Job description

Senior 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 with industry insights to help clients bring clarity from complexity and accelerate their path to value creation Work You’ll Do The Senior Consultant is responsible for helping to deliver related client projects, and in doing so to continue to grow professionally in the areas of subject matter expertise and consulting engagement administration. A Senior Consultant must understand how Commercial and Medical activities and related messaging/content are influenced by Regulatory/Health Authority requirements. This could include: • 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 (e.g., compliance history, inspection readiness, quality system maturity) • 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 (e.g., SOPs, training, deviation management, corrective and preventive actions (CAPA), change control, complaints) • Support inspection readiness planning and execution (e.g., mock inspections, observation response planning, compliance remediation roadmaps) • Help design and implement RA/QA technology enablement, including requirements definition, vendor selection support, process design, testing/validation coordination, and deployment/adoption planning • Support implementation and optimization of systems such as electronic QMS (eQMS), document management systems (DMS), learning management systems (LMS), complaint handling, CAPA, change control, audit management, supplier quality, and regulatory information management (RIM) platforms • Develop client-ready deliverables (assessments, workflows, requirements, business cases, implementation plans, and executive communications) and manage workstream risks, dependencies, and stakeholder alignment • Additional expectation is to continually build detailed subject matter expertise and assist in the buildout of service offerings in the area of Commercial and Medical Content Management 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 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 (e.g., automation, analytics, decision support) • 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 (tailor to your target market) • 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 (e.g., remediation cost, timeline, supply risk, launch/approval risk) • 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 • 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. 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 Preferred: • 3+ years of experience in the Pharmaceutical, Biotech and/or Medical Device industries Information for applicants with a need for accommodation: www2.deloitte.com 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 $110700- $218300. 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.

Requirements

Must-haves

Senior Consultant – Product Quality & Safety - Life Sciences & Healthcare
Enterprise Operations & Risk
Work You’ll Do
Support clients in pharmaceutical and medical device Regulatory Affairs and Quality Assurance strategy, operating model, process, and governance improvements
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 (e.g., SOPs, training, deviation management, corrective and preventive actions (CAPA), change control, complaints)
Support inspection readiness planning and execution (e.g., mock inspections, observation response planning, compliance remediation roadmaps)
Help design and implement RA/QA technology enablement, including requirements definition, vendor selection support, process design, testing/validation coordination, and deployment/adoption planning
Develop client-ready deliverables (assessments, workflows, requirements, business cases, implementation plans, and executive communications) and manage workstream risks, dependencies, and stakeholder alignment
Additional expectation is to continually build detailed subject matter expertise and assist in the buildout of service offerings in the area of Commercial and Medical Content Management
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 (e.g., automation, analytics, decision support)
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 (tailor to your target market)
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 (e.g., remediation cost, timeline, supply risk, launch/approval risk)
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

Nice-to-haves

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Keywords to mirror

aigo

Platform: avature
Effort: medium