I&D Operational Excellence Specialist
Location: Mumbai, India
Category: Regulatory Affairs
Company Type: Global Pharmaceutical / Healthcare Organization
Job Summary
The I&D Operational Excellence Specialist plays a key role in managing training governance, documentation standards, and compliance processes across Innovation & Development (I&D) functions. This position supports activities for Medical Affairs, Clinical Development, Product Development, and Regulatory teams, ensuring consistent implementation of quality systems, training frameworks, and regulatory alignment.
This role is ideal for professionals with solid experience in Quality Management Systems (QMS), training coordination, documentation oversight, and compliance governance within the pharmaceutical or life sciences sector.
Key Responsibilities
Training Management
Implement and maintain I&D training programs across global, regional, and local teams.
Manage documentation workflows and support system activities for I&D learning platforms (e.g., ISOtrain).
Maintain user training matrices, curricula, and training metrics.
Prepare, update, and coordinate I&D quality system documentation with Quality teams.
Assist with course creation, content upload, and training assignment within learning systems.
Support onboarding activities by preparing structured training packages.
Serve as system super user for ISOtrain, DARIUS, and I&D Training Matrix platforms.
Oversee ISOtrain profile creation, curricula assignment, and training record maintenance.
Governance & Compliance
Support compliance, governance, and quality control activities for Global I&D functions.
Conduct self-inspection activities and track compliance metrics as per departmental guidelines.
Review I&D records to ensure alignment with global regulatory standards and applicable policies.
Perform document quality control reviews (content consistency, formatting, pagination, grammar, references).
Assist in internal and external audits or inspection readiness activities.
Position Scope
Lead I&D training initiatives across functional groups.
Oversee document quality control activities and self-inspection workflows.
Collaborate with cross-functional stakeholders, including:
Medical Affairs
Clinical Development
Pharmacovigilance
Regulatory Affairs
Product Innovation & Development
I&D Quality
Ethics & Compliance
Interface with global vendors, consultants, and external business partners as required.
Education Requirements
Post Graduate Diploma in Quality Assurance (Pharmaceuticals or Food Industry).
Bachelor’s or Master’s degree in Life Sciences or related discipline.
Experience Required
Minimum 6 years of experience in Quality Management Systems, Training Management, or related functions within the pharmaceutical, biotechnology, life sciences, or healthcare industry.
Proven experience managing training operations for large functional groups is preferred.
Strong proficiency in Microsoft Excel for tracking metrics, generating reports, and performing data analysis.
Why This Role Matters
This position ensures that complex global I&D functions adhere to regulatory standards, maintain high-quality documentation, and operate with consistency across all training and compliance processes. It is a critical role for maintaining operational excellence within a regulated environment.
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