Program Manager (Quality & Regulatory Affairs) - Remote

Plan and direct the execution of complex quality programs and projects across the global quality team relating to product improvement, process standardization or improvement, cost reduction, integration and regulatory compliance within the assigned portfolio. Responsible to directly, and indirectly lead cross-functional teams in the execution of end-to-end programs and project plans. This will include business case evaluation, budget analysis, resource requirements, detailed timelines, and risk assessments at the project and program level.

Job Duties

• Monitor project progress and report on project progress, problems, solutions. Identify and report project risks and initiate, implement and follow-up on counter measures.
• Define project plans including timeline, milestone, budget, and resources. Ensure project deliverables (incl. documentation, reporting of relevant project results etc.) are successfully completed through alignment and collaboration with customers and stakeholders.
• Lead value-add activities, such as hosting GIMBA walks, leading Kaizen events, facilitating pre-and post-mortems, and designing/facilitating brainstorming sessions.
• Serves on PMO and Project Steering Committees and provide regular project updates (written and verbal) to appropriate management and Olympus governing boards.
• Manage internal and external vendor relationships, including contract initiation and amendments, PO and budget, and vendor performance.
• Lead or support special quality and compliance projects as requested, and perform other assigned duties, as needed.
• Steer and monitor time, cost, people and quality within the managed projects as well and perform controlling and monitoring of financial aspects.
• Work with executive sponsors, business partners, global and regional teams, and subject matter experts to define project scope, structure, project plan and timeline.
• Focus on successful steering of diverse projects & programs in alignment with organizational goals.
• Directly manage specific projects and programs, as assigned. Leads large/complex projects and leads the project team. Lead multiple projects concurrently and/or some programs.
• Identify project goals and project deliverables in collaboration with project sponsor as well as relevant stakeholders and define project approach.
• Plan and ensure continuous communication, involvement, and alignment of all relevant stakeholders.

Job Qualifications

Required:

• Minimum of 8 years of experience in project management or technical experience in the medical device field or any other regulatory controlled industry.
• Bachelor’s or master’s degree or equivalent
• Ability to manage multiple projects and deadlines with competing priorities in a fast-paced and evolving work environment with a demonstrated track record of execution is required.
• Many years in complex projects or programs including first experience in portfolio management.

Preferred:

• The ability to lead and manage remote teams in both global and regional environments.
• Strong analytical, multitasking, time management, and organizational skills with focused attention on detail.
• Experience working with multi-disciplinary senior leadership members and analyzing, clarifying and translating business requirements into functional and technical specifications is a plus.
• Can build rapport, influence without authority, and motivate teams without direct management authority.
• Lean Six Sigma certification, preferred.
• Strong knowledge of project management concepts, tools, templates and methodologies and when to employ them.
• Ability to understand business needs/requirements and system capabilities to develop efficient and effective solutions.
• MS Project and project management tools.
• Experienced in strategic planning and risk management.
• Highly proficient in Microsoft Word, Excel, PowerPoint, Visio, Project, PowerBI experience preferred.
• Excellent interpersonal skills and experience working with different personalities, cultures and levels of management.
• Must have excellent influencing skills, communication skills, presentation skills and team oriented.
• Must have the ability to work under pressure achieving consistently high results in quality, efficiency, and compliance through individual and team efforts.

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