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Consultant - Product Quality & Safety - Life Sciences & Healthcare

Enterprise Operations & Risk

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 organizations. Join our team and use advanced data, AI, and emerging technologies-combined with industry insight-to help clients bring clarity from complexity and accelerate their path to value creation.

Work You'll Do

As a Consultant, you will support the delivery of client projects while continuing to grow your subject matter expertise and consulting skills. You will work with teams helping life sciences clients address quality, regulatory, operational, and technology-related challenges across pharmaceutical, biotech, and medical device environments. This could include:

• Support clients in pharmaceutical and medical device Regulatory Affairs and Quality Assurance strategy, process, operating model, and governance improvements
• Assist with quality and regulatory due diligence for mergers and acquisitions, including document review, evidence gathering, interview support, risk tracking, and diligence summaries
• Support separation and integration activities for QA/RA functions, including Day 1 planning, governance coordination, TSA support, and cutover readiness activities
• Help assess quality management system and regulatory compliance gaps across areas such as SOPs, training, deviation management, CAPA, change control, complaints, and audit readiness
• Support inspection readiness efforts, including mock inspection preparation, issue tracking, and remediation planning support
• Assist with QA/RA technology enablement efforts, including business requirements gathering, process documentation, test script development, validation support, training coordination, and deployment activities
• Support implementation and optimization of systems such as eQMS, document management systems, learning management systems, complaint handling, CAPA, change control, audit management, supplier quality, and regulatory information management platforms
• Develop portions of client-ready deliverables, including assessments, process flows, requirements, status reports, business cases, and implementation plans
• Track project activities, risks, dependencies, and action items, and support stakeholder coordination across workstreams
• Continue building subject matter knowledge in Regulatory Affairs, Quality Assurance, and Commercial/Medical Content Management

The 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

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

Qualifications

Required:

• Bachelor's degree required
• 2+ years of experience focused on Life Sciences in a consulting and/or industry role
• Experience or exposure to the use of data, analytics, and/or AI-enabled tools to support business processes or decision-making
• Foundational experience in pharmaceutical QA/RA (e.g., GMP, quality systems, compliance support) and/or medical device QA/RA (e.g., design controls, risk management, post-market processes)
• Working knowledge of common regulatory and quality requirements applicable to pharmaceutical and/or medical device organizations
• Experience supporting the translation of regulatory and quality requirements into business processes, documentation, or controls
• Experience supporting project delivery in areas such as compliance remediation, process improvement, system implementation, diligence, or integration planning
• Familiarity with quality and regulatory systems and capabilities such as document control, training, deviations, CAPA, change control, audits, complaints, supplier quality, and/or submission or product registration data management
• Experience supporting data analysis, reporting, dashboards, KPI tracking, or process monitoring
• Experience in project management, PMO support, or workstream coordination
• Ability to manage multiple assignments and work effectively in a deadline-driven environment
• Strong attention to detail and ability to produce polished, client-ready deliverables
• Strong written and verbal communication skills and ability to work effectively in cross-functional teams
• Must be legally authorized to work in the United States without the need for employer sponsorship, now or at any time in the future
• Ability to travel up to 50%, based on the work you do and the clients and industries/sectors you serve

• Experience in the pharmaceutical, biotech, and/or medical device industries
• Experience supporting eQMS, RIM, DMS, LMS, or related quality/regulatory technology initiatives
• Experience with compliance assessments, inspection readiness, remediation, or QA/RA process improvement

Information for applicants with a need for accommodation: https://www2.deloitte.com/us/en/pages/careers/articles/join-deloitte-assistance-for-disabled-applicants.html

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 $88700 - $170900.

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 fac tors, including, without limitation, individual and organizational performance.

Consultant - Product Quality & Safety - Life Sciences & Healthcare

Enterprise Operations & Risk

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 organizations. Join our team and use advanced data, AI, and emerging technologies-combined with industry insight-to help clients bring clarity from complexity and accelerate their path to value creation.

Work You'll Do

As a Consultant, you will support the delivery of client projects while continuing to grow your subject matter expertise and consulting skills. You will work with teams helping life sciences clients address quality, regulatory, operational, and technology-related challenges across pharmaceutical, biotech, and medical device environments. This could include:

• Support clients in pharmaceutical and medical device Regulatory Affairs and Quality Assurance strategy, process, operating model, and governance improvements
• Assist with quality and regulatory due diligence for mergers and acquisitions, including document review, evidence gathering, interview support, risk tracking, and diligence summaries
• Support separation and integration activities for QA/RA functions, including Day 1 planning, governance coordination, TSA support, and cutover readiness activities
• Help assess quality management system and regulatory compliance gaps across areas such as SOPs, training, deviation management, CAPA, change control, complaints, and audit readiness
• Support inspection readiness efforts, including mock inspection preparation, issue tracking, and remediation planning support
• Assist with QA/RA technology enablement efforts, including business requirements gathering, process documentation, test script development, validation support, training coordination, and deployment activities
• Support implementation and optimization of systems such as eQMS, document management systems, learning management systems, complaint handling, CAPA, change control, audit management, supplier quality, and regulatory information management platforms
• Develop portions of client-ready deliverables, including assessments, process flows, requirements, status reports, business cases, and implementation plans
• Track project activities, risks, dependencies, and action items, and support stakeholder coordination across workstreams
• Continue building subject matter knowledge in Regulatory Affairs, Quality Assurance, and Commercial/Medical Content Management

The 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

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

Qualifications

Required:

• Bachelor's degree required
• 2+ years of experience focused on Life Sciences in a consulting and/or industry role
• Experience or exposure to the use of data, analytics, and/or AI-enabled tools to support business processes or decision-making
• Foundational experience in pharmaceutical QA/RA (e.g., GMP, quality systems, compliance support) and/or medical device QA/RA (e.g., design controls, risk management, post-market processes)
• Working knowledge of common regulatory and quality requirements applicable to pharmaceutical and/or medical device organizations
• Experience supporting the translation of regulatory and quality requirements into business processes, documentation, or controls
• Experience supporting project delivery in areas such as compliance remediation, process improvement, system implementation, diligence, or integration planning
• Familiarity with quality and regulatory systems and capabilities such as document control, training, deviations, CAPA, change control, audits, complaints, supplier quality, and/or submission or product registration data management
• Experience supporting data analysis, reporting, dashboards, KPI tracking, or process monitoring
• Experience in project management, PMO support, or workstream coordination
• Ability to manage multiple assignments and work effectively in a deadline-driven environment
• Strong attention to detail and ability to produce polished, client-ready deliverables
• Strong written and verbal communication skills and ability to work effectively in cross-functional teams
• Must be legally authorized to work in the United States without the need for employer sponsorship, now or at any time in the future
• Ability to travel up to 50%, based on the work you do and the clients and industries/sectors you serve

• Experience in the pharmaceutical, biotech, and/or medical device industries
• Experience supporting eQMS, RIM, DMS, LMS, or related quality/regulatory technology initiatives
• Experience with compliance assessments, inspection readiness, remediation, or QA/RA process improvement

Information for applicants with a need for accommodation: https://www2.deloitte.com/us/en/pages/careers/articles/join-deloitte-assistance-for-disabled-applicants.html

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 $88700 - $170900.

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 fac tors, including, without limitation, individual and organizational performance.