Life Sciences Quality Management Systems - Management Consultant - Manager at Accenture

New York, New York, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Pharmaceuticals, Biotechnology, Medical Devices, ConsultingIndustries

Requirements

Strong background in quality management within the life sciences industry, including pharmaceuticals, biotechnology, and medical devices
Experience supporting compliance with regulatory requirements (e.g., FDA, EMA, ISO)
Knowledge of quality assurance and control processes, including risk management, CAPA (Corrective and Preventive Actions), and change control
Ability to stay up-to-date with industry trends and regulatory changes

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, 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, validation protocols, and technical reports
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, estimates, scope, and requirements from implementation to deployment
Proactively manage and report on execution of deliverables
Communicate effectively across multiple stakeholders, aligning priorities and direction
Assist with shaping client’s digital transformation vision, focus areas, and journey from current state to a “to-be” enterprise environment
Develop a point-of-view on digital solutions to deliver on transformational goals, including 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

Skills

Key technologies and capabilities for this role

Quality Management SystemsRegulatory ComplianceLife SciencesPharmaceuticalsBiotechnologyMedical DevicesClient DeliveryQuality AssuranceRisk ManagementGovernance ProcessesContinuous Improvement

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require office work?

This information is not specified in the job description.

What key skills and experiences are required for this role?

The role requires a strong background in quality management within life sciences (pharmaceuticals, biotechnology, medical devices), expertise in developing and maintaining QMS compliant with FDA, EMA, ISO standards, experience with audits, CAPA, risk management, change control, and analyzing quality metrics.

What is the company culture like in Accenture's Life Sciences Quality practice?

The practice focuses on fostering long-term client relationships, acting as trusted advisors, leveraging innovation, technology, data-driven insights, and integrated governance to drive client success and positive business outcomes.

What makes a strong candidate for this Quality Consultant role?

A strong candidate has deep life sciences quality management experience, regulatory compliance expertise (FDA, EMA, ISO), skills in QMS development, audits, CAPA, risk management, and the ability to collaborate cross-functionally while staying current on industry trends.

Accenture

Global professional services for digital transformation

About Accenture

Accenture provides a wide range of professional services, including strategy and consulting, technology, and operations, to help organizations improve their performance. Their services assist clients in navigating digital transformation, enhancing operational efficiency, and achieving sustainable growth. Accenture's offerings include cloud migration, cybersecurity, artificial intelligence, and data analytics, which are tailored to meet the needs of various industries such as financial services, healthcare, and retail. What sets Accenture apart from its competitors is its extensive industry knowledge and ability to deliver comprehensive solutions that address both immediate challenges and long-term goals. The company's aim is to support clients in reducing their environmental impact while driving innovation and growth.

Dublin, IrelandHeadquarters

1989Year Founded

$8.5MTotal Funding

IPOCompany Stage

Consulting, Enterprise Software, CybersecurityIndustries

10,001+Employees

Risks

Rapid AI advancements may outpace Accenture's current capabilities, risking competitive disadvantages.

Integration challenges from multiple acquisitions could affect Accenture's operational efficiency.

The rise of AI-driven startups may disrupt Accenture's market share in customer service solutions.

Differentiation

Accenture's acquisitions enhance its capabilities in digital twin technology for financial services.

The company is expanding its expertise in net-zero infrastructure through strategic acquisitions.

Accenture's focus on software-defined vehicles positions it as a leader in automotive innovation.

Upsides

Accenture's investment in EMTECH supports central bank modernization amid digital currency evolution.

The acquisition of Award Solutions boosts Accenture's presence in the growing 5G and IoT markets.

Accenture's strategic acquisitions align with high-growth markets like digital twins and net-zero projects.

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