Ira A. Starr

** ******* *****, ********* *****, New York, 10567 • Home: 914-***-**** • Cell: 914-***-**** • E-mail: acr4wq@r.postjobfree.com

» Career Profile

Highly experienced information technologies executive within the pharmaceutical/healthcare and finance sectors.

Skilled in regulatory compliance, validation, equipment and instrument qualification, auditing, project and resource management, business analysis, systems analysis, design, development, implementation, and support.

Significant experience in the validation of computerized systems and SDLC methodology.

Demonstrated leader of small and large teams with expertise in managing technical projects, building relationships, communicating solution strategy and product offerings, and providing technical expertise, support, and training to customers.

» Skills

Computerized Systems Validation, Equipment/Instrument Qualification, and Compliance Auditing

Gap analyses, risk assessments, risk-based validation methodologies, and remediation plans

Validation plans and summary reports

User/Functional requirement specifications

Configuration and design specifications

Traceability matrices

IQ/OQ/PQ protocols and summary reports

Test protocol execution and deviation resolution

Change Control

Manufacturing and laboratory equipment/instrument assessments and writing qualification protocols

Temperature/Humidity mapping (Kaye Validator 2000, Vaisala Data Loggers)

Policies and procedures

System documentation and training manuals

User and technical training

FDA inspections, ISO quality audits, IT SOX reporting controls and auditing, internal compliance audits

GCP/GMP vendor/CRO audits

21 CFR Part 11, and EU Annex 11 compliance

Well versed in cGMP, QSR, GCP regulations and GAMP5

Project Management

Business case development

RFI/RFP development and analysis

Vendor selection and management

Contracts and agreements

Project plan development and maintenance

Resource planning and management

Budgeting

Project management tools (Microsoft

Project, Visio, Office)

» Work Experience

MannKind Corporation, Danbury, Connecticut - (July 2006 to September 2015)

Associate Director, Systems Assurance, February 2011 to September 2015

Provided effective interpretation, guidance, and recommendations for changes to systems and processes in the areas of compliance, regulatory requirements, and continuous process improvements. Performed and led internal and external audits and assessed compliance in accordance with regulatory requirements and internal procedures.

Performed qualification and commissioning activities for clinical and commercial manufacturing/laboratory equipment and instruments, and temperature/humidity mapping qualification for freezers (regular and cryo), refrigerators, incubators, stability chambers, autoclaves, and facility storage rooms.

Computerized Systems Validation Responsibilities

Provided company-wide strategy, direction, oversight and guidance in establishing software quality assurance and compliance practices through the development and implementation of processes, policies, and procedures and ensured quality standards were established and maintained for all phases of the computerized system life cycle.

Provided QA oversight (reviews/approvals) for all IT GxP computerized system validation activities and documentation including: Validation Risk Assessments, Validation Plans, User/Functional Requirement Specifications, Configuration and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance Testing, Traceability Matrices, Validation Summary Reports, SOPs, and Change Controls.

Managed the IT/Quality Sarbanes-Oxley audit program to identify weaknesses and deficiencies in IT financial reporting controls while working closely with Internal Audit and the company’s external auditor Deloitte.

Equipment Qualification and Calibration Responsibilities

Drafted and executed qualification protocols for: Temperature/humidity mapping of commercial/clinical manufacturing chambers and QC and Pharmaceutical Analytics (PA) lab equipment, Sartorius filter integrity testers, RODI purified water systems, and other commercial/clinical equipment and systems.

Performed periodic GMP reviews of commercial/clinical equipment and systems and developed impact assessments when required.

Managed the equipment/instrument calibration program for the QC and PA departments.

Auditing Responsibilities

Managed the preparation, coordination, and execution of internal IT audits and external GMP vendor questionnaire audits in accordance with regulatory requirements and internal procedures.

Performed GCP vendor/CRO audits, as lead auditor, or in coordination with other auditors, and ensured follow-up and corrective action planning. Wrote audit reports for internal management and vendor review and managed closure on all compliance findings, recommendations, and corrective action plans.

Participated in PAI/FDA/ISO/SOX readiness activities/inspections. Subject matter expert for Quality Compliance Audit program with specific focus on computerized systems used for GxP internal and vendor specific applications.

Participated in quality control review of NDA submission documentation.

Associate Director, IT Systems Assurance, November 2008 to February 2011 (Promoted Position)

Senior Manager, Computer Systems Validation, July 2006 to November 2008

Responsible for the management of computerized system validation activities related to the validation of a biopharmaceutical manufacturing facility suitable for FDA drug approval.

Managed full-time validation professionals and provided strategic direction, leadership, analysis, guidance and training to project teams for achievement of superior quality software implementations.

Directed validation teams in developing and enhancing a risk-based, life cycle management process and document templates used at MannKind to speed the validation process for GxP impacted applications.

Managed and actively participated in a company-wide retrospective validation of lab instruments, computerized clinical manufacturing equipment, regulated computerized systems, and software and hardware components comprising the IT network infrastructure and data centers.

Managed resources and participated in ongoing efforts to validate MannKind’s Microsoft Dynamics GP ERP system ensuring compliance to cGMP and 21 CFR Part 11 FDA regulations.

Developed, administered, and ensured compliance of MannKind’s Sarbanes-Oxley IT financial reporting controls program.

Developed and distributed policies and procedures to ensure the consistent application of computer validation principles and tactics across the organization.

Coordinated all IT internal and external auditing requests (i.e., PAI/FDA, ISO, SOX, Corporate) to confirm compliance to regulations, company/site policies, processes, and procedural requirements.

Provided training for company employees on software validation processes/procedures, risk assessments, FDA/SOX regulations and ISO standards.

Bristol-Myers Squibb, New York, NY and Princeton, NJ - (March 1981 to September 2005)

Associate Director, IT/Quality Assurance, ConvaTec Division, September 2004 to September 2005

Responsible for maintaining and overseeing the quality processes and compliance of ConvaTec’s (Bristol-Myers Squibb division) computerized systems subject to the FDA’s 21 CFR Part 11 regulation.

Developed, documented, and implemented IT/QA processes and procedures in providing effective quality methods to ensure the proper intended use and functioning of regulated, computerized systems.

Performed quality compliance reviews and assessments for the installation and validation of computerized systems at Corporate and manufacturing locations.

Associate Director, Applications Development, ConvaTec Division, October 1998 to September 2004

Responsible for applications development and validation of ConvaTec’s computerized systems subject to the FDA’s 21 CFR Part 11 regulation.

Managed an IT team in developing user/functional requirement specifications, validation plans, design specifications, qualification plans and protocols, associated summary reports, and maintained electronic and hardcopy validation documentation.

Validated and ensured 21 CFR Part 11 compliance for systems such as: Complaint and adverse event handling, CAPA, calibration, and enterprise document management.

Developed standard operating procedures and guidelines for ConvaTec’s divisional regulated systems.

Provided guidance on the development of testing strategies and input on systems development activities to ensure that principles of validation were captured and maintained throughout the System Development Life Cycle.

Provided quality compliance reviews and assessments for the installation and validation of computerized systems at manufacturing locations.

Provided training and guidance to application and support personnel on validation and standard operating procedure requirements.

Participated in compliance audits to ensure regulated systems conformed to FDA regulations and company requirements.

Additional responsibilities focused on the development, implementation and ongoing management of ConvaTec’s global CRM initiatives including development of call center, regulatory and validated complaint handling, database marketing, sales, and business analytics applications and solutions.

Managed ConvaTec’s US CRM Development Team in the multinational implementation of PeopleSoft’s CRM Support system.

Managed the design, configuration, testing and implementation of a network infrastructure to support an integrated CRM solution across multiple departments including multinational call centers, Regulatory and Medical Affairs groups, Database Marketing, and e-Business.

Managed the implementation partner external recruiting and staffing process and integrated those resources with the internal project implementation team.

Managed validation, development, code build activities, and documentation to ensure adherence to FDA validation requirements as per 21 CFR Part 11.

Ensured overall management/success across the following project components: Technology and infrastructure, application management, validation, client coordination, procurement, and resource management.

Directed a team in building a sales force automation (SFA) architecture and business operating environment for ConvaTec’s field sales force of 200+ sales reps. Overall architecture included a customized field sales application, laptop PC, and web site built specifically for the field sales force.

Managed the selection of a packaged software solution to meet the primary needs of the field sales force including working with business clients to build and distribute an RFP to SFA vendors.

Managed IT technical teams to procure, configure, test, and distribute IBM laptops to the field sales force, with custom and off-the-shelf applications, and provided support through the Company’s Corporate Help Desk.

Managed IT staff through all phases of development, implementation, ongoing maintenance, and support of an internal field sales web site.

Responsible for the selection and implementation of Avaya’s Conversant Interactive Voice Response system and its integration with ConvaTec’s head office Definity/G3 PBX.

Managed staff in the development and distribution of a comprehensive RFP document, hardware and software vendor selection and implementation, and worked with call center clients and third-party vendors to build self-service and call flow applications.

Associate Director, Infrastructure Applications (Bristol-Myers Squibb Corporate), 1993 to 1998

Responsible for implementing a global, enterprise e-mail system for Bristol-Myers Squibb.

Managed a team of internal division e-mail professionals and external consultants and evaluated the company's distributed e-mail systems and directory services strategy.

Developed an RFP for a global e-mail system solution, and managed the vendor evaluation process and technical team in selecting and implementing an Internet-based mail solution.

Managed and directed a technical team responsible for the design and implementation of Bristol-Myers Squibb’s global electronic mail network linking thousands of e-mail users using disparate mail systems. Managed all aspects of the project from RFP development through implementation and operations of equipment.

Designed and implemented a Macintosh-based flight scheduling system and network for the Corporate Aviation Department.

Designed, coded and implemented Bristol's first mainframe e-mail and groupware system. System was built and enhanced over many years, and became the standard e-mail and groupware application for the Company.

» Education

City University of New York - Queens College

B.A., Computer Science

» Additional Professional Experience

Bristol-Myers Squibb (B-MS)

Associate Director of Office Automation and Executive Support Systems (B-MS)

Manager of the Corporate Information Center (B-M)

Technical Support Specialist (B-M)

Bankers Trust Company, AVP Applications Development, Citibank, N.A., Mgr. Applications Development,

Bache and Company, Programmer/Analyst, E.F. Hutton, Computer Systems and Operations Analyst

» Certifications

ISPE – GAMP5 Methodology

» Application Software Proficiency

TrackWise, Blue Mountain Calibration Manager and Regulatory Asset Manager, Microsoft Dynamics GP ERP, PeopleSoft CRM, Microsoft: Word, Excel, PowerPoint, Visio, Project, Outlook, SharePoint

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