Project Manager II(medical device)

Role: Project Manager II

Location: Columbus, OH - 43219

Duration: 12 Months

Main Responsibilities:

• Responsible for management and execution of multiple medium to large-scale projects that are organized into the Quality Intelligence Program Management Office (QIPMO) associated with regulatory requirements
• Cross-functionally remediate current and future regulatory impact on the quality system
• Ensure project scope is clearly defined: develop and manage project plans to meet deliverables
• Manage cross-functional project timelines and follow up with project team members to ensure timely completion of tasks
• Address any resource constraints associated through data driven business proposals to meet compliance requirements objectives and mitigate business risk
• Responsible for identifying and managing critical project issues and risks, and timely communication to senior leadership
• Provide clear and consistent communication, both oral and written to all project stakeholders on key project elements such as scope timeline, issues, etc
• Understand and support AN Commercial QA and Quality Assurance Compliance organizations and opportunities for improvements
• Integrate key AQR/AN QA initiatives as appropriate, based on compliance risk and availability of resources and business processes to support
• Recommend and implement strategies and enhancements to improve efficiency
• Develop and maintain effective KPIs that enable key success factors
• Coordinate Quality Intelligence operations and business cycle update

Skills:

• Minimum 5-8 years in a regulated nutritional food-manufacturing environment, preferably pediatric or medical nutrition products, in a Quality, R&D, Project Management or Operations function and good knowledge/awareness of food cGxP and nutritional regulations, Pharma knowledge and experience is an advantage.
• At least 3 years of management of complex projects or programs
• Demonstrated ability in managing expectations on program requirements and deliverables
• Demonstrated problem-solving abilities and knowledge in nutritional manufacturing controls and quality systems
• Well-developed interpersonal, communication and negotiation skills.
• Continuous improvement methods and application (for example: Lean, Six Sigma, Class A, etc.).
• Cross-functional/cross-divisional stakeholder management experience
• Applicable technical knowledge/experience
• Sound decision-making skills contributing to high levels of competence, confidence and credibility
• Experience dealing with international locations