Global Supply Chain QA Project Manager - North Chicago, IL

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

Job Description

Leads global projects and/or programs which support various strategic initiatives within the Quality System. Responsibilities include all aspects of end-to-end project and/or program management within specific area of expertise. Actively collaborates with manufacturing sites, external manufacturing, regulatory, supply chain, product quality, compliance, and other global functions in order to successfully deliver objectives. Provides regular updates and recommendations to senior leadership in order to drive an effective Quality System.

Responsibilities

Develops project timelines, deliverables, conducts research analysis, monitors project status, and provides expertise for global projects/programs supporting strategic global Quality initiatives
Actively collaborates with cross-functional team to complete project milestones per established timeline. Leads meetings with cross-functional partners.
Utilizes expertise within GxP to review various types of content, such as external regulations or governing documents, and provide recommendations.
May create and manage project/program tasks within quality software system.
Builds and maintains collaborative partnerships with cross-functional stakeholders at all levels of the organization to understand business needs and incorporate these into assigned project/program decisions.
Manages end-to-end lifecycle of project/program, including driving team accountability, addressing project risks, driving effective decision making.
Creates and continuously improves meaningful metrics to demonstrate effectiveness and performance of assigned project/program.
Monitors changes in external regulations and project manages changes to internal processes accordingly.
Effectively delivers project or program status updates and recommendations for future strategic initiatives to senior leadership

Additional Qualifications/Responsibilities

Qualifications

Bachelor's degree in Science/Engineering/Business Management or equivalent technical work experience
5+ years of relevant Quality experience in a GMP pharmaceutical, biologics, and/or medical device manufacturing environment
Strong understanding of cGxPs, regulatory inspections, regulatory documents, global regulations, and standards
Experience in Project Management and leading cross-functional project teams with technical professionals in a global and/or complex, matrixed organization
Strong oral and written communication, interpersonal, time management, influence, and problem-solving skills
Proficient in the use of standard software applications including Office 365
Validation experience with equipment, facility, utilities and/or process validation

Pay Range: $

96500 - 183500 USD