and vendor audits.
• Participated as a Clinical Quality Assurance Chair representing North America and Latin America on the Vendor Management Committee. Reviewed quality and business assessments. Assisted in large optimization project to identify and address strengths, weaknesses, opportunities and threats to the overall system.
• Hosted successful regulatory agency inspections in Latin America, and served as a quality liaison to Latin American Operations.
• Directly facilitated multiple successful study specific third party audits and MoH inspections.
• Created new procedure for pediatric informed consent, which incorporates blended families/joint custody situations.
• Utilized as a pre-clinical/GLP subject matter expert, and Part 11 compliance support.
• Served as the Global Quality Lead on four on-going clinical trials.
• Successfully remediated 483s and Warning Letters leveled against Principal Investigators and Customers.
Quality Assurance / Regulatory Compliance Manager
Cardinal Health - Zanesville, OH
June 2009 to May 2010
• Managed a crew of five full-time quality assurance associates.
• Created a program for submissions to the new FDA Electronic Submissions Gateway (ESG). Trained as subject matter expert on the ESG. Executed training of staff as well.
• Qualified direct reports for external auditing.
• Created a Site Quality Manual.
• Revised Supplier Quality Program. Executed numerous vendor audits.
• Initiated drug insert review via software; upon completion of project the company cost savings were projected to be between $15-30K per year.
• Served as Quality Lead for feasibility, development and launch of liquid oral dosage fill line.
• Moderated Site Diversity Round Table; initiated a Women's Network as an Employee Resource Group, and facilitated continuing education and activities for inclusion and diversification of workforce. Senior Compliance Associate
June 2007 to April 2009
• Assisted in the development of quality systems including Supplier Quality and Vendor Complaints Programs. Created programs for debarment verification, GLP Management and a GxP Committee.
• Served as the Chair for the Vendor Complaints Committee; managed the program (processing, investigating and resolving vendor complaints).
• Assisted in processing, investigating and closing adverse events and product complaints.
• Performed external audits assessing vendors, both domestic and international (GMP, GLP and general quality audits).
• Managed five teams of independently contracted auditors to execute vendor audits (GMP, GLP and general quality audits). Processed purchase orders, invoices, and managed reporting and responses.
• Responsible for departmental budget development.
• Promoted from Compliance Associate I to Compliance Associate II in 2008. Promoted to Senior Compliance Associate in 2009.
Alkermes, Inc - Wilmington, OH
September 2005 to April 2009
September 2005 to June 2007
• Developed several types of documentation including (but not limited to) SOPs, corporate guidelines, forms, batch records, material specifications, functional requirement specifications, user requirement specifications, engineering studies, validation reports.
• Completed a large project in which all necessary Engineering Studies, IQ/OQ/PQs, preventative maintenance and operational SOPs were created for a new, fully automated aseptic fill line. Education
Bachelor of Science in Biology in Biology
Indiana University (East Campus)