Job Description

Job Title: Supply Chain Quality Assurance Manager

Location: North Chicago, IL 60085-Hybrid

Duration: 10 months (Possible extension)

Minimum Rate : $50 an hour

Description:

Work Schedule – Hybrid 3 onsite/2 remote – This is subject to change so the worker must be flexible. Normal business hours. No OT required.

Describe the primary goals, objectives or functions or outputs of this position.

• 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 to successfully deliver objectives.
• Provides regular updates and recommendations to senior leadership to drive an effective Quality System.

Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

•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

.

Qualifications:

List required and preferred qualifications (up to 10). Include education, skills and experience.

•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.

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