QMS Project Manager

2 weeks ago

Round Lake, United States Integrated Resources Full time

Essential Duties & Responsibilities

Provides analytical support to the Project Management Office under minimal supervision.

Proactively participates in processes and makes recommendations for system refinements within the Project Management Office.

Support Planning Sessions as documentation lead and/or workstream lead.

Performance Management Participates in the evaluation and feasibility process for potential projects.

Provides clear direction on project requirements to meet expectations of external customers and business stakeholders.

Interacts through program and/or project updates and reviews with all levels of management.

Drives implementation of projects by establishing strategy, schedules, budgets, and financial analysis.

Drives use of Project Management Methodology throughout projects. Approves team deliverables for project completion.

Risk Management Leads team in risk management approaches and systems.

Responsible for making decisions regarding the appropriate risk when there is substantial project or program impact.

Administration Ensures appropriate linkages of this information to the project prioritization and/or portfolio process.

Maximizes business results through continuous improvement in organization's ability to execute projects and programs from initiation to completion and production scale-up.

Owning SharePoint site, tracking and execution of Product and financial deliverables and associated reporting.

Finance Management Provides financial analysis and justification for new projects or programs.

Monthly financial updates (submitted via SharePoint) Issue Resolution Eliminates or minimizes barriers to progress.

Anticipates potential conflict situations, identifies and acts on proactive solutions. May perform other duties as assigned. Communication Weekly and monthly SharePoint updates of Initiative and Milestone Status Participation, including presenting updates/escalated items and fielding questions, in the standing global Master Planner meeting Escalation of issues, risks, and changes via established Integration Management Office (IMO) and Quality Workstream communication mechanisms Utilizing and enhancing standard reporting and communication tools to ensure appropriate and timely communication and reporting from multiple projects and quality/regulatory Core Team members Meeting participation/facilitation Quality Management Systems Execution to completion of harmonized process/quality system element roll-out. This will require collaboration with the Manufacturing Integration team Execution of outstanding process/quality system element assessments. This will include coordinating document owners and SMEs to ensure harmonized end state/content/IT tools; working with Manufacturing Integration team to develop change plans, and completing issuance/roll-out of processes Participation in and execution of elements of the Quality Integration Workstream Core Team and Communication Plan Qualifications Knowledge of cGMP manufacturing.

Knowledege of Quality Systems Must have the ability to correctly complete high school-level mathematics.

Must be able to read and follow detailed written instructions and have good verbal/written communication skills. Must be able to read, write, and converse in English.

Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training, performance management, and self service applications.

Must have the ability to navigate electronic mail systems and intranet for communication purposes. Advanced word processing skills. Advanced spreadsheet skills.

Advanced typing skills. Good interpersonal skills and be able to work effectively and efficiently in a team environment.

Must have ability to lead cross-functional teams. Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.

Must have passion to innovate and drive for solutions. Must display personal accountability for results and integrity. Must display eagerness to learn and continuously improve. Must have uncompromising dedication to quality. Must have relentless focus on rapid and disciplined action. Must have respect for individuals and the diverse contributions of all.

Education and/or Experience MBA/MS or Bachelors with equivalent plus 7 years project management experience and 10 years of demonstrated success leading multi-site, global or enterprise-wide programs in the medical products industry

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