Global Operation Program Lead (QA/RA) - Remote

Working Location: CALIFORNIA, SAN JOSE; Nationwide 

Workplace Flexibility: Field

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

 

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

 

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

 

We deliver on our purpose and our core values by staying True to Life.

Job Description

The Global Operation Program Lead responsible for enabling Global cross-functional team members to leverage their expertise into project realization, driving project teams in the efficient execution of new product development, and other strategic projects towards time, cost, and specification goals. The Global Operation Program Lead will own documentation and tracking of all programs including definition and execution to a stage gate process, regular cadence of meetings/reviews, reporting, program metrics, and Quality Planning Elements & Medical Protocols. The Global Operation Program Lead will assist the organization in project prioritization and resource management while effectively communicating program status, anticipating and escalating program issues, and proposing solutions to meet project goals based on expertise and experience. The role best suits a candidate who is highly organized, articulate, and hands-on, comfortable communicating at all levels of the organization, managing conflict, influencing resources outside one’s reporting structure, removing obstacles, driving progress, and maintaining accountability.

Job Duties

• Own and Lead program management for the Center of Excellence Complaint Inquiry efforts and represent the Center of Excellence Global Complaint Inquiry as the functional area representative on projects outside of the department which impact Global Complaint Inquiry.
• Manage Center of Excellence Global Complaint Inquiry projects across strategy execution with, and communication to, internal and external customers, business partners, regulators, and sr./executive management.
• Serve as the liaison between complaint handling sources and Global Complaint Inquiry with a goal to improve workstreams and processes and eliminate operational inefficiencies by 15% within one fiscal year.
• Support development of change management initiatives, implementation strategy, and enhanced tools/processes.
• Create and maintain Global Complaint Inquiry SOP document(s) with a goal to document all market SOPs in a single repository within one fiscal year.
• Develop strategic guidance by connecting disparate conversations, workstreams, and data, and synthesizing feedback to management.
• Collaborate effectively and build key relationships with stakeholder teams to identify and manage milestones and overall plan.
• Promote awareness and transparency by keeping stakeholders informed of key decisions and relevant milestones and serve as program owner for communication of program status.
• Establish and maintain Center of Excellence Global Complaint Inquiry audit and inspection readiness plans.
• Lead an inspection knowledge Global assessment for Complaint Inquiry geographies and operations to identify potential for similar audit/inspection findings and/or observations.
• Lead cross functional remediation projects or corrective actions to address internal, external audit/inspection findings and/or observations. 

Job Qualifications

Required:

• Bachelor’s Degree required. Advanced Degree preferred. 
• Minimum of 5 years of medical device and/or pharmaceutical industry experience or other regulated environment.
• Minimum of 5 years Program Management experience leading complex strategic or transformation initiatives in a large technology organization, including organization effectiveness or process re-engineering.
• Minimum of 5 years of experience providing work direction and leadership to people and teams.
• Experience with large-scale organizational change efforts.
• Literacy in complaint handling and service systems modeling/analysis.
• Up to 50% domestic travel, occasional international travel may be required.

 

Preferred:

• Ability to execute and maintain high performance under tight timelines.
• Superb written and verbal communication; advanced or expert PowerPoint and visual presentation skills; advanced or expert Excel skills.
• Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact.
• Advanced Influence Manag