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Planet Pharma · 8 hours ago

Manager, Project/Program Management

Irvine, CA

Full-time

Onsite

Senior Level

$60/hr - $68/hr

6+ years exp

Planet Pharma is seeking a Manager of Project/Program Management to lead New Product Development teams in the medical device industry. The role involves managing all aspects of program execution to ensure timely commercialization of innovative products while adhering to quality standards and regulations.

BiotechnologyHealth CarePharmaceutical

Hiring Manager

Patrick Sazama

Responsibilities

Manages one or more large scale to enterprise-wide projects within program, assuring strict adherence to company APM’s Quality Systems and Change Control Process

Facilitates the creation and approval of business cases within the program, and coordinates the sharing and prioritization of resources among projects

Develops a detailed plan for the program and manages program change accordingly

Executes program plans (quality, risk, communication, staffing, etc.) and communicate program status and data to maintain accurate and current program information for the use of stakeholders

Leads core team meetings and other necessary meetings to drive best in class program execution; Continually improves quality and effectiveness of how meetings are run, decisions are made, and how work gets done

Serves as a project and program management subject matter expert, including guiding and mentoring peers

Demonstrates high emotional intelligence; builds trust, rapport and respect with project team members and stakeholders; Engages in honest and transparent conversations

Creates a culture where teams can act with a high sense of urgency and accountability to meeting/exceeding individual and project goals

Understands complex problems and drives the team to effective resolution

Displays perseverance and continues appropriate forward momentum by keeping core team engaged, even when faced with crisis, and/or changes

Demonstrates strong ability to influence downward, horizontally, and upward

Qualification

Medical Device ExperienceAgile/Scrum MethodologyProject ManagementPMP CertificationSpanish Proficiency

Required

Completed Bachelor's Degree or Master's Degree (Preferably in an Engineering Field)

A minimum of 6 years of hands-on experience managing New Product Developments projects and/or programs of increasing complexity

Demonstrated track record of successfully managing and leading projects in the medical device industry that incorporate a mix of Software, Firmware, and Hardware and Disposable components

Proficient understanding of Medical Device Regulations and Product Development Process

Must have device/medical device experience (need to understand quality, reg, and PCP processes)

Must have a track record leading different types of projects with device deviations, regulations, and product cycle processes

Working knowledge of Agile/Scrum methodology and related project management software: Jira, Microsoft DevOps, etc