Overview
In this role you will lead delivery and transformation efforts for Life-Sciences & Healthcare clients, focusing on regulatory-compliant projects and CSV. You will partner with cross-functional teams to ensure quality, risk management, and timely delivery while mentoring junior colleagues. The position offers exposure to AI-enabled solutions within regulated environments and opportunities to shape service offerings. You will contribute to a culture of inclusion and continuous learning at Deloitte.
Pay / Benefits
- Hybrid working
- Learning and qualifications
- Career development
- Mentorship
- Wellbeing support
Responsibilities
- Lead programs or workstreams, owning project planning, resource allocation, budgets, and delivery of high-quality outcomes.
- Manage client relationships as a trusted advisor and ensure satisfaction.
- Apply robust project management methodologies, including agile where appropriate.
- Identify and mitigate project risks to keep initiatives on track.
- Provide oversight of end-to-end Computer System Validation (CSV) and regulatory compliance activities in the GxP domain.
- Develop validation strategies and documentation (VMPs, URS, FS, DS, Test Plans, TRS, Validation Reports).
- Advise on data integrity, electronic records/signatures, and AI governance in regulated settings.
- Contribute to QMS design, implementation, and optimization within life sciences environments.
- Support business development, proposals, thought leadership, and new client opportunities.
- Mentor junior team members and stay updated on evolving regulatory and tech landscapes.
Key requirements
- Bachelor’s degree in a relevant scientific, engineering, or technology discipline.
- Experience leading major programs/projects in a GxP-regulated environment.
- Oversight or leadership of CSV and/or regulatory compliance in Life Sciences & Healthcare.
- Expertise in GMP, GCP, GLP, GVP, 21 CFR Part 11, Annex 11, and GAMP 5.
- High-level understanding of standards such as ISO-13485 and ISO-14971.
- Proven project management experience (planning, execution, risk management, stakeholder communication).
- Familiarity with agile methodologies in regulated environments.
- Strong analytical, problem-solving, and communication skills.
- Strong communication and interpersonal skills
- Negotiation and stakeholder management
- Presentation and clarity in explaining complex concepts
- MES (PAS-X)
- ERP (SAP S4)
- LIMS, EDMS, CTMS
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