Manager – R&D Quality GCP QA
Location: Vadodara, Gujarat, India
Employment Type: Full-Time
Department: R&D Quality / Clinical Quality Assurance / Good Clinical Practice (GCP) Quality
Experience Required: 10+ Years (Including Minimum 6 Years in Quality Assurance)
Job Overview
A senior quality leadership opportunity is available for an experienced Manager – R&D Quality GCP QA within the pharmaceutical research and development quality domain. This role is ideal for professionals with deep expertise in Good Clinical Practice (GCP) quality assurance, clinical audits, CRO oversight, regulatory inspection readiness, CAPA management, clinical compliance, and outsourced clinical study quality governance.
The selected candidate will play a critical role in strengthening clinical quality systems, overseeing GCP compliance for in-house and outsourced BA/BE studies, conducting quality audits, supporting regulatory inspections, and driving continuous improvement across R&D quality operations.
This role is highly suited for professionals seeking advancement in clinical quality assurance, GCP compliance leadership, audit governance, regulatory inspection management, and pharmaceutical quality systems.
Key Responsibilities
GCP Quality Systems & SOP Governance
Clinical Audit Management
Lead and execute quality audits across in-house and outsourced BA/BE clinical study operations, including:
Assess adherence to:
CRO / Vendor Qualification & Oversight
CAPA Management & Quality Remediation
GCP Quality Oversight
Provide QA oversight for development and review of clinical study documentation including:
Ensure compliance with:
Regulatory Inspection Support
Regulatory Intelligence & Compliance Monitoring
Team Leadership & Capability Development
Required Qualifications
Educational Qualifications
Candidates must hold:
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 :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | parel | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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 :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tamil nadu | Tiruchirappalli | tiruppur | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Madhya Pradesh :
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Bhubaneswar | Rourkela |Chhattisgarh :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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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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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Boise |Colorado :
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Dickinson |Minnesota :
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Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
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Hilo | Honolulu |Tennessee :
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Lake Charles | Shreveport |Nevada :
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Lisbon | Oeiras | Portugal |WI :
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Mexico |northeastern :
New Hampshire |Oklahoma :
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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 :
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Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
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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 :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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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 :
Mississauga | Uxbridge | North York | Australia | Richmond Hill | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Jakarta |East Java :
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Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Slovakia | Thailand | Remote - South America (Latin Americal) | Leinster | Hammond | Bishop | Victoria | Remote, USA | Xzagreb | Belgium | Bountiful | Lousiana | Ireland | Castlebar | Green Way | Blue Bell | Medan | Remote - Europe | Springville | McFarland | Zaragoza | Remote | Switzerland | Lenexa | Faridabad | Remote - Middle East | Nairobi | Minnesota | Tulsa | Regulatory Labeling Manager (NA and LATAM Only) | Hungary | Remote - Africa | Manipal | Riga | Texas | Melbourne | French |Republic of Colombia :
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Buenos Aires |Republic of Egypt :
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King Abdullah Economic City | Najran | Khulais | Rabigh | Riyadh | Jeddah |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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Sweden |Taipei :
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Warsaw |
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