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.
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Assam :
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Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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Baddi | Solan |India :
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Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Kerala :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Odisha :
Bhubaneswar | Rourkela |PAN-India :
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Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Sikkim :
Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |West Bengal :
Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
Tuscaloosa |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
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Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Carlos | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |Colorado :
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Frank Scottile Blvd |LA :
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Bangor | Brewer |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
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Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |New Mexico :
Albuquerque | Farmington | Santa Fe | Tucumcari |New York :
Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |North Carolina :
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Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |Oklahoma :
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Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Pennsylvania :
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Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |United States :
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Ingelheim am Rhein | Mainz |Rotherbaum :
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Saarbrucken |Saxony Anhalt :
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Kiel |Belgium :
Wavre |BULGARIA :
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Copenhagen | Denmark |Europe :
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Galway |Meath :
Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
Ballydine |Ulster :
Donegal |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
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Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
South Yarra |New South Wales :
Ballina | Sydney |Queensland :
Queensland |Remote Australia :
Arkansas | Remote Australia |Republic of Western Australia :
Nedlands |Capital of Netherland :
Amsterdam |Netherlands :
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Haarlem |North Brabant :
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Leiden |North Yorkshire :
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Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
North York | Renfrew | Richmond Hill | Mississauga | Uxbridge | Australia |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
Bogota |Croatia :
Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
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Tallinn |Chuuk :
North Ostrobothnia :
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Turku |France :
Lyon | Paris |Attica :
Athens | Koropi |Greece :
Greece |East Java :
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Jakarta |Israel :
Be'Er Sheva | Kfar Saba | Tel Aviv | Yavne | Netanya |Italy :
Italy |Lombardy :
Rho |Japan :
Japan | Saitama |Tokyo :
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Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
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Ciudad de México |New Zealand :
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Auckland |Lima Region :
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Warsaw |Remote :
Victoria | Riga | Switzerland | Green Way | Lenexa | Zaragoza | Remote - Middle East | Remote | Slovakia | Minnesota | Leinster | Nairobi | Springville | Hungary | Ireland | Remote - Europe | Tulsa | Remote - Africa | Xzagreb | Hammond | Belgium | French | Bishop | Medan | Texas | Lousiana | Bountiful | Melbourne | Faridabad | Remote, USA | Castlebar | Blue Bell | Thailand | Remote - South America (Latin Americal) | McFarland | Manipal |Bucharest :
Bucharest |Makkah :
Najran | Jeddah | King Abdullah Economic City | Khulais | Riyadh | Rabigh |Nišava District :
Niš |Singapore :
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Midrand | South Africa |Brazil :
Sao paulo | Brazil |South America :
Argentina | Peru |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
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Ho Chi Minh City |