Job Description
Must Have
Lead - Business Process
You will be responsible for:
CMMI, ISO 9001, ISO 27001 and ISO 27701 based process facilitation for enabling functions and Business Units. The role will independently handle the following activities:
- Documentation Management: Review of institutionalized, Org wide documents, and of different BUs for publishing in iKnowledge. Handling Documentation clarifications request from different teams. Managing the MLD for all the BU's and Enabling function
- Gap analysis and improvement of operating framework
- Support with process documentation for CMMI level 5 implementation (work closely with SQA, and Process Team)
- Demonstrate improved efficiency for document management (Automation opportunities, simplification of process etc.)
- Manage ad hoc requests related to documentation management
- Adobe Access request management
- Help coordinate with external audit bodies and internal audit teams regarding third party audits, certification audits and assurance audits.
- Participate in real-time client audits and due diligence
- Support for Remote Audits, including online audits
- Support for Certification Audit Closures
- Support for Client audits with respect to SOP for Documentation and Indegene’s Operating framework (Integrated operatin framework based on CMMI, ISO standards and relevant industry practices)
- Support implementation & compliance with Indegene’s operating framework including training. Particularly on Data Privacy, Information Security and Quality Management SystemsSupport project management of new initiatives & innovation programsProject Manage process transition for new acquisitions
Your impact:
About you: (Desired profile)
We have requirements for the position of Lead – Business Process. Candidates with over 5 to 6 years of relevant prior experience may be considered.Our team is multi-disciplinary, and team members are expected to contribute to process management across Indegene’s global offices, while nurturing core competence in quality assurance standards and process improvement methodologies.
Must have: (Requirements)Lead Auditor certifications on at least any two of the following standards: ISO 9001:2015, ISO 27001:2022 or ISO 27701:2025
Working knowledge of SharePoint (Basics)
Analytical capability supplemented with good reporting experience
Effective communication including presentation and interpersonal skills with the ability to deal with people at various levels professionally
Ability to translate technicalities and concepts in non-technical and end-user friendly language (Technical documentation skills)
Graduate in any discipline
Good to have
- Exposure to process improvement methodologies such as CMMI
- Experience working in the healthcare-pharma industry
Relevant AI skills: (Recommended for this role)
- Practical understanding of generative AI tools for drafting, reviewing and standardizing SOPs, policies, audit responses and process documentation, with strong human validation.
- Ability to identify AI and automation opportunities in document management, workflow simplification, compliance tracking and reporting.
- Knowledge of AI-assisted data analysis for gap analysis, trend identification, audit readiness and continuous improvement initiatives.
- Awareness of responsible AI practices, including privacy, information security, accuracy, bias awareness, traceability and appropriate human oversight for regulated environments.
- Familiarity with AI governance considerations relevant to quality, information security and privacy management systems.
- Experience using AI copilots or intelligent search tools to accelerate knowledge retrieval, training support and responses to documentation clarifications.
- Understanding of healthcare compliance sensitivity when using AI, especially for confidential, regulated or personal data