Sr Project Manager - Quality

Job Summary

The position will guide the development of medical devices, dietary supplements, cosmetics, and/or OTC drugs. Lead collaborative, multifunctional teams consisting of R&D personnel, quality, regulatory, manufacturing, and product divisions.

Will serve as a subject matter expert on all phases of product development and is responsible for managing and overseeing all aspects of a project portfolio spanning multiple priorities and functional areas.

Major Responsibilities

• Manage the product development process utilizing various project management frameworks such as iterative agil e.
• Manage project portfolios and ensure that project and divisional goals are aligned.
• Provide updates to and advise divisional leadership on project status and opportunities.
• Collaborate with product divisions to compile strategic plans, establish innovation pipelines, and align product development efforts with long-term divisional strategies.
• Manage assigned projects, balance corporate priorities, and ensure team alignment across functional areas to ensure that project deadlines and goals are met.
• Develop, communicate, and track project plans, objectives, budgets, scope, timelines, and projected end dates.
• Translate project goals into project tasks.
• Leader in the use and application Medline's Project Management Portal to execute projects effectively.
• Leverage lessons learned to conduct risk assessments and identify issues that may cause project delays or cost overruns.
• Develop and implement contingency plans to mitigate the impact.
• Compile risk profiles associated with scope creep and changing project requirements.
• Maintain team morale and engagement by ensuring constant and transparent communication. Generate team consensus.
• Lead project and process best practice guidance to cross-functions team members. Supervise, coach, and train junior staff.
• Compile technical justifications and data summaries in support of product claims.
• Lead process improvement initiatives or additional quality initiatives as project manager.
• Keep current with regulatory guidelines, technical innovations, and new developments within the medical device or pharmaceutical industry.

Minimum Job Requirements

Education

• Bache lor's degree in Engineering or S cience related field.

Licensure/Certification

• PMP Certification

Work Experience

• At least 4 years of experience in a medical device, pharmaceutical, dietary supplement or cosmetic related field.
• At least 2 years of project management experience.
• Experience in the development and launch of new medical/pharma /dietary supplement/cosmetic products.
• Experience with medical device requirements (Class I-II), design controls, risk assessments, and the 510k process.

Knowledge / Skills / Abilities

• P roject management tools and techniques.
• Knowledge of medical device requirements (Class I-II), design controls, risk assessments, and the 510k process.
• Position may require travel up to 10% of the time for business purposes (domestic and international).