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USA - QA Manager QMS Support

Spectraforce

Millburn, New Jersey


8 months ago

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USA - QA Manager QMS Support
Spectraforce
Millburn, New Jersey

8 months ago

Job Description

We are seeking a highly skilled and motivated Business Consultant to join our Quality Assurance Department within Novartis Radioligand Therapies (RLT). As a Business Consultant, you will be responsible for leading multiple Quality Management integrations within the organization. Your primary focus will be on two key projects: the adoption of a Document Management System and the execution of change management records for process and quality management system adoption.Key Responsibilities:Lead and support the adoption of a Document Management System (DMS) within RLT.Collaborate with cross-functional teams to assess the current document management processes and systems.Execute the strategy and detailed project plan for the implementation of the new DMS, including timelines and deliverables.Facilitate the migration of documents from the existing system to the new DMS, ensuring data integrity and compliance.Develop and execute change management strategies to ensure smooth adoption of the new DMS.Provide training and support to employees and stakeholders on the use of the new DMS.Monitor and evaluate the effectiveness of the new DMS and identify opportunities for continuous improvement.Create, manage, and execute change management records in the change management system.Collaborate with cross-functional teams to identify process and quality management system changes.Develop a comprehensive change management plan, including communication strategies, training plans, and stakeholder engagement.Execute the change management plan, ensuring adherence to timelines and deliverables.Monitor and evaluate the effectiveness of the change management process and make recommendations for improvement.Provide guidance and support to cross-functional teams during the execution of change management activities.Ensure compliance with regulatory standards and industry best practices during the change management process.Support additional QMS integration activities as required.Key Skills and Qualifications:Bachelor's/advanced degree in a relevant field such as Business Administration, Quality Management, or Pharmaceutical Sciences. Certification in Compliance or Quality Assurance preferred.Previous working knowledge of the Novartis landscape.Proven experience as a Business Consultant or in a similar role, preferably within the pharmaceutical industry.Strong understanding of quality management principles, regulations, and standards, including FDA regulations and Good Manufacturing Practices (GMP).Excellent project management skills, with the ability to manage multiple projects simultaneously and meet deadlines.Solid analytical and problem-solving skills, with the ability to identify root causes and develop effective solutions.Excellent communication and interpersonal skills, with the ability to collaborate and influence cross-functional teams.Proficiency in using quality management tools and methodologies, such as Six Sigma, Lean, or Kaizen.Experience managing, deploying non-IT tools and technologies commonly used in quality management, such as document management systems, change management systems, and electronic document management systems (EDMS).Projects:Adoption of a Document Management System (DMS): The Business Consultant will lead the implementation of a new DMS to streamline document management processes and ensure compliance with regulatory standards. This project may involve assessing current processes, implementing existing strategy and plans to the new system, migrating documents, and facilitating change management activities.Change Management for Process and Quality Management System Adoption: The Business Consultant will be responsible for creating, managing, and executing change management records in the change management system. This includes collaborating with cross-functional teams, developing and executing change management plans, and ensuring compliance with regulatory standards and industry best practices.Milestones:Completion of the assessment of current document management processes and systems.Execution of the existing strategy and detailed project plan for the adoption of the new DMS.Successful migration of documents from the existing system to the new DMS, ensuring data integrity and compliance.Execution of change management activities according to the change management plan.Evaluation and documentation of the effectiveness of the new DMS and change management process.Continuous monitoring and improvement of document management processes and change management activities based on feedback and performance metrics. 

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: $9.50/daily.