Practice Lead- Life Sciences

The Life Sciences Domain SME provides deep expertise and strategic guidance in areas such as pharmaceuticals, biotechnology, clinical research, regulatory affairs, and life-science business processes. This role is responsible for ensuring regulatory compliance, and industry alignment across projects, solutions, and client engagements. The SME collaborates with cross-functional teams to support product development, solution design, quality initiatives, process optimization, and customer success. As an expert of Life Sciences Industry, you will contribute to the develop business opportunities by closing interlocking with the regional sales team. A strong background in Life Sciences Industry and Pre-Sales experience are required for this position. Overall, 15+ years of experience (with minimum of 10–12 years in life sciences domain covering pharma/biotech/clinical research).

About the Role

This role is responsible for providing deep expertise and strategic guidance in the Life Sciences domain, ensuring regulatory compliance, and collaborating with cross-functional teams to support various initiatives.

Responsibilities

Domain Expertise & Thought Leadership

• Serve as the primary subject matter expert in life sciences (pharma, biotech, clinical trials, medical devices, regulatory or related areas).
• Provides insight on industry trends, scientific advancements, and regulatory updates (FDA, EMA, ICH, GxP).
• Contribute to development of best practices, frameworks & knowledge repositories.
• Design offerings to develop business in line with group Life Sciences Strategy.
• Promote the offerings to internal stakeholders (sales, marketing, projects) and external (clients).

Project Solution Support

• Guide product/solution design with deep domain knowledge.
• Support business analysts, product managers, and technical teams in requirements gathering and validation.
• Review and validate solution documents (author, consult, review and approve SDLC deliverables), workflows, business rules, and functional specifications.
• Partner with product, engineering, quality, and operations teams to translate domain needs into actionable requirements.
• Support testing teams by validating test coverage, reviewing test results, and ensuring domain correctness.
• Contribute to technical and non-technical documentation.
• Contribute, if necessary, to the delivery services (billed hours) to guarantee project delivery and profitability.

Presales Solution Support

• Produce best technical bid proposals in implementing different delivery models according to the Group standards and rules, ensure the full buy-in of sales and operation teams.
• Contribute actively to the bid process, from early stage to close stage and ensure agility and creativity to propose the best solutions to clients.
• Develop relationship and business opportunities with clients and strategic partners.
• Support and organise up-skilling of Sales on major offers.
• Contribute to marketing campaign, events, communication.

Client & Stakeholder Engagement

• Work directly with clients to understand needs, present domain-driven solutions, and provide expert recommendations.
• Participate in client workshops, requirement discussions and proposal development.
• Deliver presentations, training sessions, demonstrations highlighting domain capabilities.

Regulatory & Compliance Oversight

• Ensure solutions comply with relevant life sciences regulations (e.g., GxP, 21 CFR Part 11, GAMP, ISO 9001 and ISO 27001).
• Provide guidance on clinical, safety, and quality processes such as PV, QMS, CSV/CSA, manufacturing and clinical operations.

Cross-Functional internal Collaboration

• Implement the practice strategy defined by the CBU (capabilities business unit) locally, guide, mentor and ensure a cohesive approach in terms of skills and technical resources.
• Contribute actively to the development a global talent pool, including plans for training and development of the consultants’ team to ensure a diverse & skilled workforce available to meet client’s needs.

Training & Knowledge Transfer

• Conduct internal training sessions to upskill teams on industry standards, terminology, and workflows.
• Assist in creating user manuals, training materials, and domain certification paths.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Pharmacy, Biomedical Engineering, or related field.
• Overall, 15+ years of experience (with minimum of 10–12 years in life sciences domain covering pharma/biotech/clinical research).
• Strong understanding of regulatory frameworks (FDA, EMA, ICH, GxP, GDPR, HIPAA, GAMP, 9001, 27001 etc.).
• Quality Management: Quality Assurance, Operational Quality, Supplier Quality, Quality Management System, Regulatory affairs, knowledge of microbiology and contamination, knowledge of pharmaceutical regulation (GMP/GxP, ICH, ISO13485…).
• Experience with life-science platforms/processes (e.g., clinical trials, PV, QMS, LIMS, R&D, manufacturing).
• Ability to translate complex scientific concepts into business and regulatory requirements.
• Excellent communication, analytical thinking, and documentation skills.

Required Skills

• Experience working with digital/IT solutions in life sciences (e.g., SaaS platforms, cloud systems, AI/ML products).
• Certifications such as ASQ, RAC, PMP, Six Sigma, ISO 9001, ISO 27001 or domain-specific credentials.
• Experience in consulting or customer-facing SME roles.
• Knowledge of FDA regulations, 21CFR part 11, EU Annex 11, Annex 22, HL7, FHIR is a plus.

Preferred Skills

• Well organized and independent in daily task with a good team spirit.
• Effective communicator with the