Life Sciences Quality Management Systems - Management 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.

What would you do?

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.

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. 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

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