Manager – R&D Quality GCP QA
Location: Vadodara, India
Business Unit: Sun R&D Quality
Job Grade: G11A / G10
Employment Type: Full-Time
Company: Sun Pharmaceutical Industries Ltd.
Job Summary
The Manager – R&D Quality GCP QA is responsible for ensuring compliance with Good Clinical Practice (GCP), applicable regulatory requirements, company quality standards, and global quality systems across clinical research and Bioavailability/Bioequivalence (BA/BE) studies.
The role provides Quality Assurance oversight for both in-house and outsourced clinical research activities, including audit management, vendor qualification, CAPA oversight, regulatory inspection readiness, quality system development, and continuous process improvement initiatives.
The incumbent will work closely with Clinical Operations, Regulatory Affairs, Medical Affairs, Bioanalytical Teams, CROs, and other R&D stakeholders to ensure the highest standards of quality, compliance, and patient safety.
Key Responsibilities
Quality Management Systems & Compliance
Evaluate existing quality systems, processes, and procedures within clinical research operations.
Develop, review, implement, and maintain:
Standard Operating Procedures (SOPs)
Global Quality Systems (GQSs)
Global SOPs (GSOPs)
Quality Policies and Guidelines
Ensure alignment of quality systems with:
ICH-GCP Guidelines
National Regulatory Requirements
International Regulatory Standards
Company Quality Frameworks
Drive continuous improvement initiatives to strengthen quality and compliance culture.
GCP Audits & Quality Oversight
Plan, conduct, and manage quality audits for in-house and outsourced clinical studies, including:
Clinical Study Audits
Investigator Site Audits
Site Selection Visit (SSV) Audits
Trial Master File (TMF) Audits
In-Process Audits
Retrospective Study Audits
Study Documentation Audits
BA/BE Study Audits
Healthy Volunteer Studies
Patient-Based Studies
Bioavailability Studies
Bioequivalence Studies
Assess compliance with approved study documents, protocols, SOPs, and regulatory requirements.
Identify compliance gaps and recommend corrective actions.
Prepare audit reports and communicate findings to stakeholders.
Vendor Qualification & Oversight
Conduct qualification and requalification audits of:
Contract Research Organizations (CROs)
Contract Service Providers (CSPs)
Clinical Vendors
Material Suppliers
Evaluate vendor quality systems and operational capabilities.
Assess compliance with applicable GCP requirements.
Support vendor selection and qualification processes.
CAPA Management
Review, verify, and approve:
Corrective Actions (CA)
Preventive Actions (PA)
CAPA Plans
Root Cause Analyses
Assess adequacy and effectiveness of CAPAs arising from:
Internal Audits
External Audits
Regulatory Inspections
Corporate Quality Reviews
Monitor implementation and closure of CAPAs.
Ensure sustainable resolution of quality issues.
Clinical Study Documentation Review
Provide Quality Assurance oversight for creation and review of:
Clinical Study Protocols
Investigator Brochures (IBs)
Informed Consent Forms (ICFs)
Study Plans
Clinical Study Reports (CSRs)
Trial Master Files (TMFs)
Quality Management Documentation
Ensure compliance with:
GCP Guidelines
Regulatory Requirements
Good Documentation Practices (GDP)
Regulatory Inspection Readiness
Support preparation and management of:
Regulatory Inspections
Sponsor Audits
Internal Audits
Compliance Reviews
Collaborate with study teams to ensure inspection readiness.
Participate in inspection management activities.
Support preparation of responses to regulatory observations and findings.
Regulatory Support
Support preparation and review of responses to regulatory authority queries.
Collaborate with Regulatory Affairs and Clinical Operations teams to address compliance concerns.
Assist in development of strategies for regulatory inspection preparedness.
Quality Harmonization & Process Improvement
Harmonize quality systems and procedures across:
In-House Clinical Studies
Outsourced Clinical Studies
BA/BE Programs
Identify opportunities for process optimization.
Implement best practices and quality improvements.
Support organizational quality excellence initiatives.
Regulatory Intelligence & Compliance Monitoring
Monitor updates to:
ICH Guidelines
Good Clinical Practice (GCP) Regulations
Clinical Research Regulations
Global Regulatory Requirements
Evaluate impact of regulatory changes on quality systems.
Provide expert guidance on compliance requirements to stakeholders.
Leadership & People Development
Mentor, coach, and develop team members.
Provide ongoing performance feedback and professional development support.
Conduct training on:
GCP Requirements
Quality Systems
Audit Readiness
Compliance Standards
Promote a culture of quality, accountability, and continuous improvement.
Educational Qualifications
Required
Bachelor’s or Master’s Degree in:
Life Sciences
Pharmacy
Clinical Research
Biotechnology
Biological Sciences
Healthcare Sciences
Related Scientific Discipline
Experience Requirements
Required
Minimum 10 years of experience in a GCP-regulated clinical research environment.
Minimum 6 years of direct experience in Quality Assurance (QA).
Preferred
Experience auditing BA/BE studies.
Experience supporting global clinical research programs.
Experience managing regulatory inspections and CAPA programs.
Experience working with CROs and outsourced clinical service providers.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Punjab :
amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
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Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
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Birmingham |Virginia :
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Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
Charleston |Kansas :
Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
Haarlem |South Holland :
Leiden |Netherlands :
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 :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Mississauga | Uxbridge | Renfrew | Australia | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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New Mexico | Ciudad de México |Dubai :
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Khulais | Jeddah | Najran | King Abdullah Economic City | Rabigh | Riyadh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
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Warsaw |
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