Denise Bachman Email & Phone Number

Fishers, Indiana, Us

BPM Associates is a consultancy focused on executing highly critical complex projects for our life sciences clients. We believe in the power of extraordinary people working together in a great environment to accomplish important, lasting change. We believe relationships matter. We put people first, and we aim to fulfill a service to a greater cause.

Fishers, Indiana, Us

With BPM, support biotech, pharmaceutical, and medical device clients through delivery of consulting services, including Project & Program Management, Transformation & Business Change Management, Quality Systems & CAPA Remediation and Audit Readiness, Drug Development & Clinical Studies, Pharmacovigilance & Product Safety, and Infrastructure & ERP Systems.

PM Works specializes in project management and change management in the life sciences industry. We have experience in drug development, pharmacovigilance, clinical studies, document management systems, regulatory affairs, compliance management, and sales and marketing.

Responsible for the project and change management work streams in a business transformation program. Driven by technology changes, the organization must transform people and processes from current state to a modernized future state. This is being managed through a structured organizational change management model that is comprised of defined phases and deliverables to ensure successful implementation, adoption, and increased ROI.

Program Manager working with executives to define initiatives and develop 2019 product portfolio. Provide recommendation on portfolio structure, program status, and interface with newly formed PMO. Support ongoing change management program throughout organization.

Consultant in a quality systems remediation effort for a medical devices company focused on developing and implementing CAPA and training systems and processes. Develop project plan, manage work stream timelines, create deliverables, and conduct training on new processes. Prepare and present project status presentations to management, track all deliverables to approval and closure. Develop meeting agendas, facilitate team meetings and work stream meetings with stakeholders.

Project Manager working in quality systems for a medical devices company, this project is focused on developing processes to ensure compliance initiatives are successfully implemented. Responsible for managing multiple work streams, resources and timelines, providing weekly project status to leadership, and writing procedures.

New York, New York, Us

Project Manager responsible for managing and reporting all CAPA activity within Global Product Safety at Hospira, a Pfizer company. Manage cross functional team between US, UK, and Manila with responsibility for global pharma investigations, CAPAs, and metrics. Improved closure timeliness of investigations by 45%. Contribute to integration plan between Pfizer and Hospira to ensure CAPA record transition aligns with new processes.

Project Manager at Astellas, a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. This project was with the PV Process Improvement program and had responsibility for up to 20 projects and teams comprised primarily of healthcare professionals based in Japan, EU, and US. Planned and managed project team timelines, scheduled and facilitated team meetings, reported status to senior leadership, Project Manager for Aggregate Safety Reporting group. Standardized and implemented management tools for better oversight of projects, resource work load, project planning.

BioPoint, Inc. is a leading global strategic consulting firm that combines deep life sciences industry knowledge with specialized expertise in drug safety, health economics and outcomes research, regulatory affairs, quality assurance, compliance and risk mitigation. Currently assisting the world's leading provider of injectable drugs and infusion technologies to optimize their business, improve their operations and risk profile, and advance their organizational performance to seize key opportunities.

Project Manager responsible for managing and reporting all CAPA activity within Pharmacovigilance and Global Product Safety for a leading provider of injectable drugs and infusion technologies. Responsible for the compilation, production, and oversight of health authority inspection proof books and inspection readiness. Manage cross functional team between US and UK with responsibility for EMEA region complaints and vigilance reporting tracking and metrics. Assist Vice President PV & GPS in front room during audit. First audit inspection with new processes implemented earned closure of open observations. Audit preparations also include readiness for US audit with FDA.

Western Springs, Illinois, Us

Manager for Indianapolis-based Praxis Management International, LLC. Prior to joining Praxis, I worked seven years as a consultant to a Fortune 100 pharmaceutical company. For the most recent nine years, I have performed as a project manager. The business areas where I have contributed include regulatory, quality, medical services, pharmacovigilance, and clinical in pharmaceutical and medical device business areas.

Ba, General Studies, Concentration In Literature

Education record