Accenture
Life Sciences Quality Management Systems - Management Consultant
Accenture, Chicago, Illinois, United States, 60290
Overview
Accenture's Life Science Quality practice focuses on fostering long-term client relationships, particularly on transforming the ways of working through innovation and technology, especially around complex and large-scale projects, to ensure client success. Practice members act as trusted advisors to clients and Accenture leadership on matters of quality operations, expectation management, and client business outcomes. Our Quality Delivery Framework, which includes End-to-End Client Success Management, Client Quality Methods (CQM), Client Quality Assurance (CQA), Client Quality Intervention (CQI), Client Quality Datasets (CQD), and Client Quality Continuous Improvement (CQCI), aims to support clients and client teams in achieving positive business outcomes throughout the project lifecycle. Accenture's Quality practice leverages data-driven insights and integrated governance processes to manage client delivery, identify risks early, take mitigating actions, and drive client value. As a team member of the Accenture Life Sciences Quality Practice, you will be exposed to the cutting-edge innovation, technologies and processes that many leading companies and government agencies utilize. Responsibilities
Develop, implement, and maintain quality management systems (QMS) in compliance with regulatory standards (e.g., FDA, EMA, ISO). Support internal and external audits to ensure compliance with quality standards and regulatory requirements. Provide guidance on quality assurance and control processes, including risk management, CAPA (Corrective and Preventive Actions), and change control. Collaborate with cross-functional teams to ensure quality is integrated into all aspects of product development and manufacturing. Monitor and analyze quality metrics to identify trends and areas for improvement. Prepare and review quality documentation, including SOPs (Standard Operating Procedures), validation protocols, and technical reports. Stay up-to-date with industry trends and regulatory changes to ensure ongoing compliance and continuous improvement. Play a wide variety of roles related to delivery, such as analyzing and designing new business processes, defining detailed product requirements and use cases, and serving as a liaison to the business community to maintain the business perspective; demonstrate creativity and flexibility in project plans and estimates from implementation to deployment; proactively manage and report on execution of deliverables; communicate effectively across multiple stakeholders to align priorities and direction. Assist with shaping client’s digital transformation vision, focus areas, and journey from the current state to a “to-be” enterprise environment. Develop a point-of-view on digital solutions to deliver on transformational goals along with strengths and weaknesses of various planning solutions. Collaborate with management to ensure buy-in to recommended solutions. Support delivery initiatives and the design and implementation of digital solutions, processes, and operating model by leveraging Accenture’s implementation methodology. Build and apply technical, industry, organization, and functional knowledge to support delivery efforts for clients. Qualifications
What you need: Bachelor's degree in Life Sciences, Engineering, or a related field. Minimum of 3 years of experience: Working in the Quality Domain across Quality Management, Quality Operations, Quality Control and/or Quality Assurance Quality process experience (Deviations, investigations, CAPAs, Change Control, Complaints) QMS system experience (TrackWise or Veeva) SOP/Technical writing experience Experiences with traditional and agile project/software development methodologies Strong analytical and problem-solving skills Excellent communication and interpersonal skills Ability to work independently and as part of a team Travel - candidates must be willing to travel up to 50% to client locations Bonus Points If You Have
Prior experience working for a Consulting Firm or Software Informatics firm in the space Compensation and Benefits
Compensation at Accenture varies depending on a wide array of factors, which may include but are not limited to the specific office location, role, skill set, and level of experience. As required by local law, Accenture provides a reasonable range of compensation for roles that may be hired in California, Colorado, District of Columbia, Illinois, Maryland, Minnesota, New Jersey, New York or Washington as set forth below. We accept applications on an on-going basis and there is no fixed deadline to apply. Information on benefits is here. (https://www.accenture.com/us-en/careers/local/total-rewards) Role Location Annual Salary Range California $63,800 to $205,800 Colorado $63,800 to $177,800 District of Columbia $68,000 to $189,300 Illinois $59,100 to $177,800 Minnesota $63,800 to $177,800 Maryland $63,800 to $177,800 New York/New Jersey $59,100 to $205,800 Washington $68,000 to $189,300 Accommodations and Equal Opportunity
Requesting an Accommodation: Accenture is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Accenture and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired. If you would like to be considered for employment opportunities with Accenture and have accommodation needs such as for a disability or religious observance, please call us toll free at 1 (877) 889-9009 or send us an email or speak with your recruiter. Equal Employment Opportunity Statement: We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. For details, view a copy of the Accenture Equal Employment Opportunity Statement (https://www.accenture.com/content/dam/accenture/final/accenture-com/document-3/Accenture-Equal-Employment-Opportunity-Statement.pdf#zoom=50) Accenture is an EEO and Affirmative Action Employer of Veterans/Individuals with Disabilities. Accenture is committed to providing veteran employment opportunities to our service men and women. Other Employment Statements: Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States. Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration. Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process. The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. The California privacy notice and other state notices may apply as relevant.
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Accenture's Life Science Quality practice focuses on fostering long-term client relationships, particularly on transforming the ways of working through innovation and technology, especially around complex and large-scale projects, to ensure client success. Practice members act as trusted advisors to clients and Accenture leadership on matters of quality operations, expectation management, and client business outcomes. Our Quality Delivery Framework, which includes End-to-End Client Success Management, Client Quality Methods (CQM), Client Quality Assurance (CQA), Client Quality Intervention (CQI), Client Quality Datasets (CQD), and Client Quality Continuous Improvement (CQCI), aims to support clients and client teams in achieving positive business outcomes throughout the project lifecycle. Accenture's Quality practice leverages data-driven insights and integrated governance processes to manage client delivery, identify risks early, take mitigating actions, and drive client value. As a team member of the Accenture Life Sciences Quality Practice, you will be exposed to the cutting-edge innovation, technologies and processes that many leading companies and government agencies utilize. Responsibilities
Develop, implement, and maintain quality management systems (QMS) in compliance with regulatory standards (e.g., FDA, EMA, ISO). Support internal and external audits to ensure compliance with quality standards and regulatory requirements. Provide guidance on quality assurance and control processes, including risk management, CAPA (Corrective and Preventive Actions), and change control. Collaborate with cross-functional teams to ensure quality is integrated into all aspects of product development and manufacturing. Monitor and analyze quality metrics to identify trends and areas for improvement. Prepare and review quality documentation, including SOPs (Standard Operating Procedures), validation protocols, and technical reports. Stay up-to-date with industry trends and regulatory changes to ensure ongoing compliance and continuous improvement. Play a wide variety of roles related to delivery, such as analyzing and designing new business processes, defining detailed product requirements and use cases, and serving as a liaison to the business community to maintain the business perspective; demonstrate creativity and flexibility in project plans and estimates from implementation to deployment; proactively manage and report on execution of deliverables; communicate effectively across multiple stakeholders to align priorities and direction. Assist with shaping client’s digital transformation vision, focus areas, and journey from the current state to a “to-be” enterprise environment. Develop a point-of-view on digital solutions to deliver on transformational goals along with strengths and weaknesses of various planning solutions. Collaborate with management to ensure buy-in to recommended solutions. Support delivery initiatives and the design and implementation of digital solutions, processes, and operating model by leveraging Accenture’s implementation methodology. Build and apply technical, industry, organization, and functional knowledge to support delivery efforts for clients. Qualifications
What you need: Bachelor's degree in Life Sciences, Engineering, or a related field. Minimum of 3 years of experience: Working in the Quality Domain across Quality Management, Quality Operations, Quality Control and/or Quality Assurance Quality process experience (Deviations, investigations, CAPAs, Change Control, Complaints) QMS system experience (TrackWise or Veeva) SOP/Technical writing experience Experiences with traditional and agile project/software development methodologies Strong analytical and problem-solving skills Excellent communication and interpersonal skills Ability to work independently and as part of a team Travel - candidates must be willing to travel up to 50% to client locations Bonus Points If You Have
Prior experience working for a Consulting Firm or Software Informatics firm in the space Compensation and Benefits
Compensation at Accenture varies depending on a wide array of factors, which may include but are not limited to the specific office location, role, skill set, and level of experience. As required by local law, Accenture provides a reasonable range of compensation for roles that may be hired in California, Colorado, District of Columbia, Illinois, Maryland, Minnesota, New Jersey, New York or Washington as set forth below. We accept applications on an on-going basis and there is no fixed deadline to apply. Information on benefits is here. (https://www.accenture.com/us-en/careers/local/total-rewards) Role Location Annual Salary Range California $63,800 to $205,800 Colorado $63,800 to $177,800 District of Columbia $68,000 to $189,300 Illinois $59,100 to $177,800 Minnesota $63,800 to $177,800 Maryland $63,800 to $177,800 New York/New Jersey $59,100 to $205,800 Washington $68,000 to $189,300 Accommodations and Equal Opportunity
Requesting an Accommodation: Accenture is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Accenture and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired. If you would like to be considered for employment opportunities with Accenture and have accommodation needs such as for a disability or religious observance, please call us toll free at 1 (877) 889-9009 or send us an email or speak with your recruiter. Equal Employment Opportunity Statement: We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. For details, view a copy of the Accenture Equal Employment Opportunity Statement (https://www.accenture.com/content/dam/accenture/final/accenture-com/document-3/Accenture-Equal-Employment-Opportunity-Statement.pdf#zoom=50) Accenture is an EEO and Affirmative Action Employer of Veterans/Individuals with Disabilities. Accenture is committed to providing veteran employment opportunities to our service men and women. Other Employment Statements: Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States. Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration. Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process. The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. The California privacy notice and other state notices may apply as relevant.
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