Abbott Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
The position of Sr. Project Manager, Toxicology is within our Toxicology business unit located in Abingdon, UK. This role will lead the development and commercialization of point of care products with integrated healthcare and information systems that assist in the detection and management of drugs of abuse.
This role also:
· Entails managing the global product development process requirements, standards implementation, and governance of new or existing programs within the Toxicology Business Unit (BU)
· Leads one or more systems development projects at varying complexities, facilitating design control and project management processes within the core teams within the approved Tox portfolio
· Coordinates, enforces, and demonstrates at the sub-system level, adherence to the product or system level criteria for successful integration into the supported corporate platform(s)
· Drives key initiatives in the Program Management Office to strengthen and improve efficiencies across projects
This job description will be reviewed periodically and is subject to change by management.
· Provides program management expertise for medium to large scale programs.
o Leads a multi-functional core team from Concept through Launch; through proper execution of Design Controls that includes efficient transfer of product from Global R&D to manufacturing and global marketing through post release to achieve project closure.
o Works closely with various disciplines within R&D and Marketing, Clinical, Quality, Regulatory, Manufacturing, and establishes program plans and objectives.
o Develops cost analysis, creates and manages the integration of project schedules, program budget.
o With the enterprise organizations, resolves resource allocation issues, conflicts, and priorities to ensure the program is staffed appropriately, completed on time, and within budget constraints.
o Tracks progress and communicates proactively the impact of changes (e.g. scope, cross functional resources, timelines, costs, etc.) to key stakeholders.
o Ensure that teams are equipped and prepared per the appropriate phase requirements to present at key business and design review meetings; that all appropriate stakeholders within and outside the BU are apprised of review meetings and the results thereof.
· Manage the process for device integration acceptance into the corporate platform(s).
o Ensures that CTQ's (Critical to Quality) and KP1V's (Key Process Input Variables) are well defined, reviewed and implemented for all projects within the program.
o Ensures that Design Reviews for system readiness include all appropriate stakeholders outside of the sub-system or individual device.
o Ensures that the Acceptance criteria for system level integration are completely aligned with the design and project management requirements for integration. Facilitate team process needed to meet requirements to demonstrate system level integration readiness.
o Ensures the timely collaboration and coordination of design requirements, cross functional resourcing, and scheduling between projects, sites, and platform/system level organizations.
o Ensure system level compliance and enforce quality practices (e.g. facilitate Design Reviews, Key Lemmings, etc.).
· Provides data to support the publication of the BU's monthly project dashboards and messaging.
· Leads the teams through best practices in planning such as scrum, creating work breakdowns, schedule development, and critical chain analysis
· Provide training or mentorship to other project leaders to elevate efficiencies and facilitate compliance to the Product Development and Design Change Processes
MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:
· Requires a minimum of a Bachelor's degree in Engineering, Science; or the equivalent work experience.
· Minimum of 3-5 years Project Management experience in leading medium to large size projects in the IVD or medical device industry.
· Minimum of 5 years work experience in scientific field
· PMP Certification or similar certification required
· Requires experience managing multiple product development products from inception to global commercialization using a phase-gate methodology
· Demonstrate organizational and leadership skills necessary to integrate several cross-functional departments toward company objectives.
· Demonstrated administrative, written and verbal communication, negotiation and influencing skills.
· Proficient in MS-Office, Visio, Work Breakdown tools and software
· Experienced in creating and delivering presentations to senior management
· Experience with leading product development system projects having multiple components such as software, hardware, assay, human factors
· Experience in the practical implementation of regulatory requirements for medical device development such as FDA's Design Controls, ISO's Risk Management and Medical Device standards, ISO Software Development standards, CLIA
· Highly organized
· Detail oriented
· Team player
· Effective communication and listening skills
· Focuses on Customers
· Driven for Results
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce