I&D Operational Excellence Specialist
Location: Mumbai, India
Department: Regulatory Affairs
Experience Required: Minimum 6 years in Quality Management Systems and Training Management
Job Overview
ThePharmaDaily.com is seeking an I&D Operational Excellence Specialist to lead training governance, quality oversight, and compliance activities across Innovation & Development (I&D) functions. This role supports Medical, Clinical, Product Development, and Regulatory teams by managing training systems, documentation standards, and global quality requirements. The position requires strong technical expertise, precision in quality control, and the ability to collaborate with cross-functional stakeholders.
Primary Job Function
Responsible for end-to-end training management, governance, and quality assurance for I&D functions, ensuring alignment with regulatory expectations, global compliance standards, and organizational quality frameworks.
Core Responsibilities
Training Management
Implement and oversee training activities across all I&D functions.
Support the operation and maintenance of documentation and learning management systems, including ISOtrain.
Manage I&D training metrics and ensure accuracy of training data.
Maintain and update user training matrices and learning curricula.
Prepare quality system documents and collaborate with the Quality team for approvals.
Upload training content, develop courses, and ensure accurate configuration within ISOtrain.
Prepare onboarding training packages for I&D and coordinate training assignments.
Act as a system super user for platforms such as ISOtrain, DARIUS, and the I&D Training Matrix Platform.
Manage ISOtrain system setup, including profile creation, curricula assignment, and training record maintenance.
Governance and Compliance
Support global compliance and quality control activities for I&D functions, including periodic self-inspections.
Maintain and update departmental quality and compliance metrics.
Ensure training documentation and I&D records comply with global standards and regulatory requirements.
Conduct quality control reviews of documents, ensuring accuracy in content, formatting, referencing, and grammar.
Assist in internal and external inspection activities related to training and documentation processes.
Position Accountability and Scope
Lead all I&D training initiatives and ensure consistent execution across teams.
Oversee quality control reviews, documentation consistency, and self-inspection activities.
Work closely with internal stakeholders, including:
Integration and Strategic Excellence
Medical Affairs
Clinical Development
Pharmacovigilance
I&D Quality
Regulatory Affairs
Product Innovation & Development
Office of Ethics and Compliance (Global, Regional, and Local)
Coordinate with external stakeholders, including contractors, vendors, and consultants.
Qualifications
Education
Post Graduate Diploma in Quality Assurance for the Food and Pharmaceutical Industry.
Bachelor’s or Master’s degree in Life Sciences or related scientific fields.
Experience
Minimum 6 years of experience in Quality Management Systems and Training Management.
Experience managing training programs for large or cross-functional groups is preferred.
Strong technical proficiency in Excel for metrics tracking, analysis, and reporting.
Gujarat :
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Rangpo |India :
Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Frank Scottile Blvd |Missouri :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
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Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
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Canada |Quebec :
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Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
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Auckland |New Zealand :
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Barcelona |Madrid :
Madrid |Cebu Province :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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