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Consultant - Product Quality & Safety - Life Sciences & Healthcare

$88.7k - $170.9k

Deloitte

Position Summary 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 improvementsAssist with quality and regulatory due diligence for mergers and acquisitions, including document review, evidence gathering, interview support, risk tracking, and diligence summariesSupport separation and integration activities for QA/RA functions, including Day 1 planning, governance coordination, TSA support, and cutover readiness activitiesHelp assess quality management system and regulatory compliance gaps across areas such as SOPs, training, deviation management, CAPA, change control, complaints, and audit readinessSupport inspection readiness efforts, including mock inspection preparation, issue tracking, and remediation planning supportAssist with QA/RA technology enablement efforts, including business requirements gathering, process documentation, test script development, validation support, training coordination, and deployment activitiesSupport 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 platformsDevelop portions of client-ready deliverables, including assessments, process flows, requirements, status reports, business cases, and implementation plansTrack project activities, risks, dependencies, and action items, and support stakeholder coordination across workstreamsContinue 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 The Team 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 required2+ years of experience focused on Life Sciences in a consulting and/or industry roleExperience or exposure to the use of data, analytics, and/or AI-enabled tools to support business processes or decision-makingFoundational 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 organizationsExperience supporting the translation of regulatory and quality requirements into business processes, documentation, or controlsExperience supporting project delivery in areas such as compliance remediation, process improvement, system implementation, diligence, or integration planningFamiliarity 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 managementExperience supporting data analysis, reporting, dashboards, KPI tracking, or process monitoringExperience in project management, PMO support, or workstream coordinationAbility to manage multiple assignments and work effectively in a deadline-driven environmentStrong attention to detail and ability to produce polished, client-ready deliverablesStrong written and verbal communication skills and ability to work effectively in cross-functional teamsMust be legally authorized to work in the United States without the need for employer sponsorship, now or at any time in the futureAbility to travel up to 50%, based on the work you do and the clients and industries/sectors you serve Preferred Experience in the pharmaceutical, biotech, and/or medical device industriesExperience supporting eQMS, RIM, DMS, LMS, or related quality/regulatory technology initiativesExperience with compliance assessments, inspection readiness, remediation, or QA/RA process improvement Information for applicants with a need for accommodation: 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. 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 View email address on click.appcast.io. Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. 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 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. Qualified applicants with criminal histories, including arrest or conviction records, will be considered for employment in accordance with the requirements of applicable state and local laws, including the Los Angeles County Fair Chance Ordinance for Employers, City of Los Angeles’s Fair Chance Initiative for Hiring Ordinance, San Francisco Fair Chance Ordinance, and the California Fair Chance Act. See notices of various fair chance hiring and ban-the-box laws where available. Fair Chance Hiring and Ban-the-Box Notices | Deloitte US Careers Requisition code: 365602 Job ID 365602 Strategy, Growth, and Transformation | Functional and Operational Strategy and TransformationSame job available in 9 locations

Vacancy posted 2 days ago
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