SENIOR QUALITY ASSURANCE LEADER

Computer / IT Systems Process Cleaning Manufacturing Risk Management Laboratory Equipment validation, Microbial Contamination in production facilities CSV/CSA Validation and Documentation FDA Compliance and Consent Decree Remediation

Global quality assurance leader initiating continuous quality improvement to enhance business processes, achieve efficiencies, and strengthen competitive advantage. Improve QA and reduce compliance-related costs while speeding NDAs and removing FDA warnings to achieve greater pipeline revenues using a proactive, risk-based approach. Expertise spans pharmaceuticals, biotechnology, medical devices, foods, and cosmetic industries. Experienced as an ISO 9000 certified auditor with background in international and regulatory quality standards.

KEY COMPLIANCE PROJECT AND ACHIEVEMENTS

Turned around FDA consent decree remediation process for a $20B pharmaceutical giant, establishing validation procedures for existing, new, and upgraded systems. Validated and documented 150+ of mission-critical, enterprise-level computer systems, including laboratory systems and created Level II corporate standards and site-specific Level III SOPs.

Expedited implementation of corrective actions for a $14B biotechnology company to resolve FDA’s major findings and headed a five-site, global team in standardizing validation process for enterprise computer systems and compliance risks.

Selected by FDA to serve as compliance and regulatory lecturer for pharmaceutical industry, was instrumental in development and implementation of the 21 CFR Part 11 regulations and performed regulatory audits to address Part 11 compliance issues and data integrity.

CORE COMPETENCIES

Project Management Business Process Analysis Equipment and Computer Validation Total Quality Management

Analytical Method Development for Microbiology Lab Training Development Risk Management

Data Integrity Assessments for GMP Computer Systems CAPA Remediation Auditing Vendor Management

PROFESSIONAL EXPERIENCE

INDEPENDENT CONSULTANT 2007 – Present

Provide consulting for medical and pharmaceutical industry clients. Serve as the quality lead and project manager in current role for all global computer system projects for an animal health company located in the Mid-west. Coordinate and define critical tasks to meet tight timelines, implement resources management between France and manufacturing sites, and perform costs analyses for all projects. Create validation documentation, develop training programs, and develop global SOPs governing the computer validation process.

Created global training content and materials regarding computer system validation in preparation for FDA inspections as well as analytical methodology development for new products for medical device and biotech companies.

Formulated and implemented a diagnostic company’s validation process for a laboratory management system, developed cleaning validation processes for a nutrapharmaceutical company in response to a FDA inspection, and spearheaded a validation program involving clean room manufacturing equipment, with equipment including a vial washer, autoclave, incubators, and stability chambers, and created and implemented a validation for the Kay Validator.

Served as quality advisor involved in corrective actions associated with SAEs of a medical device that resulted in recalls.

Served as the quality lead involved with validation of manufacturing equipment such as autoclaves, vial washers, and incubators for a manufacturer of Phase II and Phase III clinical materials.

Performed vendor audits to address quality issues regarding the manufacturing of glassware and raw materials used in development of clinical materials for a Contract Manufacturing Company (CMO).

Initiated a Part 11 and Compliance Risk Assessment Program for a small medical device company for the resolution of FDA inspectional issues.

Served as the technical, validation, and business lead for global implementation and validation of SAP for a medical device company involved in the manufacture of IVD’s and developed a business process and strategy that addressed corporate requirements for the implementation of SAP globally.

Developed and spearheaded the implementation of an FDA inspection readiness program focusing on QSR and ISO regulations for the medical device industry.

Served as a technical lead for a major pharmaceutical company in development of validation discrepancy reports and for implementation of corrective actions for a manufacturing SCADA system validation that entailed reviewing source documents and PLC ladder logic source code.

Served as a senior validation lead for validation of an HVAC system and clean room utilities and for development of an Environmental Monitoring Program for a start-up clinical manufacturing company in Northern California.

Served as site QA lead for a generic pharmaceutical manufacturer involved with development of a CGMP Training Program covering topics addressing GMPs, good documentation practices, CAPA resolutions, and project life cycle methodology for process, equipment, and automation validation projects and was involved with development and associated training for upcoming FDA and MHRA inspections.

Investigated and remediated CAPAs for product recalls and customer complaints for a major medical device manufacturer of Class IIII medical devices, with remediation involving root cause analyses, risk assessments, and QRB presentations.

Performed a retrospective evaluation / gap assessment for regulated computerized systems in the QA / QC areas for a generic pharmaceutical company located in Pune India in response to FDA 483 inspection observations.

Served as a risk management facilitator for combination products under an FDA warning letter for a global biotech company on the West Coast.

Participated on a task force team to update and review all Annual Product Reviews (APR) for manufactured injectable marketed products for a generic pharmaceutical company in North Carolina.

AMGEN, INC. 2006 - 2007

Director of Validation and Compliance

Directed an 8-member group through validation and implementation of enterprise computer systems and led Computer Validations All Sites team in global governance for computer validation, regulations, and best practices.

Pioneered FDA readiness inspection process and training program for the Information Services and Quality departments.

Initiated quality measures related to a Learning Management System (LMS) upgrade, LIMS upgrades, and implementation of SAP and implemented global risk-based validation program for existing and future IT projects.

Introduced tracking system utilizing dashboard data to document project status / milestones, enhancing communication and ensuring completion of global high-profile projects.

Initiated a review system in conjunction with senior management to evaluate and set project priority levels, budget / resource allocation, scope, and timelines for new and existing projects.

WYETH PHARMACEUTICALS 2002 - 2005

Manager, Quality Assurance Information Systems, 2003 – 2005

Managed 20-member quality team overseeing computer validation, system implementations, and upgrades, and framed procurement parameters for manufacturing and laboratory computer systems.

Structured a harmonized computer validation process, updated SOPs, and instituted global training program.

Analyzed validation documentation prior to submission to FDA, coordinated quality assurance team and third-party resources as well as spearheaded remediation in manufacturing and laboratory areas.

Oversaw FDA-mandated phased verification process for consent decree remediation and enterprise systems verification and supported CAPA system, integrating corrective actions within standard operations.

Served as the quality lead for the implementation and validation of enterprise systems, including Laboratory Information Management System (LIMS), Chromatography Data Acquisition System ( CDAS), SAP, and Documentum System (Gx Pharma).

Manager, Global Computer Systems Validation, 2002 – 2003

Provided management and incorporated quality / compliance policies and best practices in remediation / verification of enterprise systems.

Designed Part 11 assessment process for legacy systems to align with FDA regulations, selected and supervised consultants, supported legacy systems, and resolved gaps in cGMPs.

Became instrumental in formation of corporate disaster recovery and business continuity plans for manufacturing systems.

EDUCATION

Master of Arts (MA), Biology / Microbiology

Montclair State University

Bachelor of Science (BS), Biology

Bloomfield College

CERTIFICATIONS

Certified ISO 9000 International Auditor - Quality Alert Institute

PROFESSIONAL AFFILIATIONS

International Society for Pharmaceutical Engineering American Society for Microbiology

Parenteral Drug Association National Association for Female Executives LA World Affairs Council

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