SUMMARY:

• Proactive, seasoned and results - driven senior leader/professional with a broad range of global experience across multiple industries.
• Experienced in life sciences (medical operations, pharmaceuticals, medical devices), consumer and commercial product manufacturing, product marketing/launches and quality/assurance/control, financial/compliance services.
• Strong working knowledge and experience of the pharmaceutical drug development lifecycle and its four clinical phases along with medical device design, manufacturing, service and product rollout and launches, SPC/SQC and Confidential .

KEY STRENGTHS & EXPERTISE:

• Quality/Risk Management
• Quality Assurance & Control
• Strategic to Operational Plans
• Operational Excellence & Research
• Regulatory Compliance
• Project/Program Management
• Systems & Business Development
• Staff Training & Leadership
• Problem Analysis/Resolution
• Process Reengineering
• Operations & Manufacturing Management
• Audit & Analysis
• Product Lifecycle Management
• Validation & Testing
• Predictive Analytics/Machine Learning/DM

EXPERIENCE & NOTABLE CONTRIBUTIONS:

Sr. Program Manager, Management Consultant

Confidential

Responsibilities:

• Provided project/process leadership to a varied group of companies, including planning, quality systems, regulatory and compliance to meet client needs.
• Oversaw all aspects of business requirements development, strategic planning, risk management, business continuity, disaster recovery, medical device and pharmaceutical design and development, assays, product rollouts, product launches, installations, supervision, data mapping and conversion, acceptance testing, end-user training, and documentation.
• Developed, implemented and coordinated product assurance programs preventing defects in new and/or existing products.
• Areas of competencies: analytical, design, problem solving, project/program management, technical skills, customer service, interpersonal skills, change management, quality management and business acumen.

Confidential

Sr. Valdidation Specialist

Responsibilities:

• Provided validation support including requirements, protocol and testing services and documentation to the client’s manufacturing and process facilities.
• Key updates to their technical files and risk management documentation and procedures.

Confidential

Sr. Program Manager

Responsibilities:

• Manager responsible for suggesting and debating alternative methods and procedures for 4 products (infusion pumps, biosimilars and injectables). Developed initial modification of product assurance program to delineate areas of responsibility, personnel requirements and operational procedures. Reviewed technical problems and procedures recommending solutions to problems or changes.
• PM responsible for the unclaimed property audit resolution covering AP, rebates, returns and discounts. Resolution reserves covers over $6.9MM and over 10 years ($6.4MM rebates, $0.5MM AP/others) interfacing with corporate legal, and state-wise external auditors.
• Assisted the US commercial team on a new medical product launch for Dyloject(anesthesia), reviewing stability, efficacy studies and SRD assembled (dossier, safety, HACCP, CT overview), second manufacturing sourcing and the Confidential and Confidential submission documentation
• Conducted a business continuity review/assessment providing a framework of policies, strategies and programs supporting alignment, disruption accountabilities, forecast inventory levels, expectations, risk management, customer relations and delivery. Assisted R&D teams with updates to the medical device procedures covering 8D segments based upon CFR 820.

Confidential

Sr. Compliance Manager

Responsibilities:

• Provided Compliance Program/Project Management supporting their US commercial quality division. Conducted a feasibility and gap assessment of current procedures, instructions and records. Implemented the latest 7 pillar Confidential methodology from ASQ and Confidential supporting updates to 21CFR 820, ISO 14971, 14001, 13485:2015 and IEC. 62304). Updated 25 policies, procedures, protocols, work instructions, work streams, risk and records management.
• Managed and lead the execution of the US commercial quality audit reviews, including Project management and resource planning. Assessed the risk-based determinations on audit scope along with the design and execution of test plans to validate controls and service standards. Oversaw the findings remediation.
• Managed 8 RA/QA auditors for their annual reviews, requests and schedules covering process, service, third party suppliers and field action departments in US commercial.
• Oversight Mgr for Manufacturing Production (Facilities/PR, MV and RM):
• Provided timely assessment and closure of batch and material hold events, lot disposition pending issues, activities and standard lead times metrics.
• Ensured that products were manufactured in compliance with regulatory and GMP guidelines
• Reviewed Manufacturing Production Records
• Reviewed selected batch related documents and package records that were part of a Final Product lot disposition package
• Performed quality investigations of manufacturing Deviations, GMP and Quality System issues, non-conforming materials, and CAPA, defect preventions using SPC/SQC principles.
• Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues
• Reviewed the disposition of disposable raw materials and components associated with GMP use
• Reviewed equipment and facility technical and investigation reports
• Provided QA management to contractors assuring products met specifications, testing, registrations and self-audit results.
• Managed and led the divisional NC/ER/CAPA/Deviation review board through weekly meetings with senior directors and functional departmental manager. Output from meetings resulted in reviews, assessments, inventory management, recommendations and compliance documentation. Resulted in eliminating 15 compliance audit findings within 2.5 months. Coverage supported all US, Canadian, Mexican and LATAM sites. Systems used: Trackwise, SharePoint & Cognos.
• Primary approver of incident, deviation, exception investigations, assessments and effectiveness reports. Provided guidance and technical expertise to site staff in investigation methodologies, root cause analysis, continuous improvement, technical writing and risk management. Also provided procedures to support hazard analysis and critical control methods on 15 products and services.
• Developed the service validation process/procedures for product tooling and testing. Also developed quarantine procedures for device returns associated with the Ebola outbreak for the infusion pump assemblies.

Confidential

Sr. Program Manager

Responsibilities:

• Senior Manager responsible for the global development and implementation of a product, facility, registrations, project management and the global regulatory life cycle management program, including the system validation, data migration, training and roll out. Also reviewed and updated their change management process associated with facilities, quality assurance and regulatory compliance.
• Provided Program/Project Management development, validation, data migration for three global regulatory affairs computer systems (Samarind/RegTrack/RIM, A4L, FirstDoc/Documentum, DOORS and PLM).
• Supported the RA director in development and deployment of QA/RA, divisional Confidential policies/procedures for Confidential, Computer systems and CMC. Implementing new updates for risk and compliance regulations (ISO 14971, 13485, 27001 and CFR 820). Member of the R&D team on new generation AutoP medical device, assisted in the design transfer from R&D into operations/manufacturing.

Confidential

Program/Project Manager

Responsibilities:

• Provided program/project Management for the medical products division on performance, risk management, budgets, engineering concepts (FIDAP, SolidWorks), program administration(profitability, revenue streams, margins), financial management and issue resolution to key international multi-disciplined/functional groups (R&D, Technology, Manufacturing, Specialty Pharma, Regulatory, Medical, Purchasing, Supply Chain, Quality, marketing and clinical). Interacted with regulatory agencies for submission plans and manufacturing specification requirements.
• Interacted with manufacturing environment for design and existing product lines.
• Resulted in updates to procedures and core supplier specifications along with production batch records/serialization.
• Core developer and PM for the DVU injection molded assembly. Responsible for the molds, supplier negotiation, budgets and engineering design of the unit. During same time, design and product PM for another medical product (butterfly subQ needle set). Delivered this product in 6 months into marketing and first day launch.
• Lead manager associated with the Configuration Management Process (i.e. CMII). Worked with external consulting practice for CMII covering the 9 segments of device design, management and documentation (e.g. Design inputs, outputs, transfer, DHF, DMF, PFMEA, PPFMEA, HACCP). Also managed the design for quality controls for pilot facility manufacturing plant metrics and procedures (JDE/ERP, PALMS/MRP, DOORS, SCARPI). Coordinated cross functional new product launch planning, planning for product development and requirements.
• Monitored the execution of project plans and held all stakeholders accountable for timely delivery of their commitments.
• Conducted risk and process development assessment and started the CMMI, PLM and CMII implementation resulting updates to 15 systems and new workflow handlers for changes, CAPAs, issue management and resolution. Updated the divisional Confidential procedures to reflect new changes for packaging/labeling, lab procedures, product lifecycle, inventory controls, mgmt. controls, facilities, equipment, computer systems, material handling, production and process controls. These changes eliminated potential 483 observations from 4 audits.

Confidential

Compliance and Security Manager

Responsibilities:

• Trained the PLM team on quality Confidential and compliance SOPs and validation standards supporting lifecycle, computer systems, management control and process/production. This eliminated 2 corporate audit findings by Confidential and Confidential .

Confidential

Sr. Program Manager/Assoc. Director

Responsibilities:

• Provided project/program management to Global Regulatory Affairs/Affiliate and Area strategy division.
• Responsible for consolidating the division financial/budgets/forecasts. Set up the strategy for the Confidential product rollout of Humira along with the clinical testing programs.
• Developed and implemented targeted process improvements, as well as strategic-level transformations using Value Stream and Velocity Management models and mappings.
• Updated and trained staff on Confidential procedures and policies associated with mgmt. controls, lifecycle mgmt., computer systems, production/process controls and label mgmt. This simplified the Confidential separation.
• Assigned as one of the department’s representatives for the upcoming company-wide split and separation activities ( Confidential .

Confidential

Sr. Program Manager

Responsibilities:

• Assisted in developing SOPs for QA/QC/ Confidential associated with drug/device product supply, protocol design, manufacturing processes, engineering, packaging, labeling, shipments, sterilization, freezer validations, receiving/returns and study designs/filings.
• Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues
• Reviewed the disposition of disposable raw materials and components associated with GMP use
• Provided complete validation protocols, test procedures and documentation for Confidential following GAMP5 guidelines.

Confidential

Technical project/program manager/ Senior Business Architect

Responsibilities:

• Coordinated customer requirements, project management, change/risk/issue management, data center integrations, compliance documentation and governance.
• Co-Lead architect on developing the next generation application framework using common core technology, Python and cloud computing.
• Contributed to ongoing business monitoring and optimization activities, provided advisory services during the development of new businesses and systems. Performed regulatory and audit reviews.

Confidential

Sr. Project Manager

Responsibilities:

• Provided temporary validation and project management support to the IT quality systems group and perform 2 SOX assessments for process compliance.
• Provided reviews and data migrations using data mining techniques for cleansing, categorizations, classifications and aggregations.
• Resulted in a new updated data warehouse structure facilitating conversion to newer systems.

Confidential

Management Consultant

Responsibilities:

• Provided quality and regulatory support for audits, clean room and manufacturing procedures (example chemical handling, aseptic methods).
• Developed updated procedures to cover preventative maintenance programs associated with the line equipment, personnel and material handling.
• Responsible for the third party contract manufacturing requirements and product scheduling along with audits associated with Zimmer, Stryker, J&J, and Paragon.
• Provided timely assessment and closure of batch and material hold events, lot disposition pending issues, activities and standard lead times metrics.
• Ensured that products were manufactured in compliance with regulatory and GMP guidelines
• Reviewed Manufacturing Production Records
• Reviewed selected batch related documents and package records that were part of a Final Product lot disposition package
• Performed quality investigations of manufacturing Deviations, GMP and Quality System issues, non-conforming materials, and CAPA
• Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues
• Reviewed the disposition of disposable raw materials and components associated with GMP use
• Reviewed equipment and facility technical and investigation reports
• Reviewed defective products & goods for returns and/or recalls. Reviewed aborted batch records for trends and systemic issues.
• Reviewed the installation and removal of new line equipment.
• Updated their purchaser supplier and quality agreements to conform to current ISO and Confidential guidelines.

Confidential

Principal Program Manager

Responsibilities:

• Setup, planned and executed over 15 continuous improvement programs using lean, TOC and 6 sigma frameworks supporting project/program management, supplier / vendor management auditing and assessments.
• Directed outside consulting efforts for business monitoring (KPI/CI/ITSM/CMMI) and optimization activities. Reviewed the process for identifying business risks, understanding organizational changes. Led projects aimed at optimizing business processes and control activities. Performed regulatory and compliance audits and reviews (SOX, HIPAA, ITIL).
• Comanaged the SAP R3 to R4 update transition. Developed the feasibility assessment, program budget, charter, plan, and WBS.

Confidential

Principal Validation Manager

Responsibilities:

• Developed requirements and initial deployment and validation of their Customer Relationship Management system.
• Applications supported were call center operations, demand processing, inventory management, complaint handling and repair management and control.
• Performed their validation documentation following GAMP and reviewed/approved the testing of their Confidential CRM systems and applications.
• Company requested to update the validation 4 years later.

Confidential

IT Program manager

Responsibilities:

• Developed the feasibility analysis/proposal, the project plan, requirements for their specialty manufacturing and products division.
• User and functional requirements were developed for demand processing, inventory management, warehouse management, order management, web access, Materials Management, accounts payable, purchasing, accounts receivable financials, repair depot and rental asset management. Project increased visibility of the parts and manufacturing division providing an increased ROI and ROA of 24%. Managed a team of 6 direct analysts and 2 consulting organizations. Utilized the Agile FDD/RUP methodology.

Confidential

Sr. Program Manager

Responsibilities:

• Managed their worldwide PMO office for their Remediation Process/Program of their legacy applications, tools and system services to meet Confidential requirements. Tools used DOORS, Oracle, SAS and ClinTrace.
• Assisted in updating Confidential 's internal audit program and new Quality Management System.
• Components reflected all 7 quality pillars emphasizing computer systems, mgmt. controls, and lifecycle management.
• Developed a rubric to aid in finding the appropriate procedure based on keywords and tags. This reduced lookup times by 75%.