United States - Ohio - Columbus
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
This position ensures that all Abbott Nutrition Pediatric products meet the highest standards for quality required by regulations and is responsible for leading a team of project leaders responsible for successfully leading QA related activities for launching new products, addressing product trends, leading investigations and risk assessments and identifying potential process improvements for the organization.
The Design Assurance Project Manager will lead a team of Project Leaders to assure product designs provide necessary safety, efficacy, regulatory compliance and customer satisfaction while balancing the need for speed to market as well as cost effectiveness.
The successful candidate will set priorities, drive continuous improvement, establish goals and metrics for the team of Pediatric QA Project Leaders. The Project Manager will work with cross-functional peers and managers ensure product quality and efficacy throughout shelf life and drive the performance of the Pediatric Design Assurance Team.
- Leads the Pediatric Nutrition Design Assurance QA team and provides guidance, direction and development opportunities for the direct reports.
- Develops strategies to measure and improve overall team performance, identifies SMART goals.
- Assures AN products meet FSMA, using HARPC and Microbiological knowledge
- Assures that the design and testing for all Abbott Nutrition Pediatric products are fully compliant with applicable regulations
- Facilitates product technical risk management activities through product development stages
- Facilitates investigations into complex issues and drives them to resolution.
- Works on problems of complex scope where analysis of situation or data requires review of defined factors
- Exhibits high level of technical competence in data analysis and product related calculations.
- Collaborates and provides leadership across the technical portion of the organization
- Identify/gain agreement on design criteria, negotiate compromises, balance quality with other criteria across all functional areas
- Displays working knowledge of relationships between regulations, labeling, process and product. Encounters differing but recurring problems and/or duties.
- Displays working knowledge of applicable product regulations (eg IFA) and policies
EducationB. S. in Science Related field (Food Science, Chemistry, Microbiology or other technical science area); Masters degree preferred.
- Ability to lead, develop and motivate a team of direct reports.
- Displays working knowledge of relationships between regulations, labeling, process and product.
- Displays working knowledge of applicable product regulations and policies
- Knowledge of FMEA, risk assessment tools
- Knowledge of leading root cause analyses (RCA) and proficient use of RCA tools.
- Knowledge of applicable regulatory standards and requirements for infant formula and nutritional products.
- Knowledge of quality management systems and regulatory requirements.
- Proficient technical writing skills; able to effectively and concisely communicate issues.
- Ability to effectively organize and communicate technical information
- The incumbent must have the ability to work and interact with many cultures in many time zones, and be capable of interpreting and analyzing technical data from different regions for decision making.
- Must be able to maintain a high degree of accuracy and analytical thinking.
- Minimum 7 years working experience in the food/nutritional industry and experience in the scale- up and commercialization of product innovations.
- Knowledge of HARPC principles