Sr. Project Manager, Product Quality Assurance

Position Summary

Responsible for project management for the Product Quality Assurance (PQA) department including the facilitation of integrating PQA’s QMS processes associated with complaint handling, post market surveillance and field corrective action prior to and/or associated with the One Quality Management System / Electronic Quality Management System (1/eQMS) Program. Accountable for planning, tracking, budget preparation and stakeholder communications throughout project lifecycles.

Principal Responsibilities

•    Partner with Product Quality Assurance peers to determine which initiatives and QMS process integrations require project management governance per company and Global QARA guidelines 
•    Develop, plan, communicate and track overall project schedule and individual workstream project schedules and budget
•    Facilitate project meetings to ensure project phase deliverables and milestones are achieved; ensure strong documentation of project plans, schedules, metrics, and status reports including meeting minutes with action items and follow up with SMEs on expected deliverables
•    Collaborate with other project teams, CAPA coordinators, change control owners and/or workstream/shared services leads, as well as impacted functional leaders (e.g. regulatory, quality, clinical, finance, R&D and operations), to ensure efficient execution and minimize disruption
•    Partner with 1/eQMS workstream leads and teams regarding deliverables and progress to ensure a harmonized approach for achieving process and system compliance. Negotiate solutions and/or resolve conflicts as needed to progress deliverables.
•    Communicate effectively with PQA and Global QARA leadership to ensure clear expectations, demonstrate progress and identify issues 
•    Provide progress updates and regular reporting to business and functional leadership
•    Support and/or participate in project tasks as needed to ensure deliverables and milestones are accomplished; facilitate workshops, process mapping, organize action items, and modify documents
•    Provide oversight and support of QMS process improvements and change management under the project to ensure efficient and consistent process and procedural updates
 

Education / Experience Requirements

•    Bachelor’s degree in a business or science discipline or equivalent education/experience required.
•    Minimum 5 years project management experience in large organizations with national or global operations, with at least 2 being in an FDA regulated industry.
•    PMP Certification preferred.
•    Knowledge and application of a disciplined project management process.
•    Six Sigma certification is a plus.
•    Familiarity with electronic Quality Systems desired (e.g. Pilgrim, Agile, SAP, Veeva).
 

Specialized Skills / Other Requirements

•    Must have project management and process improvement skills
•    Strong influence management skills. Demonstrated ability to work cooperatively at all levels in a matrix organization to build and maintain the positive relationships required to accomplish project goals
•    Excellent verbal/ written communication and presentation skills. Demonstrated ability to succinctly and accurately communicate to various levels of management and across the organization
•    Ability to support multiple projects and balance priorities, work independently or collaboratively to determine and develop solutions
•    MS Project or equivalent, Excel, PowerPoint and SharePoint skills
•    Exceptional facilitation, analytical, planning, organization and time management skills to effectively execute project plans
•    Excellent decision-making skills. Ability to negotiate and balance decisions and manage competing priorities across multiple functional areas