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Compliance Manager Resume

SUMMARY:

  • A proven Senior Project Manager/ Service Delivery Manager & Systems Integration Specialist with over 18 years of experience coupled with strong technology leadership and expertise.
  • A customer focused Manager with strong interpersonal skills and enthusiastic demeanor.
  • Six Sigma Total Quality Management (TQM) professional assurance and best practices.
  • Dedicated to delivering a positive internal and external client experience.
  • Pharmaceutical, Medicine, Education, Government, Aerospace, Telecommunications, Energy, Software Technology.

TECHNICAL SKILLS:

Subject Matter Expert in project management, application development supporting - SDLC, Agile methodology, Agile Scrum Master, Product Owner, Microsoft Project (SME), SIP, Confluence, Version One, TDM, SaS Business Analytics and Business Intelligence, XtremePM, SAP, Clarity, HP Quality Center/ HP ALM, IBM Rational, CMDB Service Now, Cognos,, Visio, Metrics dashboard, change management subject matter expert leveraging CMMI methodology and best practices, recognized for presentation skills to senior management. PMP, Program Management Professional from the Department of Defense. IBM Disaster Recovery/ Business Continuity Planning Subject Matter Expert.SDLC- Agile Subject Matter Expert for application development.Recognized as a team builder, integration troubleshooting expert - providing creative client solutions.

PROFESSIONAL EXPERIENCE:

Confidential

Compliance Manager

Responsibilities:

  • Migration and system integrator for (3) Pharmaceutical Data Centers. Merging two different pharmaceutical companies, legacy Confidential with legacy Baxalta.
  • In charge of migration of all corporate systems for transition and transformation.
  • Formulate and lead the master qualification plan for datacenter pharmaceutical systems and applications and ensure successful migration with minimal defect and disruption to end users.
  • Ensure the project teams and staff members meet Confidential and global health requirements; CFR 21 Part 11, EU Annex 11, HIPAA and Confidential .
  • Defend the project teams undergoing audit by both internal and external auditors and respond to any observations and or citations with appropriate response.
  • Initiate and direct any corrective and preventive actions (CAPA) as required to completion.
  • Audit Vender management for compliance.
  • Conduct installation qualifications, operational qualifications and performance qualifications on equipment and facilities along with validating critical medical, financial and manufacturing systems with supporting documentation. Lead issue resolution and risk containment.

Confidential

Project Manager / Operations Manager

Responsibilities:

  • Assist the Confidential ’s data science team in developing statistical algorithms that help clinicians, physicians and nurses predict (foresee) potential health problems with patients (based on certain symptoms that the patients may have) and deploy a predictive model via machine learning and artificial intelligence. The team generates alerts for heart failure, mechanical breathing (vent weaning) and other advanced scientific modeling.
  • Work with the Chief of Quality for all hospitals in the health system to lead lean six sigma black belt projects in an agile approach for hospital improvements in regard to decreasing mortality rates, reduce infection and improve patient satisfaction.
  • Lead quality medical six sigma black belt projects at clinical level for training to cardiac surgery teams, attendees and improve physician and nursing best practices to promote higher levels of patient care.
  • Assist the Chief Data Scientist with implementation, planning scheduling and vender management. Serve the team as Scrum Master, facilitator, manager of platform builds, system security and execution of projects and programs. Fully integrate systems with EPIC and ICD9, 10 billing along with other related systems.
  • Mentor and train project managers, six sigma black belts, PhD’s, Physicians and department leads in agile methodologies and process improvement. Trainer in MS Project, Agile SAFe subject matter expert.
  • Build and deploy the production system architecture to maximize throughput, remove bottlenecks when possible and support highly advanced applications for predictive big data mining analysis. Support the Data Science Team and Senior Hospital Leadership.

Confidential

Project Manager/ Validation

Responsibilities:

  • PM and Lead for Confidential Transition and Transformation projects integrating 21 new systems into the existing and future architectural design. The new tools integrate with - software, middleware, application development and infrastructure. Responsibilities include testing for intended use, conducting risk assessments utilizing GAMP 5 guidelines and best practices to ensure deliverables meet Confidential qualification and requirements. Scrum master & product owner for testing.
  • Cut the operational queue process & workload in half (50%) by instituting lean sigma best practices, training and fostering strong vendor relationships while developing high value metrics to serve as control points.
  • Performed numerous qualifications/ validations and system integration on applications, SAP, various databases, software tools, datacenters, servers, and SAN devices to specification.
  • QA Test Lead for Confidential SAP Qualification/ Validation (over 100) and Oracle12C to include script development, testing, work instructions and SOP deliverables. HPALM Platform SME.
  • Re-wrote business process, SOP's and work instructions to meet contractual deliverables on time and on budget.

Confidential

Senior Project Manager

Responsibilities:

  • Data center management for physical infrastructure to include, UVN, OC-192/48, Gig E, operations, rack elevation, Confidential, cabling, wiring, firewalls, telecommunications, SAN and complete network topology.
  • Next generation datacenter build for Confidential . Cisco Unified Computing system. 11.6 million dollar data center rebuild. Virtualization and container/pod builds for the entire enterprise.
  • Window 7 Deployment to the entire infrastructure worldwide. Desktop/App/dev certification & servers.
  • Agile scrum master.
  • Develop, test and run disaster recovery exercises and business continuity plans for the New York Post.
  • Fork lift technical refresh for (7) Individual newspaper companies owned subsidiaries of Confidential . Full disaster recovery planning. Ultra-low latency for network infrastructure and financial reporting /transactions. Design and deploy VoIP and other leading technologies to major publications within the Confidential corporate infrastructure.
  • Corporate data center migrations and decommission the centers and legacy equipment in compliance with Sarbanes Oxley standards & PCI.

Confidential

Project Manager - Quality Manager/Change Control Manager

Responsibilities:

  • Manage 28 work streams comprised of testers, developers integrators and numerous vendors for Confidential - Confidential Integration.
  • Provide joint oversight, quality management and metrics dashboard to CTO's for both organizations.
  • Subject matter expert for IBM Rational Clearquest & HP Quality Center. Administrator, Quality Analyst and Trainer to over 1000 developers, testers and project managers.
  • Identify deviation to requirements for all banking and investment functionality from ATM withdrawals and online banking to mortgage and investment buy/sell placements down to branch level from penny stock to 54 billion dollar money movement.
  • Provide oversight to all integration points for all systems to include IVR (Interactive Voice Response), call centers, joint mainframe records integration, statements, investments and banking functions.
  • Facilitate Change Control Board Committee ( Confidential ) meetings to accept or reject proposed changes to original functional /business requirements. Assist teams prior to presentation to Confidential ensuring regulatory standards are met and banking process compliance is followed.

Confidential, Princeton, NJ

Senior Quality Systems Manager-/Project Manager

Responsibilities:

  • Conduct and oversee project, metrics and strategic vision for the College Board & the Senior ETS Executive team on over 50 million test administrations per year. SAT development, scoring and reporting to 5400 colleges & universities globally regarding quality performance indicators and reverse engineering efforts.
  • Deploy a Quality Management System to the entire enterprise from RFP to Operational Readiness. My responsibilities include: Development Lead for 8 applications, Infrastructure IPM, Overall Project Management, Vendor Management, Training, Documentation and Change Management.
  • Project manage, programs and portfolio’s for Failure Mode Effect Analysis (FMEA) and over 100 reverse engineering activities for the purpose of process improvements and to deploy product enhancements.
  • Validate and certify data quality for 42 programs in -flight. Quality Assurance.
  • Document change requests, control risk management and maintain scope.
  • Lead multiple process improvements in documentation, process and knowledge transfer.
  • Reengineer systems architecture and placed 20% of all programs into automated production within first three months of assignment. Projected 20%+ cost savings in manpower while decreasing production costs.
  • Participate in Six Sigma Black Belt DoE (Design of Experiment) for Scan Control producing Control Charts and ANOVA (Analysis of Variance) resulting in patent filing. Agile product owner.

Confidential, Princeton, NJ

Senior Project Manager

Responsibilities:

  • Data Center Optimization Project for power and cooling one of the Confidential ’s “top five” projects for the year. Includes complete Confidential forklift upgrade for entire infrastructure optimizing data center environmental systems, increasing capacity and engineering out to 2010 for all lines of business. Project was delivered on time and under budget.
  • VoIP recording project for Factiva and Confidential globally decreasing cost and increasing customer service performance.
  • Confidential system integration with Factiva globally.

Confidential, King of Prussia, PA

Senior Project Manager

Responsibilities:

  • Instituted several quality gateway checkpoints on behalf of Confidential e.g. end-to-end testing and full load capacity testing which saved the entire project and enabled the application to perform as intended.
  • Established Full Project Plan.
  • Agile Product Owner.
  • Entire Project Schedule for all 3 Phases and full system cycle.
  • License entitlement and software asset management for 130,000 users in 63 countries and written in 17 languages.
  • Negotiate with vendor development team milestone dates and customizations.

Confidential, Trenton, NJ

Project Manager

Responsibilities:

  • Established PMO office and led technical team of 18.
  • Agile product owner & practitioner.
  • Ensured Independent Verification and Validation (IV&V) through audit compliance.
  • Developed testing criteria, communications plan and governance of project path in accordance with Project Management Institute (PMI) methodology and IEEE standards, ISO 9001.

Confidential, Cherry Hill, NJ

Project Manager, Business Management-, Engineering, Software Development, IT Services

Responsibilities:

  • Confidential Public Service. Construction, power, instrumentation and controls project team to rebuild datacenter and control room. Agile product owner.
  • Consulting Project Management Engineer for Eastern University data center construction.
  • Confidential Power Systems, instrumentation and control installation project team.
  • Project Leader for Confidential (Japanese telecommunications carrier) complete software development package utilizing CMMI methodology from inception to production for operations, sales and marketing written in dual languages (Japanese and English). Led business requirement team, functional team and financial team to project completion. Project was finished below budget due to resource leveling and cost containment.

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