SUMMARY:

• A Senior Risk, Compliance, Regulatory Affairs & Program Management Lead serving cross functional industries.
• I build Compliance by design products as a liaison between Legal, Business, IT, PMO, Sponsors, Regulatory agencies (FDA, SEC) with strong cross functional collaboration.
• I intend to parlay my unique combination of business\risk management and technical expertise into a leadership role.

COMPETENCIES:

Program/Project Management

Compliance & Regulatory Affairs

Financial Risk Management

NIST, HIPAA, SEC/NFA Guidelines

Privileged A/C & SOD

Mergers, Acquisitions & Integrations

Vendor Management

Cross Functional Leadership

Asset Governance

Business Continuity\DR

CoBiT 5.0, COSO, 21CFR Part II

Identity Access Managment

Audits and Assessments

ISO 14971, ITIL, PCI, PII, SPII

On Shore/Offshore Model

Sox 302, 404, SAS 70 (SOC1)

ICH, Q9, ISO 17799, ISO 27001

Defense Risk Assessment

Metric Stream, Archer, GRC

Presentations & Seminars

CAPA, Risk Analysis, Mitigation

Data Migration & Analysis

EXPERIENCE:

Confidential, New York, NY

Lead, Risk Management & Compliance

Responsibilities:

• Information Governance and Management (IGM) compliance function reports into the CIO and covers Information Security, IT and Risk Management, Compliance (GxP).
• Standardize and Streamline the IT Landscape, drive business innovation through Digital and strengthen Information Security against rising Cyber threats.
• Developed & Managed a GRC solution roadmap for Confidential internal & external entities.
• Authored a ‘Playbook’ for hosting systems in Cloud partnering with Legal, Business\IT. This was published as Governance for vendor hosted solutions.
• Lead Information Governance Management (IGM) function for IT, Digital, Security and Business, partnering to build foundation that protect organization’s assets.
• Provide IGM advice & expertise to contribute to business progress and change to enhance security via controls, CAPA, risk identification, mitigation for compliance.
• Rollout IGM activities according to the Global IGM strategy in alignment with the IT Leadership Team and relevant business stakeholders (e.g. QA, Legal, Finance, etc.).
• Enabler for innovation and innovative technology solutions to increase value proposition towards business growth, while weighing off the risks.
• Championed GRP (Governance, Risk & Process) & Compliance Center of Excellence.
• Performed RM&C activities for audit readiness, received ‘4/4 - A’ GOOD rating.
• Developed the “Audit Readiness Program” & created Audit preparation kits.
• First line of defense for Business partners providing compliance & regulatory direction.
• Second line of defense for Internal Audits and External agencies (Big 4, FDA, SEC).
• Partnered with Vendor Compliance Assessment Services VCAS team for Vendor assessment of Processes, Data storage, PI, EU data, DMZ, SoX for Hosting and Managed Services.
• Launched Internal Treasury Thomson Reuters, SunGard. 5 successful audits.
• Manage a team of IT Security professionals, review deliverables, resource planning, skills development, and foster a high-performance culture. 68 Compliance reports.
• Author* Confidentiality, Integrity, Availability of Assets as Compliance As Risk Enterprise.
• Performed Gap Analysis of SoX systems and created a remediation SOP.
• Reduced costs through strategic internal audit outsourcing and co-sourcing.
• Familiarity with GRC platforms Archer, BWise, Metric Stream.
• Confirmed remediation plan with BPOs and ensure agreement with milestone dates.
• Ensured weaknesses are corrected before date of the assertion and attestation.
• Confirmed progress, follow up with sites to confirm that the issue has been remediated.
• Ensured weaknesses are corrected before date of the assertion and attestation.
• Monitored Adverse events for Corrective Action \Preventive Action for remediation.
• Presented to BPO/Finance Director clearly explain the purpose and use of Shadow, Clearing and Suspense accounts.
• Control assessments & Testing for Periodic review for Enterprise Systems.
• Devised & piloted HPQC ALM in F&BO-HR BT for e-sig as Enterprise testing model.
• Mobilized cross-functional business resources. Successful Merger of Bank Entities.
• Built ITGC framework for assets Hardware\Software\Data on time within budget.
• Reduced deficiencies\service requests from 42% to 18% via QMS (Quality tools).
• Control assessments & Testing for Periodic review for Enterprise Systems.
• Partnered to build Accord(Access) Aveksa4.2.3 for User Access governance
• Designed Control Design effectiveness, Operating effectiveness & SOPs.

Strategy & Innovation Lead, CE COE, Global Commercial

Confidential

Responsibilities:

• Developed Governance framework by influencing Sr. Leadership ensuring adherence to global policies & regulations on congress and convention management.
• Authored a Road Map for congress\convention with various stakeholders.
• Monitored & Reported HCP data to avoid compliance risk.
• Partnered with PMO for project delivery. Assisted in project timeline forecasting, scope control, and budget management. Managed contractors.
• Reviewed and participated in quality metrics criterion for continuous improvement.
• Championed and streamlined SDLC & Agile methodology for FLEX program.
• Maintained & delivered a portfolio of 2 BU with 16 projects by harmonizing processes.
• Volunteered and reviewed Change Management SOPs. Quality of RFCs improved.
• Drafted & presented a framework for SOPs and Job Aids for strategy & SDLC.
• Led a global team of 30+, developed metrics for assessing SoX gaps and trends.
• Established the mantra “We got your back” as a Quality Business Partner.
• Trained (Business, BT, Audit, Vendors, Clients, & Shared Services) for best practices.
• Coached & Mentored BT & Business partners ensuring One BT-1BT partner focus.
• Assisted with SOX 302 quarterly control certification surveys of process owners and process managers with Embedded Self Assessments for 60+ applications.
• Identified opportunities in ‘Lessons learned’, implemented in change management.

Business Systems Lead

Confidential

Responsibilities:

• Spearheaded implementation in LATAM & AFME regions covering at least 28 markets.
• Managed and lead 11 cross functional projects. Delivered on time & within budget.
• Conducted training & Managed On shore & Off Shore teams remote\onsite up to 30.
• Partnered with country BU leads. Manufacturing discrepancies reduced by at least 15%.
• Led team (5) for security risk Gap Analysis for 75 systems from pool of 1500 +.
• Achieved compliance for over 120 remediated high\ medium risk systems with 7 PMs.
• Led team of 4 & created standard Part 11 standards increasing business efficiency.
• Managed and validated GLP & GCP regulated information systems(Ri\Di\Ei.)
• Led the retirement and decommissioning effort at an enterprise level with PMO.

Confidential

Business Analyst

Responsibilities:

• Developed list of commercial banks\mortgage products for trading up to $64 million.
• Performed System Analysis & Design for Mortgage & Web based-MERS registrations.