Title: QA Project Manager (Manufacturing & Medical Device Products)
Location: Columbus, OH
Duration: 12 Months
Job Summary
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 Abbott 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.
Job 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
Education
- 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 problem-solving abilities and knowledge in nutritional manufacturing controls and quality systems
- Continuous improvement methods and application (for example: Lean, Six Sigma, Class A, etc.).
- Cross-functional/cross-divisional stakeholder management experience
- Experience dealing with international locations
Preferred
- Master’s degree
- PMP certification
- Ingredient expertise, process expertise, and formulation expertise in nutritional industry
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.
