Project Manager/Operations Leader
Accomplished, and certified Project Management Professional PMP with an MBA and leadership experience in pharmaceutical operations and quality compliance in GMP and GLP environments. Experienced in the improvement of business processes and project management in an FDA Consent Decree environment. Excellent communication and liaison skills that build effective relationships within cross-functional teams and among diverse stakeholders that drive successful projects.
| || |
Project Manager Consultant - Validant
Project Manager for External Manufacturing EM business continuity plan. Manage OTC Tech Transfer to contract manufactures and packaging facilities as a result of an FDA Consent Decree at McNeil manufacturing sites. Lead cross-functional teams of internal and external partners to initiate and execute project plans. Manage the audit remediation plans at EM sites for McNeil.
- Manage projects to transfer and validate OTC manufacturing and tablet compression at EM sites.
- Define project scope and deliverables to support business goals in collaboration with senior management and key stakeholders.
- Effectively communicate project expectations to team members and stakeholders.
- Responsible for identifying risks and developing mitigation strategies to avoid project delays.
Senior Project Manager
Supervised four Project Engineers in the execution of Packaging Innovation R D packaging designs projects for class II and class III medical devices. Responsible for the Packaging Innovation 3 million dollar annual budget. Manage the validation of new medical device packaging designs in accordance with ASTM, ISO Standards and internal SOPs. Responsible for the resolution of packaging related non-conformance reports and CAPA plans. Manage the final closure of multi year project for FDA required packaging remediation. Manage the review of packaging product surveillance data.
- Manage new product packaging projects via MS Project in conjunction with R D PMO.
- Packaging Innovation leader for Stryker due diligence teams for potential acquisitions and packaging remediation of Stryker Orthopedics acquired companies.
- Manage Packaging Innovation project portfolio via PDWare.
- Project Manager for the qualification of a Class 7 clean room, shipping simulation equipment, and test instruments used in packaging design validation.
- Responsible for the review and approval of packaging change controls.
- Manage internal Tech Transfers for new packaging designs.
Senior Project Manager
Initiate, develop, and evaluate plans for projects. Plan the execution of all tasks needed to achieve goals or modify techniques to obtain the best results and satisfy the customer. Develop project strategies, work breakdown structures, milestones, risk assessments, and deliverables in consultation with management and project team. Serve as a source of expertise in project management for Global Quality Analytical Development GQAD worldwide offices. Direct the efforts of junior project management staff on projects. Manage the annual budget planning process totaling 15 million, for three GQAD groups.
- Project Manager for the installation and qualification of a 2 million, USP Water Purification System for the GQAD site at Pearl River NY.
- Manage the investigation process for approximately 75 unique forensic and counterfeit laboratory investigations per year for Pfizer vaccine and pharmaceutical products.
- Responsible for progress reporting of business critical and regulatory-based projects from GQAD worldwide offices on a monthly basis to VP level of management.
- Project Manager for the installation and qualification of Global Quality Reference Standards Chill Room 24/7 central monitoring and power back up.
- Project Manager for all regulatory audit preparation, responses and remediation, for GQAD.
- Manage GQAD laboratory-testing projects at Contract Research Organizations CRO .
- Project Manager for Consumer Health Tech Ops in a new formulation re-launch of Centrum line of nutritional supplement.
- Tech Ops Project Manager for a 1.25 million control upgrade project for USP Water Purification System ahead of schedule and within budget for Pfizer Consumer Health Technology.
- Tech Ops Project Manager for the line extension of Centrum Kids nutritional supplement.
Project manager for manual healthcare claims processing workflow redesign project. Managed 5 supervisors and 150 associates. Increased claims productivity 23 by establishing claims processing goals and category standards.
Production and Packaging Advisor
Department supervisor for 30 Hot Fill production and packaging specialists to ensure efficient labor and resource allocation. Achieved a 20 reduction in overtime requirements for line changeovers.
Shift Supervisor of 30 laboratory technicians and chemical operators in the production and process control of colored pigments. Project Manager for process re-engineering project that decreased production turnaround time by 10 and achieved over 40,000 annual savings.
Invoice and Planning Analyst / Senior Research Technician
Coordinated 20 worldwide offices to ensure logistical support for Fuels and Marine Marketing. Project Manager for New Technology Labs facility closing directed initiatives that reduced overall project costs by liquidating surplus equipment.