Secure a position where my proven 15+ years of QA / Compliance / Technical leadership experience in the FDA regulated industry can be utilized and grow.
- 10+ years project management experience, responsible for the implementation of laboratory, manufacturing and software projects, many concurrent.
- Responsible for developing and managing newly created Regional Data Integrity / Data Management / Data Governace team and department.
- Follow ALCOA+ to ensure data security and meets FDA requirements.
- Created a data integrity master program plan to evaluate (checklists) and implement gap closures for existing Laboratory, Production and software systems and procedures (1,000+). Program plan included the mitigation and remediation of systems by upgrading / replacement of systems and continuous improvement to ensure data integrity was maintained throughout the data life cycle.
- Successfully managed multiple projects to completion, some projects had lateral or dependent timelines and were implemented simultaneously.
- Conducted internal / external compliance assessments / audits (21 CFR Part 11, 210, 211) on laboratory, production and quality computerized systems to evaluate compliance to data integrity guidance. Assessed systems’ audit trail, data backup capacity, data / system security, login / segregation of duties, systems SOPs, Change Request, Validation Packages, etc. Categorized gaps based on risk, data criticality, etc
- Conducted Risk Assessments to determine potential failures, evaluated their criticality and proposed risk reduction measures. Re - evaluated the associated risk after remediation efforts were implemented.
- Implemented compliant software and / or procedural fixes to eliminate gaps found during assessments / audits.
- Over 15+ years experience (Project Management / Team Member) validating computerized systems, software and equipment in the FDA regulated industries.
- Successfully lead both onshore and offshore teams in closing technical and procedural FDA and business requirements gaps.
- Experienced with GAMP 5, quality system periodic review, data review, document controls, quality assurance, change management, audit observation, CAPA and deviation management, root cause analysis, revalidation, and data integrity assessments.
Software Applications: Microsoft Word, Excel, PowerPoint, Access, Project, Outlook, Lotus Notes, TrackWise, ExcelSafe, Argus Safety 4.1, Oracle AERS, TrackWise, Blue Mountain, Manager 2000, Front Page, PageMaker, Frame Maker, Adobe, Visio 5.0, SAP, Netscape, ACT, Protoshare, SharePoint, Rectify, Documentum (PDoc), Test Manager, Test Director, ARIS, HP Quality Center
VALIDATED SOFTWARE AND EQUIPMENT:
- BMRAM ePDM / Solid Works
- SAP ECC 6.0 (Validation Lead) / Serialization
- Oracle AERS / Clinical
- Argus Safety System
- Microsoft Access Database
- BMRAM / CalMan
- Tivoli Storage Mgr
- Quality Doc. Software
- Visual Manufacturing/Quality
- MasterControl v9 Document Management System
- Livelink Enterprise Content Management v. 9.7 System
- Agile Quality Management System
- Extedo eCTDmanager v.2.5.1 System (ECM)
- Test Director
- Sage X3 ERP
- Cardiac Remote Monitoring System
- Empower 2 & 3
- BET / Endoscan
- Mocon OxygenUPLC / HPLC
- UV Vis
- Baker SterilGARD III Advance Biological Safety Cabinet
- FACSCalibur Flow Cytometer
- CO2 Incubator
- MD Micro Plate Reader
- Dissolution Bath
- Water Purification Systems
- X-Ray Imaging Software
- Watson / LabVantage LIMS
- Integration Manager
- Filter Integrity Tester
- Glove Integrity Tester
- SKAN Isolator
Confidential, Wilson, NC
Sr. Computer System Validation Engineer / Data Integrity Lead
- Responsible for forming and managing Regional North America Data Integrity, Data Management, Data Governance Department and team (5 headcount) within the Quality Assurance organization.
- Authored master data integrity program plan to assess and evaluate 1000+ networked / standalone systems and procedures (instruments, equipment & software) with data integrity gaps. Prioritized systems and implemented mitigation / remediation activities to close gaps.
- Lead multiple Regional (Laboratory, Production and Software) remediation projects simultaneously; designed and implemented a backup and restore network for standalone systems (instrument, equipment & software) - 30M+.
- The North America Regional Data Integrity practices and strategies were used to support sites outside of North America in becoming compliant.
- Created SOPs (GEMBA Walk / Internal Audit, Audit Trail Review (Dept. and QA), Critical / Non-Critical Data Risk Assessment, etc.).
- Created / updated cross-functional SOPs (CSV Program Plan SOPs, Investigation / Deviation SOPs, etc.)
- Authored and executed Risk Assessments / Checklists used to conduct hands-on assessments of Regional systems, identified gaps, created CAPAs and collaborated with Stakeholders to define a gap closure plan.
- Responsible for leading and executing a Regionally consistent, harmonized, sustainable and effective Data Integrity Program that complies with regulatory requirements and company established requirements.
- Responsible for ensuring systems across all Regional sites comply with data life cycle requirements from initial data creation/recording to archival and decommissioning. This includes, but is not limited to, data management (e.g., data creation, data processing, re-processing, review, reporting), data security, data traceability process mapping, data backup/restore, electronic signature/electronic record linking and data audit trails.
- Responsible for leading, reviewing and approving data integrity assessments across all Regional sites of new and existing systems including, but not limited to, manufacturing and laboratory systems to ensure compliance with regulatory requirements and company established requirements for data integrity.
- Responsible for leading, reviewing and approving data integrity periodic reviews and performing risk monitoring of implemented systems across all Regional sites to ensure continued compliance.
- Responsible for defining, assembling and communicating data integrity metrics that yield on-going process improvements and optimization across all Regional sites.
- Responsible for leading, reviewing and approving mitigation and remediation strategies across all Regional sites when data integrity gaps are identified.
- Responsible for leading, reviewing and approving investigations across all Regional sites and implementing corrective/preventative actions associated with data integrity events.
- Responsible for ensuring data integrity processes for automated systems across all Regional sites are designed to align with computerized system development life cycle (SDLC) methodologies to ensure computerized systems meet regulatory requirements, company requirements and align with industry standards. In this respect, this role is also responsible for assisting with strengthening and modernizing existing computerized SDLC methodologies to align with data integrity processes.
- Responsible for leading, reviewing and QA approving SDLC deliverables (Change Controls, Validation Plans, Specifications, Protocols, SOPs, etc.) associated with data integrity compliance projects across all Regional sites.
- Responsible for performing continuous improvement of the Regional Data Integrity Program ensuring the program is maintained current with industry standards and support key company initiatives.
- Responsible for leading on data integrity and associated processes.
- Maintains awareness of data integrity regulatory actions (FDA 483s and Warning Letters), current regulatory trends and their impact on existing systems and recommends internal process improvements.
- Provides leadership in interpreting regulations and guidelines associated with data integrity to ensure continued compliance of the Regional Data Integrity Program.
- Seeks out and recommends to management opportunities for increased data integrity program efficiencies and operational improvement through modifications to current systems, implementation of new systems and more efficient use of established systems.
- Fosters collaborative and cohesive working relationships with direct reports and all organizations to achieve company initiatives.
- Responsible for conducting performance appraisals and developing the skillset of the data integrity team.
Sr. Computer System Validation Engineer / Data Integrity Lead
- Wore multiple hats responsible for completing validation processes and leading validation teams and reporting.
- Data Integrity Lead - Collaborate with Regional Data Integrity Team to deploy a cohesive Data Integrity initiative.
- Closed site’s internal Data Integrity Gap Assessment CAPAs (Chemistry, Micro, Manufacturing, IT, etc.), authored Data Integrity Site Master Plan, coordinated site’s 3rd Party Gap Assessment / Remediation Plan, coordinated employee data integrity, provide guidance to site to resolve known data integrity issues.
- Audit Team Member for FDA, global and internal audits. Ensure site is in a CSV audit ready state.
- Member of the Confidential Acquisition / Integration Team that was responsible for the acquisition integration activities that merged / migrated / revalidated cGMP systems / procedures from the Becton Dickinson to Confidential ’s systems / domain. (Completed tasks 2 weeks ahead of schedule).
- Responsible and accountable for the site’s development, implementation, execution and maintenance of protocols (IQ/OQ/PQ), validation deliverables (Plan, Design, Requirements, Risk Assessments, Summary Reports, etc.), procedures, practices, strategy, and the validation master plan.
- Provide project management, technical leadership, daily oversight, and validation subject matter expertise needed to manage the entire system life cycle phases, including revalidation and periodic review.
- Lead collaboration between functions to maintain and continually improve an effective cohesive validation approach for computer systems at the local Wilson Site, Corporate and Regional Sites (IL and NY).
- Supervises, leads, and mentors validation engineers and technicians.
- Provide the leadership, management of, and the oversight of validation activities.
- Develop a validation master schedule for computer systems with a resource requirements plan working with the functions.
- Accountable to site management for reporting the status, any potential delays, or technical issues which put at risk the execution of the computer system strategy and timing.
- Plans and manages budgets for validation activities and contract staffing. Ensures validation activities meet all requirements for FDA regulations. Reported to the QA Director.
- Created and maintained project timeline
- Meet with and report to client’s management as needed
- Provided on cGxP, Computer System Validation, Compliance
- Liaison between IT, System Owners, Quality Assurance and Vendors
- Simultaneously managed a portfolio of project
- Traveled as needed.
- Conducted cGxP and 21 CFR Part 11 Gap Assessment / Audits with CAPAs and remediation plans
- Authored SDLC Policy / SOPs - Master Validation Policy with supporting Validation Deliverables Templates (User Functional Requirements Specification, Remediation Plan, IQ, OQ and PQ Protocols, Test Scripts and Summary Reports, Supervised Script Execution, Traceability Matrix, Validation Summary Report, etc.) and SOPs
- Collaborated with all levels from diverse functional teams to define requirements and process for their area.
- Authored SDLC project deliverables i.e. Functional / User Requirements, Validation / Remediation Plan, Migration Plan, Test Plan, Protocol, Test Scripts (IQ / CIQ / OQ / PQ), Traceability Matrix, Summary Report, Retirement Plans, etc.
- Executed Test Scripts (IQ / CIQ / OQ / PQ)
- Supported data migration / data verification activities
- Applied 21 CFR Part 11, Annex 11, ICH standards, EMEA, GLP, GCP, GMP, GDP regulations, GAMP methodologies and general software development standards.
- Authored SOPs
- Provided support / SME in the purchase of software / instruments used in cGxP processes.
Quality Assurance / Auditor
- QA review / approve documents for compliance to FDA regulations
- Conducted peer review of project deliverables
- Built Quality System processes that included CSV
- Conducted both on-site and off-site (Phone/Electronic) audits.
- Performed necessary audit preparation, checklist, review SOPs.
- Conducted pre-assessments/peer audits
- Worked as a Lead Auditor and Audit Team Member
- Wrote - Audit Plans, Audit Summaries, GAP Analysis, Corrective and Preventative Action Plans, Risk Assessments, etc.
- Identified CAPAs
- Worked with CAPA Owner to identify strategies / timelines to close CAPAs
- Conducted effectiveness checks.
Change Control Agent
- Provided QA review for Validation Plans, Decommissioning Plans, Request for Change (RFC), Test Scripts (HPQC), Technical Specifications (GxPharma/PDOCS), Interface Design Document (IDD)
- Met with System SMEs to determine requirements/reasons for RFC, Test Scripts, Tech Spec, IDD
- Ensured supporting documentation properly traced to RFC, FR, Tech Spec, and Test Scripts
- Applied cGMP and 21 CFR Part 11 guidance as needed
- Update Validation Metric with known information and conducted research/analyst to gather additional information.
- Managed project and junior consultants - on and off shore (several locations in India / Dubai
- First line contact for both on/off-shore consultants (9+/-)
- Work with team to resolve conflict/issues
- Facilitated weekly team meetings and coordinate the presentation of project Hot Topics, which fostered cross, etc.
- Wrote semi-annual appraisals
Confidential, Shelton, CT
Quality Administrator / Team Administrator
- Multi-tasked positions included: Technical Writing, Auditing, Systems Analyst, and Administrator for Corporate Quality Programs, Corporate Initial Quality Customer Satisfaction process, Corporate Employee Quality Recognition Program, Intranet/Web Designer Administrator, Trained and supervised administrative staff.
- Wrote and analyzed system/user specifications for Initial Quality Customer Satisfaction database and worked with IT to implement applications.
- Met with end users ( corporate and regional) to determine their requirements and to gain clarity of project life cycle. Implemented pilot program to identify program bugs and deficiencies.
- This process and application was used as a Best Practice for all Confidential Electronic companies.
- Trained European and Latin American employees in the process. Process also won the Confidential Electronic Customer Champion .
- Writer of corporate SOPs, Policies, Procedures, Practices and Best Practices found in Confidential ’s Quality System (System audited by the FDA and met GMP guidelines).
- Intranet Administrator/Web Design
- Appointed to BEST team (consisted of Vice President, Director of Quality and Regulatory, and several Business Process Managers)
- Developed marketing plan used to initiate the strategic planning process for the development of BEST
- Compiled quarterly Balance Scorecard information and distributed to organization
- Generated Hoshin goals and worked with the functional manager on agreement of final objective
- Developed and facilitated workshops in the regional offices as well as corporate office to introduce the BEST business model
- Analyzed Initial Quality Customer Satisfaction Survey responses:
- Ensured maximum customer satisfaction
- Identified dissatisfied customers and escalated/closed regional follow-ups
- Facilitated monthly customer satisfaction meetings attended by executive staff, marketing, sales, region executives and other key employees
- Initiated procedures to provide assistance to regions, modalities and other areas affected by the Initial Quality Customer Satisfaction process in reaching World-Class standard of 80% “Delighted” customers.
- Worked closely with domestic and international employees to resolve customer satisfaction problems.
- Designer and editor of the Quality and Regulatory Affairs Intranet Home Page and the Business Excellence Newsletter.
- Coordinated/organized domestic (company-wide) and international conferences and meetings.