Digital Quality and Compliance Consultant - Life Sciences

Role Overview Capgemini Invent is seeking an experienced Manufacturing and Quality Data Expert with a strong background in Life Sciences to join our growing practice in Bengaluru. In this role, you will collaborate with global BioPharma and Med-Tech clients to drive digital quality transformation initiatives across the value chain. You will engage directly with C-Suite executives and senior leadership to design and deliver high-impact programs spanning Quality, Regulatory Compliance, Intelligent Operations, and Digital Transformation. Key Responsibilities - Assess existing quality states and define digital quality strategies and transformation roadmaps for life sciences clients - Develop and implement quality SOPs covering Data Governance, IT QMS, Change Control, Non-Conformance, and CAPA frameworks - Resolve complex quality and compliance challenges by applying data-driven insights and analytical tools - Drive continuous improvement initiatives ensuring adherence to GMP, FDA, and ISO standards - Enable quality transformation through automation, analytics, artificial intelligence, and digital platforms - Design Digital Quality Operating Models, define relevant KPIs, and lead improvement engagements end to end - Deliver expertise in GxP validation, SDLC, Agile methodologies, and ALCOA+ data lifecycle management - Advise client stakeholders on quality systems, regulatory compliance, and digital enablement strategies Required Qualifications - Bachelor's degree in Life Sciences, Business, or a related field; MBA from a top-tier institution preferred - 6 to 9 years of experience in life sciences quality systems consulting or relevant industry roles - Hands-on experience with Digital QMS platforms such as Veeva, MasterControl, TrackWise, EtQ, or ComplianceWire - Strong knowledge of GxP Compliance, Regulatory Affairs, Audits, and Periodic Reviews - Experience with MES, Manufacturing IoT, Analytics, Big Data, and Process Improvement - Proficiency in end-to-end validation including CSV and CSA for ERP, LIMS, AI/ML, IoT, Cloud, and Digital Health - Deep understanding of FDA, EMA, MHRA regulations and standards such as ISO, IMDRF, and PIC/S - Certifications in Lean Six Sigma, ASQ, CPSM, or RAC are an added advantage Why Join Us Capgemini Invent offers a dynamic consulting environment where you will work on some of the most complex and meaningful transformation programs in the global Life Sciences industry. This is an exceptional opportunity to grow your expertise, collaborate with world-class professionals, and make a measurable impact on patient safety and healthcare innovation.

- Experience with Digital QMS platforms such as Veeva, MasterControl, TrackWise, EtQ, or ComplianceWire - Strong knowledge of GxP Compliance, Regulatory Affairs, and Audits - Expertise in GxP validation, SDLC, Agile, and ALCOA+ data lifecycle management - Understanding of FDA, EMA, MHRA, ISO, IMDRF, and PIC/S standards - Experience in MES, Manufacturing IoT, Analytics, and Big Data - End-to-end CSV and CSA validation for ERP, LIMS, AI/ML, IoT, and Cloud platforms - Strong problem-solving, communication, and stakeholder management skills - 6 to 9 years of relevant experience in life sciences quality systems or consulting - Bachelor's degree in Life Sciences, Business, or related field; MBA preferred - Lean Six Sigma, ASQ, CPSM, or RAC certification is a plus

- Opportunity to work with leading global BioPharma and Med-Tech organizations - Exposure to C-Suite and senior leadership engagements - Work on high-impact digital transformation programs - Collaborative and innovation-driven work culture - Learning and certification support