This job offer is not available in your country.

QA Compliance Lead

ConfidentialPune, Mumbai

18 hours ago

Job description

Lead Global QA Policies : Take the lead in generating global Quality Assurance policies, offering guidance on regulatory interpretation and application. Influence internal practices and ensure policies align with evolving regulations.

Subject Matter Expertise : Provide in-depth expertise on niche regulatory topics, offering guidance to internal teams, clients, and regulatory authorities. Serve as the point of contact for regulatory audits and inspections.

External Audits / Inspections : Host and lead external audits, including regulatory inspections, strategic client audits, and country-specific inspections. Ensure timely and comprehensive responses to audit findings.

Quality Metrics Continuous Improvement : Oversee the reporting of quality metrics and coordinate the implementation of corrective actions. Lead initiatives aimed at improving compliance and efficiency through process improvements.

Quality Initiatives : Manage and participate in global Quality initiatives designed to enhance QA practices and improve organizational efficiency.

Support QA Manager : Act as a backup for the QA Manager, ensuring all QA responsibilities are met. Provide monthly activity reports and support other QA activities as needed.

Compliance Monitoring : Ensure all Regulatory Compliance and Quality Assurance (RCQA) responsibilities are followed in accordance with controlled documents and industry standards.

Additional Duties : Perform other QA-related duties as assigned by management, contributing to the success of the broader organization.

Experience : Minimum of 8 years of experience in the regulatory environment, particularly in GXP roles (Good Clinical, Good Manufacturing, Good Laboratory Practices).

Expertise in regulatory requirements , with detailed knowledge of specific regulations (or multiple regulations) and their application to clinical research.

Experienced Lead Auditor , capable of managing external audits and inspections, and ensuring compliance with regulatory standards.

Proven track record of strategic communication with clients and regulatory authorities.

Strong background in leading process improvement initiatives and driving continuous quality enhancements within organizations.

Qualifications : Minimum Required :

A Bachelor s Degree in Pharmacy, Chemistry, Biology, or a related field.

Postgraduate degree (MSC or equivalent) in a science or management-related discipline is preferable but not required.

Equivalent professional experience may substitute educational requirements.

Desirable Skills :

Strong leadership abilities, particularly in managing cross-functional teams.

Excellent communication and interpersonal skills to effectively engage with clients and regulatory bodies

Skills Required

Pharmacy, Chemistry, Biology, Interpersonal

Create a job alert for this search

Qa Lead • Pune, Mumbai

Related jobs

Promoted

Module Lead

IDfymumbai, maharashtra, in

IDfy is Asia’s leading TrustStack, trusted by the best.With global expertise and enterprise-grade tech, we’re solving trust challenges, making compliance easy, fraud detection smarter, and onboardi...Show moreLast updated: 30+ days ago

Promoted

Senior Compliance Specialist

CESKalyan-Dombivli, IN

Senior Compliance Analyst / Team Lead / AM / Manager and I think you could be a good fit.We are looking for 5+ years of experience in Compliance - Code of Ethics, I’d like to tell you a little more abou...Show moreLast updated: 18 days ago

Promoted

Compliance Manager / Lead

ConfidentialMumbai

Preparation delivery of compliance review testing plan.Independently concludes on the effectiveness of controls through the review and monitoring. Communication of control issues and related recomme...Show moreLast updated: 8 days ago

Promoted

Quality Assurance Lead

BrightEdgeDombivali, Maharashtra, India

BrightEdge is a global leader in enterprise SEO and content performance solutions, driving AI-powered digital marketing success for the world’s top brands. Our culture is product-first, innovation-d...Show moreLast updated: 30+ days ago

Promoted

SAP Signavio Lead

RialtesThane, IN

We’re Hiring : SAP Signavio SME (Remote / Contract).We’re looking for an experienced.SAP Signavio Subject Matter Expert.Lead and guide clients on SAP Signavio adoption for S / 4HANA transformations.Driv...Show moreLast updated: 30+ days ago

Promoted

Test Lead

QualityKiosk Technologies Pvt. Ltd.Mumbai, Maharashtra, India

QualityKiosk Technologies is one of the world's largest independent Quality Engineering (QE) providers and digital transformation enablers, helping companies build and manage applications for optim...Show moreLast updated: 25 days ago

Promoted

OpenLink Endur Findur QA (Consultant / Senior / Principal Consultant)

KWA AnalyticsMumbai, IN

About KWA Analytics : We are a global organisation offering a comprehensive range of consulting services for trade lifecycle management to clients involved in energy, commodities, shipping, treasury...Show moreLast updated: 18 days ago

Promoted

Deputy Manager-QA

ConfidentialMumbai, India

Ensure all the computerized systems meeting the 21 CFR Part 11, EU ANNEX 11and GAMP5 guidelines requirements.Perform, review & approve computerized system validation life cycle deliverables.Respons...Show moreLast updated: 8 days ago

Promoted

Global Compliance Lead - India

ConfidentialMumbai, India

MACN is hiring for a newly established compliance lead role that combines global strategic leadership with local hands-on project delivery. The role can also be based in other locations in India.The...Show moreLast updated: 8 days ago

Promoted

Audit Compliance

ConfidentialMumbai

Experience in IS Audit and Implementation.Exposure to ISO20000 / SSAE-18 / SOX-ITGC / PCIDSS / GDPR.Must have worked in IS / IT Risk Management. Must have any one of the Certifications CISA / CISM / CRISC and ISO...Show moreLast updated: 20 days ago

Promoted

Guidewire Claim center QA

Zensar TechnologiesThane, IN

GW CC QA is committed to delivering high-quality software solutions and fostering a culture of innovation and collaboration. The role involves testing and quality assurance for Claim Center, ensurin...Show moreLast updated: 17 days ago

Promoted

Manager, QA (IC role)

ConfidentialMumbai, India

Manages and ensures proper execution of the audit and inspection programs.Oversees designated global audit programs for compliance with the master audit plan, (procedures, execution, QC, compliance...Show moreLast updated: 8 days ago

Promoted

Lead Regional Compliance Specialist

Securitas GroupDombivali, Maharashtra, India

Job title : Lead Regional Compliance Specialist - APAC Location : India – open to Chennai / Hyderabad / Pune About our team We are a dynamic, dedicated team that provides management and support for a...Show moreLast updated: 25 days ago

Promoted

Site QA / AT Lead

ConfidentialMumbai

We are seeking a detail-oriented and experienced Site QA / AT (Quality Assurance / Acceptance Testing) Lead to oversee and ensure quality standards and acceptance protocols at telecom / infrastructure ...Show moreLast updated: 11 days ago

Promoted

QA Lead

ConfidentialMumbai

Lead the design, development, and execution of automated test scripts for Flutter mobile applications, ensuring comprehensive test coverage. Implement and maintain automated testing frameworks and t...Show moreLast updated: 19 days ago

Promoted

Lead QA Engineer

ConfidentialMumbai

Python, QA Data Automation, ETL, SQL.Selenium or Web or API testing.SQL, Python, ETL knowledge, QA test case, test planning. Strong technical knowledge of SQL and writing testing scripts in Python t...Show moreLast updated: 30+ days ago

Promoted

QA Specialist

Insight GlobalThane, IN

Experience with manual web-application testing across Window and Android.Selenium, Playwright or Cypress.Scripting and programming experience in Python, Bash, or PowerShell.Understanding of REST / JS...Show moreLast updated: 7 days ago

Promoted

Technical Lead

Cogitatenavi mumbai, maharashtra, in

Property & Casualty Claims Management System.This role requires a hands-on technical expert who is equally comfortable with architecture and coding as they are with leading a team.The ideal candida...Show moreLast updated: 30+ days ago