Manager- Product Quality & Safety - Life Sciences & Healthcare

Manager - 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 Manager, you will lead the delivery of client engagements and manage teams supporting life sciences clients across Regulatory Affairs and Quality Assurance. You will bring subject matter expertise, structured problem solving, and strong engagement management to help clients address quality, regulatory, operational, and technology-related challenges across pharmaceutical, biotech, and medical device environments. This could include:

• Lead client workstreams and teams supporting pharmaceutical and medical device Regulatory Affairs and Quality Assurance strategy, process, operating model, and governance improvements
• Manage quality and regulatory due diligence for mergers and acquisitions, including diligence planning, evidence requests, interview leadership, risk identification, issue synthesis, and diligence reporting
• Lead separation and integration activities for QA/RA functions, including Day 1 readiness, target operating model design, TSA planning, governance, and cutover execution
• Assess quality management system and regulatory compliance gaps across areas such as SOPs, training, deviation management, CAPA, change control, complaints, audits, and inspection readiness
• Lead inspection readiness efforts, including mock inspections, observation response planning, remediation roadmap development, and stakeholder alignment
• Manage QA/RA technology enablement efforts, including requirements definition, future-state process design, vendor evaluation support, validation coordination, testing oversight, training, deployment, and adoption planning
• Lead 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
• Oversee development of client-ready deliverables, including assessments, operating model designs, process flows, requirements, business cases, implementation plans, executive presentations, and steering materials
• Manage project plans, budgets, risks, dependencies, issue resolution, and stakeholder communications across workstreams
• Serve as a day-to-day client leader for assigned workstreams, building trusted relationships and aligning stakeholders on scope, priorities, and decisions
• Coach junior practitioners, review team output for quality, and contribute to the development of Deloitte methodologies and service offerings in QA/RA and Commercial/Medical Content Management
• Identify opportunities to apply data, analytics, and AI-enabled tools to improve compliance, quality operations, reporting, and decision-making

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 mentor and 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 required
• 7+ years of experience focused on Life Sciences in a consulting and/or industry role
• Experience leading teams and delivering complex client engagements in pharmaceutical, biotech, and/or medical device environments
• Experience applying data, analytics, and/or AI-enabled tools to drive measurable business outcomes such as automation, insight generation, risk monitoring, or decision support
• Strong 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)
• Strong working knowledge of regulatory and quality expectations applicable to pharmaceutical and/or medical device organizations
• Experience translating regulatory and quality requirements into operating models, business processes, controls, and performance metrics
• Experience leading QA/RA-related M&A diligence, including planning, data room requests, management interviews, risk rating, and diligence reporting
• Experience leading separation and integration activities for QA/RA functions, including process and system disentanglement, integration design, governance, TSA planning, and cutover execution
• Ability to identify, assess, and communicate quality and regulatory risks that impact transaction value, remediation cost, operational continuity, supply risk, and launch or approval timelines
• Experience implementing or optimizing quality and regulatory systems, including requirements gathering, future-state process design, validation 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 or product registration data management
• Experience with QA/RA data, dashboards, KPIs, traceability, audit trails, and sustainment planning
• Strong project and program management experience, including scope, budget, timeline, RAID management, and executive reporting
• Experience working in a deadline-driven environment and managing multiple client assignments simultaneously
• High attention to detail and ability to produce high-quality, client-ready deliverables for executive and professional audiences
• Experience coaching and mentoring cross-functional teams
• Strong written and verbal communication skills, including executive-level presentation and facilitation
• 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

Preferred

• 3+ years of experience in the pharmaceutical, biotech, and/or medical device industries
• Experience leading eQMS, RIM, DMS, LMS, or related quality/regulatory technology initiatives
• Experience with compliance assessments, inspection readiness, remediation, or QA/RA operating model transformation
• Experience supporting business development, proposal development, or service offering enhancement

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 $134500- $265100.

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.