Program Manager Resume New York, NY - Hire IT People

SUMMARY:

Leader in defining strategies and IT solutions to meet regulatory, business, and competitive needs across the life sciences industry.
Expert in implementing people, process and IT projects of diverse size and complexity to drive tangible benefits for clients across the life sciences value chain: from discovery/ clinical research through post market surveillance.
Over 18 years of experience with a strong track record of the cross - team consensus building required to successfully deliver large scale projects for global organizations.

SKILLS:

Extensive experience in life sciences in: Regulatory Compliance, Supply Chain support/ realignment, Quality Management process definition/ implementation, Data Integration/ Analytics, Pharmacovigilance (PV), GxP (Good Documentation/Manufacturing, Practices, etc.) implications; and related process improvement/change management and organizational realignment.
Deep understanding of: IT efforts around: entire software development lifecycle (SDLC), IT Strategy, IT Governance, and Computer System Validation ( Confidential ).

EXPERIENCE:

Confidential, New York, NY

Program Manager

Responsibilities:

Met deadline set by board for initial cutovers by guiding 9 project managers and 30 other team members
Drove consistency as Single Point of Contact for all Quality, R&D and Legal IT related separation and “joint use solution” work, responsible for separating the data and users in over two dozen applications
Defined multiple strategies for applications that would be fully separated, shared, or cloned; jointly agreed upon by our separation IT and business partners
Mitigated disruptions and ensured full compliance with Confidential needs by implementation of detailed testing and cutover plans
Cemented success of cutovers by leading triage efforts for minor issues around data/user migration
Drove post Day 1 planning for remaining separations, ensuring clear paths and feasible exit timelines
Proactively mitigated risks using joint teams of IT, business, and compliance experts

Confidential, Warren, NJ

Project Manager

Responsibilities:

Resolved conflicting stakeholder perspectives to define, and garner consensus on: project scope, schedule and key milestones
Drove risk mitigation, issue resolution and change management
Identified and mitigated resource issues, leading team of over 12 developers and business SMEs
Proactively identified/resolved technical and process changes to minimize negative business impacts

Confidential, New York, NY

Manager

Responsibilities:

Assisted healthcare firms in meeting government regulations by successfully implementing people, process and technology based transformations.
Aligned project goals with client needs, defined achievable targets and led team to implement.
Acted as main liaison across project stakeholders—both internal and external.

Data Migration and Solution Validation Lead

Confidential

Responsibilities:

Led team in defining data migration requirements and analyzing migration results with stakeholders
Facilitated resolution of issues on a rolling basis to efficiently cleanse and align data in new solution
Defined Confidential needs to ensure validated, auditable state—gaining buy-in from client Quality team
Trained extended client and internal teams on Confidential needs and reviewed execution results

IT Integration Lead

Confidential

Responsibilities:

Defined documentation, testing and release requirements for validating systems
Led team in developing technical documents, test protocols and release plans
Led go-live and issue resolution efforts
Provided subject matter expertise in life science regulatory and manufacturing environments, and Confidential

Safety System Release Manager

Confidential

Responsibilities:

Defined Release Management strategy and tactical framework
Led implementation, test, and release ensuring completeness and minimizing user impact
Confirmed and prioritized bug fixes as well as requested enhancements
Ensured continued validated state of system through rigorous testing and documentation
Successfully transitioned process and capabilities to two client team members

Project Manager

Confidential

Responsibilities:

Created project schedules and negotiated compromises to ensure that roadblocks are anticipated and tackled to minimize impact to schedule, quality and functionality
Aligned rollout plans with customer organizational needs
Led coordination of Confidential effort across IT, Quality and vendor organizations
Guided and managed staff, contractors and software vendors to meet project milestones
Built strong working relationships with executive sponsors, IT stakeholders, and vendors
Developed and won $600K+ in additional services and support work