Quality Intelligence Project Manager

Experis IT ManpowerGroup has partnered with a leading Medical device organization in the Columbus, OH for a Quality Intelligence Project Manager role to assist their team. This is an on-site role. 
 
Industry:         Medical device
Title:                Quality Intelligence Project Manager
Pay Rate:       $35-40/hr on W2
Location:        Columbus, OH (100% onsite)
Duration:         12 months contract with possible extension or hiring

 
Job Description:
This position will lead medium to large scale projects to support ANSC Quality Assurance strategic and compliance objectives. This position has the broad objective of supporting quality activities globally for AN Division QA, AN Affiliate QA and ANSC Manufacturing sites US and OUS.

This position will independently interface with affiliates, AN Division, AN manufacturing plants, R&D, Regulatory, Supply Chain and others. The position will successfully achieve the objectives through effective communication, change management, stakeholder management, strong interpersonal and presentation skills.

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 updates


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

Education:
Engineering, food chem, microbiology, regulatory Master’s preferred but will accept Bachelor’s.