• Job title: Project Manager, Quality Assurance
• Duration: 12 months
• Location: North Chicago IL 60064

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:

• 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

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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

 

 

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
 
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
 
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer. 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $50.00/hr.