Deborah Ann Cenci

** ***** *****

Upper Saddle River, N.J. 07458

ad3avf@r.postjobfree.com

Cell: 201-***-****

www.linkedin.com/in/deborah-ann-cenci-38b5a49

CHIEF COMPLIANCE OFFICER ● MANAGING DIRECTOR ● VICE PRESIDENT OF REGULATORY AFFAIRS Consummate senior executive, international change agent and quality professional. Acknowledged globally for Regulatory Compliance excellence, while driving large scale cultural change that builds organization effectiveness that supports the highest level of quality within Global GxP environment for all processes, international and domestic programs for the development and manufacturing of all products. Highly skilled in over 5 Therapeutic Areas including Blood, Tissue, Plasma, and Bone – Stem Cell and CAR-T development & manufacturing expertise. Implemented regulatory and quality assurance programs for International Delivery Teams- CRO’s, IT Providers, CDMO’s, Digital AI and MedTech Operational Effectiveness from all third-party providers/manufacturers. Thought-Leader, Mentor and International Advisor for innovative new technology and processes. CAREER TRACK

Major Consulting Firm

A.V.P/Senior Director of Regulatory, Quality and Compliance North America Practice 2019/2020 – Present

(2019 – Consultant) (2020-Full-Time Employee)

• Developed over 7 New Service Offerings for Life Sciences Practice

• Expert in M&A activities for over 30 countries

• Regulatory Strategist for Korean Certification for Medical Devices

• Processed 356h, MAH and OPDP documentation for M&A activities

• Regulatory Advisor and Compliance Officer for Plasma Oversight Systems Outsourcing Project

• Regulatory Expert for oncology for Mast Cell Tumors utilized venom to reduce tumors.

• Manage Regulatory, Quality and Compliance Team on various major Pharmaceutical Accounts

• Manage the Regulatory, Quality and Compliance Practice in North America (US, Canada, Mexico) Division

• Prepared 510k and EU-MDR for over 16 countries for two SaMD applications

• Reviewed all SaMD Quality and Design Documentation including completed per country regulatory mapping

• Established Clinical Trials and Regulatory Strategy for Oncology and Pain Management for Animal Health

• Established Baseline for Global Medical Device Legal Manufacturer

• Worked on the first battery operated Medical Device for Respiratory Health for Nigeria and UK

• Performed as Compliance Officer/Advisor for Quality and GxP Standards

• SME for all Quality, Regulatory and Compliance Pre-Sales and Post Sales for 83 RFIs, RFPs and Proposals.

• Regulatory Expert on GxP related software such as Veeva, Trackwise and other applications

• Managed a team of 18 to close over 3,000 Medical Device and Rx Drug Product Complaints in 6 weeks

• Managed and Performed Advisory Services for closure of over 100 Third-Party Manufacturing Complaints and CAPAs in 2 weeks with a staff of 4.

• Authored new SOPs and Quality Manuals with associated process and training

• Trained over 200 consultants on regulatory processes including GDP and GxP.

• Trained internal pre-post business development of Plasma-Derived and Cell Regeneration therapies.

• Managed Process & Computer System Validation, Regulatory and Process Consultants.

• Perform duties as Global Regulatory, Quality and Compliance SME. DIVA PHARMACEUTICALS, INC. 2015 – 2020

Global Head of Quality and Regulatory Affairs and Consultant Acting CEO from 2016-2019 (former CEO retired).

CEO of RCS – Regulatory Compliance Services (a division of DIVA Pharmaceuticals)

(Prime vendor for NJMEP and United Nations for over 20 years)

• Developed third acceptable submission for FDA Approval for Cannabis Rx Drug.

• Major interaction with USDA for Cannabis based products.

• Regulatory Submissions for expansion for Cell Regeneration Laboratory Quality Program – CLIA.

• Managed the expansion of 10 newly constructed cell regeneration laboratory quality cleanrooms

• Established Regulatory Strategy and Quality for full-scale commercial program (utilizing dormant 20 Hospital Human Cells Storage Freezers).

• Assisted with CLIA inspections and reviews.

• Developed Allogeneic Cell Therapies – Quality Assurance and Regulatory Strategies for Commercial Programs

• Established Stem Cell Regulatory (5-6 years old) - Baby Teeth Donation Program

• Establish Commercial Regulatory Strategy for Bone, Blood and Tissue for Regenerative Medicine

• Established New Jersey First Research Cannabis Pilot with top food scientists (which became Rutgers Cannabis Program).

• Hands-On Submission and Regulatory Strategy on over 65 Biotech and Pharmaceutical projects.

• Performing all regulatory, compliance and quality functions for Oncology and Orphan Drugs.

• Processed NDA’s, BLA’s, IND’s, CPP, PSUR, and Annual Reports and other filings.

• Executed Clinical Trials from Molecule to Post Marketing.

• Conducted Clinical Trials in multiple countries and under country specific regulatory restrictions.

• Instructed, Mentored and Supported country specific personnel, CROs and national representatives.

• Worked closely with Chief Scientific Officer and Medical Affairs to implement new quality directives and processes to ensure compliance.

• Completed all necessary OPDP submissions

• Worked on various remediation programs with Client’s Warning Letters and Consent Decrees within Germany, Canada, and United States.

• Enabled standards, checklists, and tools to provide guidance to quality processes while providing oversight at various levels of the international team. o Conducted Lunch & Learn Sessions on various regulatory topics. o Provided Dry-Run Sessions on new Clinical Trials. o Trained team on EMA, MIRA, PMDA and Quality Design Methods. THERMO FISHER SCIENTIFIC – FAIR LAWN, NJ (left due to husband suddenly passing due to cancer)2014 – 2015 Global Head of Quality and Regulatory Affairs (India, China Canada, Australia, Europe, United States)

• Managed Global Staff of 150 plus people in all types of country specific quality and regulatory compliance standards.

• Implemented pre-inspection program to ensure no 483s are issued.

• Reduced cycle time in review of batch records and manufacturing data prior to production.

• Reduced rate of errors, which resulted in increased over all global production.

• Eliminated and addressed backlog of customer complaints.

• Reduced number of new complaints by assigning and training new Supplier Quality Auditors and Internal Quality Control and Assurance staff.

• Worked with third-party suppliers and internal purchasing and procurement to establish new quality standards.

• Baselined and monitored quality outputs across all products.

• Implemented and trained staff and supporting team members on six sigma values.

• Created, trained, and implemented Corrective Action, Preventive Action (CAPA) program to eliminate non-conformities and deviations.

• Improved documentation and controls.

• Established Audit schedule, pre-inspections, “Audit Readiness” Program and more robust training academy.

• Utilized state grant to provide training in ISO and other necessary programs.

• Reduced existing product recalls and missing responses to FDA by over 95 percent.

• Rebuilt working relationship with the FDA and DEA.

• Worked closely with CEO and Operations staff to establish tighter controls within each department and new SOPs and processes.

• Implemented Master Control document control and training modules for US, Belgium, and UK Quality Management Systems.

• Developed, trained, and implemented Global Compliance and Ethics Program.

• Conducted Global Compliance Investigations and Outcomes concerning violations of Corporate Standards and Processes.

• Enforced and trained employees, contractors, suppliers, and vendors to global, statewide, federal, and country- specific pertaining to ethics and code of conduct adherence.

• Managed Scientists, Medical Affairs, Chemists (Dry and Liquid) and Laboratory Personnel.

• Managed Global Laboratories in over 8 countries.

• Performed Global Submissions for Medical Devices, API, and Chemical Compounds. HCL TECHNOLOGIES, INC. – Florham Park, NJ (left due to husband being put on hospice) 2009/2010 – 2014 Principal and Chief Compliance Officer -- Global Life Sciences

• Right the First-time, on-time submissions and acceptance of NDA, BLA, PMA and IDE.

• Developed and coordinated all Global activities for successful submissions of NDAs and ANDAs.

• Strategic Leader for development pipeline from molecule to post-marketing.

• Anticipated FDA requirements during early releases.

• Created and established Process Quality Control Management on all Regulated Pharmaceutical, Medical Device and Biotech clients.

• Established Global Regulatory Affairs, Quality and Compliance Practice which yield over 3 Billion Dollars in Revenue.

• Performed all Audit functions and inspections.

• Build a team of Regulatory, CSV, Process Quality, and Compliance from 0 to over 18,000 Global Specialists.

• Responsible for all regulatory submissions.

• Global Leader for Regulated Training Academy for over 60 clients and 19,000 employees.

• Developed, implemented, and trained Novartis team and third-party consultants on CCEX (Change Control Excellence Program) for SDLC and Drug Development (Still used today).

• Worked with client base on Regulatory submissions (IND, ANDA, NDA, and MAA).

• Provide Risk Assurance expertise to internal and external staff.

• Trained and managed Regulatory Submission team for outsourced engagements on IND, NDA, ANDA, PMA and 510K.

• Managed reporting cycle for Drug Products, Annual Reports, Aggregate Reports and Periodic Safety.

• Acted as SME and Regulatory Affairs leader for all Business Development staff members.

• Thought-Leader for Global Regulatory Affairs, Compliance and Quality.

• Participated in product planning to assure timely, smooth, and efficient development of regulatory submissions for clinical trials and product registration.

• Recommended appropriate regulatory changes for labeling, manufacturing, and marketing to assure regulatory compliance.

• Develop regulatory approval strategies, timelines, and submissions, clinical study management and implementation, reimbursement strategies, liaison with regulatory agencies and corporate legal counsel, and compliance with quality system standards.

• Prepared Annual Reports, CBE Filings, Pre-Approval Filings, and all communications with Regulatory Authorities.

• Reviewed, conducted, and managed Vendor Audits, Audits, Validations, Training Programs, and Governance.

• Lead Compliance Officer for all in-house and subsidiaries.

• Ensured compliance and advised management pertaining to all regulatory issues.

• Provided leadership and strategic input for planning and implementing regulatory filings.

• Provided regulatory guidance to functional areas to ensure understanding and compliance with appropriate regulations and guidelines.

• Prepared all audit plans for internal and external sources. DIVA PHARMACEUTICALS, INC. 03/2000 – 08/2010

Global Head of Quality and Regulatory Affairs

• Single Point of Contact for all federal and state representation.

• Established and facilitated all commercial, regulatory, and clinical operational efforts in relation to ethics corporate development.

• Established, trained, and facilitated Corporate Compliance Committee.

• Close collaboration and active participation with executive management from all departments to evaluate tactical and strategic issues facing the company, including long term strategic planning, and associated departmental performance metrics, evaluation of market dynamics and clinical trends, and assessment of acquisitions, partnerships, and other new business development activities.

• Developed the company’s Code of Ethics for Interactions with Physicians.

• Drafted, submitted, and obtained acceptance of IND, NDA and ANDAs.

• Achieved an Excellent Reputation on all State and Federal Government Levels.

• Manage all global CMC submission activities (document developing, reviewing, quality checks, consistency, regulatory guidelines, content, supporting documentation, formatting, and coordination).

• Strong understanding of technical drug related reports (stability, validation, and manufacturing).

• Conducted over 78 audits in 2014, pertaining to CRO's, CMO's, Third Party Vendors and Suppliers

(International), API providers, Chemical Manufacturers and Supplement Suppliers.

• Established "Audit Ready" Training, Checklists, and Audit Tabletop Exercises on a Global basis.

• Conducted practice session for "Inspection Ready" to review policies, procedures and implementation guidelines for Region, State, Country, and Federal Regulatory Bodies.

• Wrote extensive Audit Reports that outlines Remediation Plans and CAPA program standards, tools, and review.

• Implement CAPA Programs that closed over 99% of CAPA's in two weeks.

• Assisted firms/partner firms with closing of FDA Findings and assisting them in responding to FDA with a robust and complete CAPA program.

• Assisted firms/partner firms in "Revalidation Programs" of their internal processes, IT systems, and overall reporting structure.

• Development closure plan to Consent Decree findings and established Global plan that was well received by the FDA.

• Responsible for negotiating all products labeling with FDA.

• Reviewed and approved all labeling for US and International submissions.

• Over 10 years of experience with direct oversight, review and approval of advertising and promotion materials for branded and generic product line.

• Positive interaction with Regulatory bodies in the United States and Internationally.

• Heavy interaction with CRO management at all levels within the U.S. and International entities.

• Reviewed & implemented Regulatory Strategy depended on FDA & other regulatory bodies changes in policy.

• Developed and established effective working relationship with FDA (CDER and CBER).

• Planned, organized, and implemented regulatory strategy for multiple business units per therapy groups.

• Established SOPs for effective operation of the Regulatory Affairs department.

• Primary liaison to OPDP for all promotion and advertising activities.

• Extensive IND and NDA submission experience.

• Successful 510(k) submissions for expanded indication for various devices.

• Established Design Quality Assurance function to monitor design conformance to customer and internal requirements from development of initial design specifications, through validation and verification testing, and through evaluation of postmarked surveillance information.

• Responsible for CMS, OSHA, and JCAHO.

• Responsible for the entire Quality and Regulatory Affairs Audit Schedule.

• Experienced with SPL and eCTD submissions & International submissions

• Obtained approvals to market products in Europe and other countries (non-U.S.)

• Managed up to 178 individuals – Consultants and Employees on various projects.

• Implemented Risk Avoidance Process within company guidelines to all entities.

• Reported all exceptions and implemented corrective action plan to instill and enforce policies outlined within the firm.

ERNST & YOUNG – NJ 1998 – 2000

Director (Life Sciences and Global Internal Applications)

• Managed the data extraction, transform, load, and (ETL) function of a Balanced Scorecard project that integrates planned and actual measures of HR, Sales, Financial, and Operation activities on a unified front-end application.

• Promoted to developed and implement Global Corporate Change Management System and interdepartmental compliance controls & standards.

• Managed deployment of infrastructure software.

• Managed configuration, planning, and training of corporate wide rollout to internal and external clients.

• Trained administration staff on all new functions and continued rollout for all networks, web servers and remote laptops.

• Tested performance and benchmarked optimization of all workstations.

• Managed certification efforts of all toolsets.

• Negotiated with senior management of client groups to sell services and gather business & data requirements.

• Managed the full lifecycle development of subscription services.

• Performed business requirement analysis that supported business intelligence and data visualization of sales and marketing campaigns.

• Managed 30+ Database Administrators that supported 24 x 7 Data Center and 4 Project Leaders.

• Managed and supported PeopleSoft Applications with Oracle 7.3.4 databases.

• Department support 195 internal Oracle databases.

• Received numerous rewards and bonuses based on achieving yearly KPIs in last than 3 months. COOPERS & LYBRAND 1997 – 1998

Practice Manager (Life Sciences and Consulting Practice) KEANE 1996 – 1997

Consulting Manager / Engagement Manager (National Accounts): EDUCATION

M. B. A. Finance (IP), Fairleigh Dickinson University - Teaneck, NJ B. A., Sociology, Fairleigh Dickinson University

• Designated Representative License for Rx Drugs – Florida, New York, and California

• Medical Device Certified for Device Designer (for Lasers)

• S.P.I.N. - Sales Training

• Professional Seminars, 1993-present:

o Controlled Substances Compliance Certificate

o Visionary Leadership, Developing an Organizational Culture o Top Management Re-engineering and Process & Computer System Validation

• Six Sigma – Black Belt & GAMP 5 Expert Level Advisor & Trainer

• Quality Assurance Drug Manufacturing Certificate

• FDA Regulatory Compliance Appointments on various committees

• HIPAA Awareness, Security and Privacy Training – Healthcare Expert

• Clinical Research Associate Seminar

• Healthcare- CMS - Medicare and Medicaid Representative (Lifetime) Authorized

• Veteran’s Medical Drug Submission Registration Representative

• American Indian Healthcare System Registration Representative

• Medical Device Reseller Certificate

PROFESSIONAL AFFILIATIONS & MEMBERSHIPS

• 2021-2022 – Regulatory Strategy and FDA Approach Volunteer Project Manager – DTRA – Decentralized Trials and Research Alliance

• 2021 – Guest Speaker on Regulatory Requirements for Clinical Trial Submissions in Animal Health for the University of Georgia – School of Veterinary Medicine

• 2022- Linked In – Regulatory, Compliance, Technology and Quality Influencer over 24,000 plus followers.

• 2014-2015 – Awarded New Jersey Quality Excellence in Commerce

• Advisor – Intergovernmental Renewable Energy Organization - Sustainability-Poverty Alleviation (2016-Present)

• Advisor – Healthcare Committee (Disaster and Humanitarian Relief – United Nations (2008 to Present)

• Managing Director – Regulatory Advisor E-Newsletter – Regulatory Sciences & Technology (2004 to Present)

• 2013 –2015 Guest Speaker – Global Clinical Operations Association in PA.

• 2011 – DIA Guest Speaker on Process Quality Management on Drug Development Portfolio Management in Europe

• 2011 – Guest Speaker for Oracle Life Sciences Conference in London

• 2009 – 2019- Key Company Representative to United Nations (Medical Supplies, Rx Drug, and Crisis Healthcare)

• Board Member of the New York Executive Club and New Jersey Executive Club (CIO Forum)

• 2004 – Present Founder and Executive Director – Medical Device International Industry Council

• 2007- Present Member, Association of Clinical Research Professionals

• 2010- Present Chairperson - National Association of Pharmaceutical Research and Regulatory Professionals

• 2007-2015 Chapter President of Project Management Institute – New Jersey Branch

• Keynote Speaker for ISACA - IS Audit Association- E-Security Presentation

• Founder and Director of Women in Network (WIN) - Ernst & Young, 1999- 2000

• Network Director for Office of Retention- CEO Committee - Ernst & Young, 1999- 2000

• Member, Project Management Institute and Data Warehouse Institute

• Feature Writer -Star Ledger -Special Edition - Computers, Careers and Compliance

• Executive Director, New Jersey Career Connection (NJCC)

• 2000-2012 - Ambassador of Commerce & Industry, Board of Governor’s Committee

• EPA Expert Award received for Developing NOx, SO2 and CO2 Calibration & Measurement Software for over 300 utility plants in the USA.

• Clean Air Act-EPA and State Supported Activities (College Intern) - Keynote Speaker for the Senate

• 2009- Expert Witness Profiler for Department of Justice – “How Pharmaceutical Firms Commit Medicare Fraud”.

• 2010 – Assisted FBI in “Understanding International Black-Market Patterns of Rx Drugs”. HONORS

• Awards from Various Countries (Haiti, UK, Dominican Republic, Africa Coalition, Chile, and Peru)

• Seasoned Co-Author of Various Textbooks (7) and Industry Books on Validation (3 Books) (1 still in Print)

• 2001 - Winner for National Technology Solutions Contest

• BERT - Management Team - International Project and Product -Ernst & Young, 1999, Entrepreneur of the Year, INC magazine & Merrill Lynch (used by Big 4 Consulting Firms for Consulting Billing).

• Keynote Speaker, Chubb Institute Alumni Association

• Keynote Speaker, National Association of Accountants

• Volunteer of the Year, The Bergen Record - Compliance

• Who’s Who Among Young American Professionals

• Who’s Who in Finance & Industry

• Interesting Fact: At the age of 17 – developed Automated Attendant Software V.0 (C++ and Oracle) (Got paid

$58,000 dollars).

COMPETENCES

Achieve Results Drives Growth Leads by Example

Inspires Others Confronts Constructively Gets it Done

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