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Life Sciences Quality Management Systems - Management Consultant - Manager

Life Sciences Quality Management Systems - Management Consultant - Manager

Boston StaffingBoston, MA, US
3 days ago
Job type
  • Full-time
Job description

Life Sciences Quality Consultant

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.

We are seeking a highly skilled and experienced Life Sciences Quality Consultant to join our team. Consultants are the driving force for client delivery, working closely with project management and analysts to realize value on delivery engagements, as well as with leadership to identify and address new challenges our clients face. The ideal candidate will have a strong background in quality management within the life sciences industry, including pharmaceuticals, biotechnology, and medical devices. The consultant will be responsible for supporting compliance with regulatory requirements, improving quality systems, and providing subject matter guidance on quality-related matters.

Responsibilities include :

  • 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

Additionally, a Quality Consultant will play a wide variety of roles related to delivery, such as :

  • Analyze and design new business processes
  • Identify and define detailed product requirements and use cases
  • Serve as a liaison to the business community and participate in user and task analysis to maintain the business community's perspective
  • Demonstrate creativity and flexibility when creating and driving project plans and estimates, scope and requirements from implementation to deployment
  • Proactively manage and report on execution of deliverables
  • Master communicators across multiple stakeholders aligning 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
  • Here's 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 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.

    We accept applications on an ongoing basis and there is no fixed deadline to apply. Information on benefits is here.

    Role location annual salary range :

  • California $63,800 to $205,800
  • Cleveland $59,100 to $164,600
  • Colorado $63,800 to $177,800
  • District of Columbia $68,000 to $189,300
  • Illinois $59,100 to $177,800
  • Maryland $63,800 to $177,800
  • Massachusetts $63,800 to $189,300
  • Minnesota $63,800 to $177,800
  • New York / New Jersey $59,100 to $205,800
  • Washington $68,000 to $189,300
  • 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 Opportunity Statement.

    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 any 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. Further, at Accenture a criminal conviction history is not an absolute bar to employment. 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. Additionally, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the Companys legal duty to furnish information. California requires additional notifications for applicants and employees. If you are a California resident, live in or plan to work from Los

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