Senior Consultant - Product Quality & Safety - Life Sciences & Healthcare

About the role

The Senior Consultant is responsible for delivering related client projects and growing professionally in areas of subject matter expertise and consulting engagement administration. Key responsibilities include:

• Supporting clients in Regulatory Affairs and Quality Assurance strategy, operating model, process, and governance improvements.
• Conducting quality and regulatory due diligence for mergers & acquisitions (M&A), including risk identification, evidence requests, and diligence readouts.
• Assessing and remediating quality management system (QMS) and regulatory compliance gaps.
• Supporting inspection readiness planning and execution.
• Helping design and implement RA/QA technology enablement.
• Supporting implementation and optimization of systems such as eQMS, DMS, LMS, complaint handling, CAPA, change control, audit management, supplier quality, and RIM platforms.
• Developing client-ready deliverables and managing workstream risks, dependencies, and stakeholder alignment.
• Building detailed subject matter expertise and assisting in the buildout of service offerings in the area of Commercial and Medical Content Management.

Responsibilities

The Senior Consultant will support clients in the following areas:

• Pharmaceutical and Medical Device Regulatory Affairs and Quality Assurance strategy, operating model, process, and governance improvements.
• Mergers & Acquisitions (M&A) due diligence focused on QA/RA, including planning, data room requests, interviews, risk rating, and diligence reporting.
• Separation and integration activities for QA/RA functions, including process and system disentanglement, integration design, governance, TSA planning, and cutover execution.
• Assessment and remediation of quality management system (QMS) and regulatory compliance gaps.
• Inspection readiness planning and execution, including mock inspections, observation response planning, and compliance remediation roadmaps.
• Technology enablement, including requirements definition, vendor selection support, process design, testing/validation coordination, and deployment/adoption planning.
• Implementation and optimization of systems such as eQMS, DMS, LMS, complaint handling, CAPA, change control, audit management, supplier quality, and RIM platforms.
• Development of client-ready deliverables, including assessments, workflows, requirements, business cases, implementation plans, and executive communications.
• Leading/mentoring a cross-functional team of government program consultants.

Requirements

Required qualifications include:

• Bachelor’s degree required.
• 5+ years of experience with a focus on Life Sciences in a Consulting or Industry role.
• Experience in the application of artificial intelligence (AI) tools and techniques to deliver measurable business outcomes.
• Experience in pharmaceutical QA/RA (e.g., GMP, quality systems, compliance remediation) and/or medical device QA/RA (e.g., design controls, risk management, post-market processes).
• Working knowledge of common regulatory/quality expectations and frameworks applicable to pharma and devices.
• Experience translating regulatory/quality requirements into operational processes, controls, and measurable performance metrics.
• Experience supporting M&A due diligence focused on QA/RA.
• Experience supporting separation and integration for QA/RA functions.
• Ability to identify and quantify quality/regulatory risks that impact deal value.
• Experience implementing or optimizing quality and regulatory systems.
• Familiarity with eQMS and RIM capabilities such as document control, training, deviations, CAPA, change control, audits, complaints, supplier quality, and submission/product registration data management.
• Experience with data and reporting for QA/RA.
• Experience in Project Management.
• Experience working in a mandated deadline environment and ability to work effectively on multiple client assignments.
• High accuracy rate and attention to detail; ability to produce client-ready deliverables to a high-level executive/professional client base.
• Experience leading/mentoring a cross-functional team of government program consultants.

Qualifications

Required qualifications include:

• Bachelor’s degree required.
• 5+ years of experience with a focus on Life Sciences in a Consulting or Industry role.
• Experience in the application of artificial intelligence (AI) tools and techniques to deliver measurable business outcomes.
• Experience in pharmaceutical QA/RA (e.g., GMP, quality systems, compliance remediation) and/or medical device QA/RA (e.g., design controls, risk management, post-market processes).
• Working knowledge of common regulatory/quality expectations and frameworks applicable to pharma and devices.
• Experience translating regulatory/quality requirements into operational processes, controls, and measurable performance metrics.
• Experience supporting M&A due diligence focused on QA/RA.
• Experience supporting separation and integration for QA/RA functions.
• Ability to identify and quantify quality/regulatory risks that impact deal value.
• Experience implementing or optimizing quality and regulatory systems.
• Familiarity with eQMS and RIM capabilities such as document control, training, deviations, CAPA, change control, audits, complaints, supplier quality, and submission/product registration data management.
• Experience with data and reporting for QA/RA.
• Experience in Project Management.
• Experience working in a mandated deadline environment and ability to work effectively on multiple client assignments.
• High accuracy rate and attention to detail; ability to produce client-ready deliverables to a high-level executive/professional client base.
• Experience leading/mentoring a cross-functional team of government program consultants.

Skills

The successful candidate would possess the following 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.

Benefits

Deloitte offers a comprehensive benefits package, including:

• Discretionary annual incentive program.
• Professional development opportunities.
• Inclusive culture that values diversity and promotes employee growth.
• Flexible work arrangements.
• Competitive compensation and benefits package.

Pay

$110,700 - $218,300 annually.

Schedule

Full-time position with the possibility of remote work.