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Senior Consultant-Digital Quality & Compliance

Deloitte • Full-time • Philadelphia, Pennsylvania, United States • 5h ago

Senior Consultant-Digital Quality & Compliance

Strategy, Growth, and Transformation | Functional and Operational Strategy and Transformation

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Position Summary

Senior Consultant – Digital Quality & Compliance

Our Deloitte Regulatory, Risk & Forensic team helps client leaders translate multifaceted risk and an evolving regulatory environment into defensible actions that strengthen, protect, and transform their organization. Join our team and use advanced data, AI, and emerging technologies with industry insights to help clients bring clarity from complexity and accelerate their path to value creation.

Work you'll do

As a Senior Consultant, Strategy, Growth, and Transformation on the Regulatory, Risk & Forensic team, you will be responsible for leading validation and compliance activities for complex GxP systems across regulated technology environments.

Lead end-to-end validation activities for GxP systems, including validation plans, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) protocols, summary reports, user requirements specifications, functional specifications, design specifications, and traceability matrices
Lead computer system validation (CSV) and computerized system assurance (CSA) deliverables across the shop-floor systems lifecycle (L2 to L6), including risk assessments, validation planning, requirements traceability, test strategy and execution, deviation management, final reporting, and release approval
Apply risk-based validation principles to assess system impact, classify validation requirements, and support compliance with GAMP 5, 21 CFR Part 11, European Union Annex 11, and data integrity requirements
Drive inspection readiness activities, including gap assessments, mock audits, validation package reviews, and support for regulatory inspections and responses
Lead corrective and preventive action (CAPA) activities and support validation approaches for artificial intelligence and machine learning-enabled GxP systems and automation testing frameworks, including documentation of governance requirements for non-deterministic outputs

A successful candidate would possess these skills:

Ability to work independently and collaborate as part of a team
Effective written and verbal communication skills
Meticulous attention to detail and quality of work product
Ability to build and sustain professional relationships
Ability to lead projects or workstreams
Ability to manage and prioritize multiple tasks in a fast-paced and dynamic environment
Strong interpersonal skills and professional demeanor
Ability to meet deadlines
Ability to provide clear guidance to others

The team

Our Enterprise Operations & Risk offering enables clients to achieve profitable growth and competitive advantage by optimizing “heart of the business” operations. We leverage deep domain expertise to extend enterprise resilience, agility and remediation. Our professionals address client needs which span the organization and impact strategy, operations, performance and reputation.

Qualifications

Required:

Bachelor’s degree in business, information systems, computer science, engineering, or equivalent experience and 6+ years of experience in computer system validation in a life sciences environment, including pharmaceutical, biotechnology, medical device, or clinical environments
Experience leading validation deliverables for GxP systems and computer system validation (CSV) and computerized system assurance (CSA) activities across the shop-floor systems lifecycle (L2 to L6), including validation plans, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) protocols, summary reports, user requirements specifications, functional specifications, design specifications, traceability matrices, risk assessments, test strategy and execution, deviation management, final reporting, and release approval
Hands-on understanding of PLC/SCADA architectures, control strategies, alarms
Experience applying 21 CFR Part 11, European Union Annex 11, GAMP 5, and data integrity requirements, including Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available (ALCOA+) principles
Experience managing CAPA lifecycle activities, supporting inspection readiness for Food and Drug Administration (FDA) or European Medicines Agency (EMA) audits, and validating artificial intelligence/machine learning (AI/ML)-enabled systems or automation testing frameworks
Ability to travel 10%, on average, based on the work you do and the clients and industries/sectors you serve.
Limited immigration sponsorship may be available.

Preferred:

Experience supporting periodic review programs for validated systems and associated CAPA triggers
Experience validating cloud or software as a service platforms, including Veeva, ServiceNow, or Salesforce, in a GxP environment
Experience working in Agile delivery environments with validation activities embedded in sprints
Experience with AI governance processes, including AI use case tracking, model risk classification, and disclosure requirements for GxP systems

The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Deloitte, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range is $110,700 to $218,300.

You may also be eligible to participate in a discretionary annual incentive program, subject to the rules governing the program, whereby an award, if any, depends on various factors, including, without limitation, individual and organizational performance.

Deloitte is committed to providing reasonable accommodations for people with disabilities. If you require a reasonable accommodation to participate in the recruiting process, please direct your inquiries to the Global Call Center (GCC) at USTalentCICInbox@deloitte.com.

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Our people and culture

Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ways of thinking, ideas, and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work.

Our purpose

Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Learn more.

Professional development

From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.

As used in this posting, "Deloitte" means Deloitte & Touche LLP, a subsidiary of Deloitte LLP. Please see www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. Certain services may not be available to attest clients under the rules and regulations of public accounting.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or protected veteran status, or any other legally protected basis, in accordance with applicable law.

Requisition code: 362643

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