Manager, Quality Trust and Compliance

2 days ago

Hyderabad City Taluka, Pakistan Endpoint Clinical Full time
Job Summary

The Vendor Qualification Manager is responsible for overseeing the qualification, monitoring, and ongoing assessment of vendors that support GxP systems and services. This role ensures that vendors are selected, assessed, and managed in accordance with applicable regulatory requirements (FDA, EMA, MHRA), GAMP 5 principles, and internal quality standards.

ResponsibilitiesVendor Qualification & Assessment
  • Lead and execute vendor qualification activities for GxP-relevant third-party providers (e.g., SaaS, IRT, eTMF, CROs, IT service providers).
  • Develop and maintain the vendor qualification strategy and risk-based assessment framework.
  • Conduct vendor audits (remote and on-site), prepare audit plans, reports, and CAPA follow-up.
  • Maintain up-to-date documentation for vendor qualification including risk assessments, questionnaires, and technical agreements.
Governance & Lifecycle Oversight
  • Establish and maintain a centralized vendor inventory and qualification status.
  • Collaborate with Procurement, IT, Validation, and Business Owners to ensure vendor compliance throughout lifecycle.
  • Ensure appropriate contracts, Quality Technical Agreements (QTAs), and SLAs are in place.
  • Participate in vendor onboarding and change control processes for qualified vendors.
Compliance & Continuous Improvement
  • Stay abreast of evolving regulatory expectations for third-party oversight.
  • Support inspection readiness and represent vendor oversight during audits or regulatory inspections.
  • Identify areas for improvement in vendor management processes and drive continuous improvement.
  • Provide training and guidance on vendor qualification procedures across functions.
Education
  • Bachelor's or Master's degree in Life Sciences, Computer Science, Quality, or a related field.
Experience
  • Minimum 5–8 years of experience in QA, compliance, or validation roles in the life sciences industry.
  • 3+ years of direct experience in vendor qualification or third-party oversight for GxP systems.
  • Experience conducting vendor audits and managing supplier CAPAs.
  • Strong knowledge of GxP regulations (21 CFR Part 11, EU Annex 11), GAMP 5, and ICH Q10.
Skills
  • In-depth understanding of software development lifecycles and cloud vendor qualification (e.g., SaaS).
  • Strong analytical, communication, and negotiation skills.
  • Ability to manage multiple priorities in a fast-paced environment.
  • Proficiency in quality systems and tools (e.g., eQMS, VMS, audit tracking tools).
Preferred Qualifications
  • Auditor certification (e.g., ISO 9001, ISO 27001, or equivalent).
  • Knowledge of data integrity principles and AI/ML vendor oversight.
  • Familiarity with privacy requirements (GDPR, HIPAA) for vendor assessment.
Working Conditions
  • Some travel required (~15–25%) for on-site vendor audits
  • May require flexible hours to work with global teams

#J-18808-Ljbffr

  • Compliance Manager

    2 days ago

    Hyderabad City Taluka, Pakistan Backbase Full time

    OverviewThe job in shortAs an IT Governance, Risk and Compliance (GRC) Manager, you enable Backbase in conducting its business in full compliance with all relevant national and international laws and regulations. This also includes professional standards, accepted business practices, internal policy standards and IT Security frameworks such as SOC2, ISO27001...

  • Quality Assurance and Compliance Specialist

    2 days ago

    Hyderabad City Taluka, Pakistan beBeeVendor Full time $1,100,000 - $1,300,000

    Job TitleThe Vendor Qualification Specialist is responsible for overseeing the qualification and management of vendors that support GxP systems and services. This role ensures that vendors are selected, assessed, and managed in accordance with applicable regulatory requirements, industry standards, and internal quality processes.ResponsibilitiesVendor...

  • Compliance Team Manager

    5 days ago

    Hyderabad City Taluka, Pakistan beBeeEnhanced Full time ₹2,590,500

    Job OpportunityWe are seeking a highly skilled and experienced Team Lead to join our Enhanced Due Diligence team. The successful candidate will be responsible for hiring, developing, and leading a diverse and high-performing team, driving process improvements, and utilizing their Compliance background to collect feedback and drive upstream enhancements.The...

  • Statutory Compliance Manager

    4 days ago

    Hyderabad City Taluka, Pakistan beBeeCompliance Full time 5,500,000 - 7,500,000

    Job DescriptionThe Operations Partner - Statutory Compliance plays a pivotal role in ensuring full adherence to applicable legal and regulatory frameworks, supporting HR operational compliance, and overseeing administrative functions critical to plant operations.This position is responsible for maintaining a safe, ethical, and legally compliant workplace...

  • Tax Professional

    2 days ago

    Faisalabad City Tehsil, Pakistan beBeeEstate Full time $66,900 - $122,200

    Senior Associate Estate Tax Position OverviewWe are seeking a skilled professional to join our team as a Senior Associate in Estate and Administrative Trust. This role is ideal for individuals who possess strong analytical skills, excellent communication abilities, and a passion for delivering high-quality tax solutions.Key Responsibilities:Preparation and...

  • Senior Compliance Professional

    2 weeks ago

    Hyderabad City Taluka, Pakistan beBeeCompliance Full time 900,000 - 1,200,000

    We're seeking a seasoned professional to take on a key role in our Compliance Assurance team.Job DescriptionThis position involves leading the execution of the Compliance Assurance assessment plan, ensuring timely and accurate completion of independent assessments. The successful candidate will oversee the quality of work delivered by testing teams, ensuring...

  • Compliance Professional

    2 days ago

    Hyderabad City Taluka, Pakistan beBeeCompliance Full time $100,000 - $140,000

    Job OverviewThis Compliance Officer position plays a pivotal role in ensuring business operations align with relevant laws, regulations, and international standards.Key ResponsibilitiesSupport the design, implementation, and management of IT controls & compliance frameworks for an international organization.Ensure compliance with industry-best security...

  • Senior Compliance Officer

    5 days ago

    Hyderabad City Taluka, Pakistan beBeeRiskAssessment Full time $800,000 - $1,000,000

    Enhanced Due Diligence SpecialistThe role requires a seasoned professional with expertise in risk assessment and mitigation. We are seeking an individual with strong analytical skills, the ability to identify potential threats, and provide actionable recommendations.Main Responsibilities:Conduct comprehensive EDD on high-risk customers, transactions, and...

  • Financial Crime Compliance Specialist

    5 days ago

    Hyderabad City Taluka, Pakistan beBeeFinancialCrime Full time $51,496 - $82,271

    Job Title: Financial Crime Compliance ProfessionalJob DescriptionAs a key member of the Risk Management and Compliance team, you will play a vital role in identifying and mitigating financial crimes. Your primary responsibility will be to investigate and analyze alerts related to Anti-Money Laundering (AML), Terrorist Financing (TF), and Human...

  • Operations Partner Statutory Compliance

    4 days ago

    Hyderabad City Taluka, Pakistan IFFCO Full time

    OverviewThe Operations Partner – Statutory Compliance is accountable for managing end-to-end statutory and labour law compliance at the plant or factory level. This role ensures full adherence to applicable legal and regulatory frameworks, supports HR operational compliance, and oversees administrative functions critical to plant operations. The position...