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

About the role

The Senior Consultant is responsible for delivering related client projects, 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 Pharmaceutical and Medical Device Regulatory Affairs and Quality Assurance strategy, operating model, process, and governance improvements.
• Conduct quality and regulatory due diligence for mergers & acquisitions (M&A), including risk identification, evidence requests, and diligence readouts.
• Support separation and integration activities for QA/RA, including Day 1 readiness, target operating model, transition service agreement (TSA) considerations, and cutover planning.
• Assess and remediate quality management system (QMS) and regulatory compliance gaps.
• Support inspection readiness planning and execution.
• Help design and implement RA/QA technology enablement.
• Support implementation and optimization of systems such as eQMS, DMS, LMS, complaint handling, CAPA, change control, audit management, supplier quality, and RIM platforms.
• Develop client-ready deliverables and manage workstream risks, dependencies, and stakeholder alignment.
• Build detailed subject matter expertise and assist in the buildout of service offerings in the area of Commercial and Medical Content Management.

Requirements

Required:

• 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., Good Manufacturing Practice (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 (planning, data room requests, interviews, risk rating, and diligence reporting).
• Experience supporting separation and integration for QA/RA functions (process and system disentanglement, integration design, governance, TSA planning, and cutover execution).
• Ability to identify and quantify quality/regulatory risks that impact deal value.
• Experience implementing or optimizing quality and regulatory systems, including requirements gathering, future-state process design, validation approach coordination, testing, training, and go-live support.
• 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 (e.g., dashboards, KPIs, traceability, audit trails), including adoption and sustainment planning.
• 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:

• 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., Good Manufacturing Practice (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 (planning, data room requests, interviews, risk rating, and diligence reporting).
• Experience supporting separation and integration for QA/RA functions (process and system disentanglement, integration design, governance, TSA planning, and cutover execution).
• Ability to identify and quantify quality/regulatory risks that impact deal value.
• Experience implementing or optimizing quality and regulatory systems, including requirements gathering, future-state process design, validation approach coordination, testing, training, and go-live support.
• 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 (e.g., dashboards, KPIs, traceability, audit trails), including adoption and sustainment planning.
• 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

Preferred:

• 3+ years of experience in the Pharmaceutical, Biotech and/or Medical Device industries.

Benefits

Not specified.

Pay

$110,700 - $218,300

Schedule

Not specified.