Role Overview
The role is responsible for leading GCP Quality Assurance activities for in-house and outsourced BA/BE (Bioavailability/Bioequivalence) studies. The position ensures compliance with global and local GCP regulations, oversees quality systems, conducts audits, manages regulatory inspections, and drives continuous quality improvement initiatives across clinical research operations.
Key Responsibilities
Quality Management System (QMS) Oversight
Develop, review, and implement:
Quality Assurance SOPs
Global Quality Systems (GQS)
Global SOPs (GSOPs)
Collaborate with R&D and cross-functional stakeholders to strengthen quality systems.
Harmonize QA processes across in-house and outsourced studies.
Clinical Quality Audits
Conduct and lead:
BA/BE Study Audits
Healthy Volunteer Studies
Patient-Based Studies
Audit Types
Investigator Site Audits
Site Selection Visit (SSV) Audits
Trial Master File (TMF) Audits
Study Documentation Audits
Retrospective Audits
In-Process Audits
Objectives
Identify compliance gaps
Evaluate adherence to:
Study Protocols
SOPs
Regulatory Requirements
ICH-GCP Guidelines
Recommend corrective and preventive actions
Vendor & CRO Qualification
Conduct:
CRO Qualification Audits
CRO Re-Qualification Audits
Contract Service Provider (CSP) Audits
Supplier Qualification Audits
Evaluate vendor quality systems and compliance capabilities.
Ensure vendor compliance with applicable regulations and quality standards.
CAPA Management
Review and verify:
Corrective Actions (CA)
Preventive Actions (PA)
Assess adequacy and effectiveness of CAPA implementation.
Monitor closure of audit observations and regulatory findings.
GCP Compliance & Quality Oversight
Provide QA review and oversight for:
Clinical Study Protocols
Investigator Brochures (IB)
Informed Consent Forms (ICF)
Clinical Study Reports (CSR)
Study Plans
Trial Documentation
Ensure compliance with:
ICH-GCP
Local Regulations
International Regulations
Good Documentation Practices (GDP)
Regulatory Inspection Support
Support regulatory inspections and audits.
Coordinate with internal stakeholders during inspections.
Address regulatory observations and findings.
Facilitate timely responses to regulatory queries.
Drive implementation of inspection-related CAPAs.
Regulatory Intelligence
Stay updated on:
ICH-GCP Guidelines
CDSCO Regulations
Global Clinical Research Regulations
Emerging Regulatory Expectations
Provide guidance to study teams on regulatory compliance.
People Leadership & Development
Mentor and coach QA team members.
Conduct performance reviews.
Support employee development plans.
Build a strong quality-focused culture.
Lead and motivate teams across functions.
Technical Competencies
Clinical Quality & Compliance
ICH-GCP Guidelines
Clinical Trial Quality Systems
BA/BE Studies
Regulatory Inspection Management
CAPA Management
Vendor Qualification
Clinical Research Compliance
Audit Expertise
Internal Audits
External Audits
Investigator Site Audits
CRO Audits
Supplier Audits
TMF Audits
Regulatory Knowledge
CDSCO Regulations
Global GCP Requirements
Good Documentation Practices (GDP)
Clinical Research Regulatory Framework
Technology Skills
Clinical Quality Systems
Document Management Systems
Microsoft Office & IT Systems
Quality Tracking Tools
Behavioral Competencies
Leadership Skills
Team Leadership
Coaching & Mentoring
Stakeholder Management
Cross-Functional Collaboration
Personal Attributes
Integrity & Ethics
Customer Focus
Strategic Thinking
Problem Solving
Attention to Detail
Results Orientation
Independent Decision Making
Communication Skills
Strong Verbal Communication
Written Communication
Audit Reporting
Regulatory Interactions
Travel Requirement
Approximately 6–8 days per month
Travel for:
Site Audits
CRO Audits
Regulatory Inspections
Vendor Assessments
Equivalent Market Titles
Senior Manager – GCP Quality Assurance
Clinical Quality Assurance Manager
Lead GCP Auditor
Clinical Compliance Manager
Quality Systems Manager (Clinical Research)
Associate Director – Clinical Quality Assurance
GCP Compliance Lead
Experience Required
10+ years of experience in a GCP (Good Clinical Practice) environment
Minimum 6+ years of dedicated Quality Assurance (QA) experience
Experience in:
Clinical Research Quality Assurance
GCP Audits
Regulatory Inspections
CRO Qualification & Oversight
CAPA Management
Clinical Trial Compliance
Educational Qualification
Graduate or Postgraduate Degree in:
Life Sciences
Basic Sciences
Pharmacy
Biotechnology
Related Scientific Disciplines
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Bangor | Brewer |New Jersey :
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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
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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 :
Romania |Belgium :
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 :
Beijing |China :
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 :
Mississauga | North York | Renfrew | Australia | Uxbridge | Richmond Hill |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |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 :
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 :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Be'Er Sheva | Tel Aviv | Netanya | Yavne | Kfar Saba |Remote :
Belgium | Perth | Leinster | Regulatory Labeling Manager (NA and LATAM Only) | Springville | Minnesota | Bountiful | Lousiana | Remote - Africa | Remote - Middle East | Faridabad | Xzagreb | Hungary | Medan | Slovakia | Remote - South America (Latin Americal) | Hammond | Victoria | Green Way | Nairobi | Lenexa | Switzerland | French | Castlebar | Ireland | Riga | Remote - Europe | Texas | Bishop | Blue Bell | Melbourne | Zaragoza | McFarland | Tulsa | Milwaukee | Manipal | Thailand |Republic of Colombia :
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New Mexico | Ciudad de México |Dubai :
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Riyadh | Khulais | Jeddah | King Abdullah Economic City | Najran | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |
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