Quality Intelligence Project Manager
- Nice to have Quality, Regulatory, or Healthcare background.
- PM certifications. Nice to have but not required.
- Local to Columbus due to onsite requirements.
Our location in Columbus, Ohio, United States currently has an opportunity for Quality Intelligence Project Manager.
The Opportunity
- 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 Client 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.
WHAT YOU'LL DO
- 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
Accountability/Scope
- The quality and compliance of AN products is a competitive advantage in the marketplace, and any lessening of our standards or not meeting market requirements can have an adverse long-term impact on our business.
- This position will work with limited supervision.
Education and experience you will bring:
Required
- 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
Preferred
- Master's degree
- PMP certification
- Ingredient expertise, process expertise, and formulation expertise in nutritional industry
Education:
- Engineering, food chem, microbiology, regulatory Master's preferred but will accept Bachelor's.