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Accenture · 1 day ago

Life Sciences Quality Management Systems - Management Consultant - Manager

New York, NY

Full-time

Hybrid

Mid Level

$64K/yr - $206K/yr

3+ years exp

Accenture's Life Sciences Quality practice focuses on fostering long-term client relationships through innovation and technology. The role involves developing and maintaining quality management systems, supporting compliance with regulatory requirements, and providing guidance on quality-related matters.

Business Information SystemsConstructionConsultingInformation ServicesInformation TechnologyInfrastructureManagement ConsultingOutsourcing

No H1B

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

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

Qualification

Quality Management SystemsRegulatory ComplianceQuality AssuranceQMS System ExperienceAnalytical SkillsTechnical WritingProject ManagementCommunication SkillsInterpersonal SkillsProblem-Solving Skills

Required

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