SUMMARY:

Motivated and energetic quality systems professional with over 20 years’ experience leading project teams to implement quality system management processes and improvements in dynamic environments, including automotive after - market part manufacturers and Confidential -regulated pharmaceutical and medical device providers. Expertise in CAPA management, cGMP quality systems and compliance with federal regulations. Highly-effective change agent and innovator of team training programs. Technical Proficiencies include MS Office Suite (Excel, Word, PowerPoint, Outlook), PTC Windchill, Trackwise, Master Control, ETQ, and Documentum / EDM.

AREAS OF EXPERTISE & TECHNICAL SKILLS:

• Regulation Compliance
• Final Drug Product Release.
• Internal/External/Supplier/Regulatory Audits
• Batch Review/release
• Deviation/CAPA
• Pharmacovigilance (Pre and Post)
• Veeva Vault/Trackwise/ETQ Work Flows
• Written Communications
• Biologics/Gene Therapy
• Quality System Management & Implementations (GMP)
• GxP Compliance (ICH E6)
• Project Life Cycle
• Technical Writing
• Process Improvements
• Sterile/Aseptic Processes
• Consent Decree Remediation
• Inspection Readiness
• Safe Quality Food (SQF)
• Six Sigma (Green Belt)
• Document Control
• Software Implementation
• CFR 210/211/820/803/806/58/11
• Team Training & Development
• ISO 9000/13485/14001
• Lean Management
• HAACP Certification
• Phase I-III Trials
• Change Management

PROFESSIONAL EXPERIENCE:

Confidential

GMP Quality Systems Remediation Consultant

Responsibilities:

• Perform analysis of GMP Quality System for Orphan Drug program.
• Lead Quality System upgrades and reorganization to meet CFR 210/211, ICHQ7A, Health Canada and European Union Regulations.
• Reorganize Supplier Program to obtain more oversight of CMO contract with RRDNA to perform bulk manufacturing of API and BDS products.
• Redesign of Vendor qualification, training, and CAPA programs. Revision of programs
• Reorganize complaint handling systems including feedback, investigation methods and final record filing responsibilities.
• Manage Product Release and Testing processes from CMO and CLO orgs
• Qualification of API and BDS product suppliers.
• Serve as the QMS expert for Veeva Vault Quality Docs, including acting as the prime system administrator including the processing of changes to the systems and re-alignment of the system configurations against CFR Part 11 and CFR 820 expectations.

Confidential

GMP Medical Device Quality Systems Implementation Director

Responsibilities:

• Inspection Readiness to prepare facility for first Confidential Compliance audit. Including, training of employees on the process, performing a mock audit with staff and stake holders, offering guidance on best practices to help alleviate stress and roadblocks.
• Implementation of fully compliant CFR 820 Quality System including, Non-Conformance, Deviation, CAPA, Change Management, Supplier Quality Approval, SCAR, Complaint and Recall processes and Procedures.
• Provide 1 on 1 coaching and mentoring with each staff member to help alleviate the stress and anxiety with the vast changes taking place in the environment.
• Holding weekly team meetings to elicit feedback (Good and bad) on how the changes are affecting productivity and day to day business operations and providing support service to help staff and personnel adjust to the new Quality System changes.
• Ground Up Constructions of 250+ New Quality Controlled SOPs, WI’s, FORMS, Policies and governance documents.
• Preparation and simulation of Confidential audit Readiness with a steady growth of improvement in reaction time, document readiness, and response readiness.

Confidential

Project Manager

Responsibilities:

• Implementation and configuration of standard OOTB Master Control Suite 11.5 Phase 1 for:
• Change Management
• Training/LMS
• Document Management
• Selected key QA/BA team members to implement the FBS (Field Business Solution Suite) of Master Control 11.6, for Phase 2 implementation that includes:
• FBS Complaint
• FBS Non-Conformance
• FBS Deviation
• FBS Issue Review, Event and CAPA
• Drive Steering committee and develop USER requirements through the Scrum Agile workflows to configure and implement the software suite
• Review existing QMS processes for alignment to FBS solution package
• Drive and select team members to revise existing eQMS processed to align with new FBS eQMS Master Control programs
• Receive feedback and input from Test users on performance and overall flow layout. Using metric data to improve on Hang-ups, trouble spots and confusing operations requests. Provide revised environment for further team feedback.
• Implementation completion, system training and delivery completed 3 months ahead of schedule.

Confidential

Acting Lead Quality Director

Responsibilities:

• Apply Lean methodologies to creating a sustainable Document Management Process, CAPA Management, and MBR approval.
• Identification of Non-Value-added Attributes that slow down processes by replacing with Value-Added Attributes.
• Evaluate Clinical Quality Assurance practices against clinical policies in effect at organization.
• Coordinate and Qualify potential eQMS suppliers for eQMS implementation.
• Identify resource gaps through organization
• Implement Part 11 compliance systems.
• Implement DMAIC methods for Deviation Management.
• Monitor and Manage GCP Programs under ICHe6.
• Audit and vendor program management
• Trial file review.
• Support Submissions and Updates.
• Procedural Documentation
• Pharmacovigilance program administration
• Build and Structure Document Management Programs (SOP, Policies, Manuals, POU Manuals)
• Implement Pharmacovigilance Processes and Training.
• Acting regulatory oversight during remediation of the corporate wide Quality systems, including oversight of 12 consultants tasked with improvement of companywide policies.
• Development of Pharmacovigilance training and policies
• Implementation of Veeva Vault QMS and Veeva Quality Docs Cloud Based eQMS and Compliance Wire LMS system
• Identify and design business process work flows for eQMS system using Veeva Vault Quality management.
• Work with each individual department manager to determine needs and requirements translating those into user friendly work flows within the Veeva Vault atmosphere.
• Oversight and Control of the Stability Programs via Quality Assurance processes. Including times-lines, deliverables and reporting needs.
• Implement Supplier Quality/Qualification Program for the Manufacturing and Testing of Phase I-III Oncology drug material
• Manage Data integrity for Audits, Clinical Trials, GMP Manufacturing and external/internal Quality Systems

Confidential

Senior Quality Professional/Manager/Director

Responsibilities:

• Conducted cGxP quality systems process audits and implemented HACCP for QMS organizations.
• Design, implement and execute CAPA Programs related to Audit Findings, Process Investigations, CRO issues.
• Includes all Documentation and follow up with responsible CAPA owners and stakeholders
• Reduction in CAPA failures by 10-37% depending on organization (Teva achieved highest reduction)
• Identify gaps within organization vs. regulatory compliance for future commercial manufacturing.
• Implement cGxP Industry standard practices to aid in oversight of processes and compliance. Including, updating of aging practices being utilized at the facility. (All Clients)
• Apply Lean methodologies to streamline Document, CAPA, and MBR approval Management processes. (Immunomedics)
• Using Quality Function Deployment principles build and implement Document Mgmt. System.
• Identifying Non-Value-added Attributes that slow down processes by replacing with Value-Added Attributes.
• Design, implement, or manage ASEPTIC processes for the purposes of Bulk and Final Drug product manufacturing.
• Administrate Supplier/Vendor programs including Qualification and SCAR actions.
• Provide Training Services for cGxP Compliance, including Non-Conformance, E-Systems, and Pharmacovigilance.
• Shape and evolve relationships between Quality Organizations and Manufacturing Organizations to achieve a cohesive relationship for the purposes of compliance.
• Serve as a distinguished member of Quality Review and CAPA review boards.
• Perform complex and detail investigations for Health Hazard Evaluations for the purposes of Product Field Actions.
• Remediate Quality Systems found to be out of compliance with the CFR as determined by Confidential Warning Letters/Consent Decrees.
• From a Quality perspective serve as a member of the drug development team for cGxP processes on Phase I-III Clinical trial materials
• Coordinate Change Control and Change Management programs to ease the burden on business units affected by the change process.
• Perform cGxP Audits of CMO, CRO and Supplier programs from a Quality Perspective for regulatory compliance
• Design History File management in accordance with the CFR and ISO 13485.

Confidential

Compliance Specialist

Responsibilities:

• Perform facility audits on a monthly basis determined by pre-define schedule.
• Evaluate and monitor Aseptic processing areas
• Perform Nonconformance investigations and moderate CAPA programs
• Serve as a member of the internal QRB and CRB.
• Perform essential QA on the floor/Compliance on the floor facility inspections of Lab and Manufacturing Areas.
• Evaluated failures of change control remedies. (McNeil)
• Determined deviation impacts on manufacturing processes during triage and disposed of quarantined materials.
• Address findings within Confidential issued Warning letters and/or Consent Decree Obligations.
• Documented work flows and created comprehensive training plan after manufacturing team audit revealed 483 findings of training and performance deficiencies.
• Used ADDIE techniques to introduce training programs in SOPs, auditing, and other multi-use quality system programs and processes.
• Implement Quality By Design Principles lead remediation activities for CAPA Programs, Validation Activities, Lab Protocols, and Manufacturing Process redesign.
• De-commission of original licensed facility located @Watkins Mill Rd in Gaithersburg.
• Assist process engineering with the commissioning of the 6 floor, 300,000 sq ft. Pilot facility built in 2006.
• Administrate and train users on the batch Processing system through Windows 2003 Server terminals.
• Perform weekly New Employee compliance orientation.
• Management of the Manufacturing LO/TO program as a member of the EHS team.
• Develop training programs and modules for the Compliance Wire LMS system.
• Issue and Track all Equipment and Room use logbooks
• Review and Approve all clinical trial batch processing records and solution preparation records.
• Mentor 4 junior associates.
• Maintain all GMP manufacturing records.
• Facilitate Change Management programs