Senior Executive, Compliance

ADVANZ PHARMA

Senior Executive in Quality Compliance ensuring Contract Manufacturing Organizations meet pharmaceutical standards and best practices. Collaborating with regulatory bodies to uphold compliance and quality assurance processes.

Posted 6/16/2026full-timeRemote • 🇮🇳 IndiaSeniorWebsite

About the role

Key responsibilities & impact

Owning Compliance related change controls pertaining license updates and ensuring such changes are progressed and closed within timelines.
Establishing business and Quality needs and criticality for identified license non-compliances and closing license gaps as dictated by this information.
Writing supporting Quality related submission documents, as necessary.
Managing workload appropriately with the ability to re-prioritize rapidly as necessary.
Liaising with Regulatory routinely to ensure submission priorities are aligned and quality critical submissions are prioritized.
Reviewing and approving critical Module 3 documents written by Regulatory prior to submission to ensure content is CTD compliant.
Managing associated submission RFIs within timeframe.
Quality Compliance owner for Technical Transfers projects, involving performance of gap assessment between prospective CMO and current registered information and working toward established project timelines.
Liaising with external stakeholders including Contract Manufacturing Organizations and building key relationships.
Quality Compliance SME for Projects owned by both the Compliance team and other departments.

Requirements

What you’ll need

Minimum Degree in Chemistry, Pharmacy or Microbiology
Minimum 5 years' experience of working in a similar role within a pharmaceutical industry
Extensive GxP knowledge across all dosage forms
Experience in authoring Module 3 in CTD format
Experience in interpreting manufacturing and testing information (Critical Vs. Non-critical) for submission purpose
Experience in ensuring that accurate, adequate and appropriate data is incorporated in Module 3 so as to ensure right first submissions
Experience in writing supporting submission documents (e.g. justifications to support post marketing changes and response (to RFI)
Extensive knowledge of QMS, specifically change controls and risk assessments, and continuous improvements
Capable of working to deadlines & remain calm under pressure
Proven ability to organize and prioritize multiple tasks
Ability to work effectively as part of a team and cross functionally

Benefits

Comp & perks

Competitive salary
Flexible working environment

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GxP knowledgeModule 3 authoringCTD formatQuality Management System (QMS)change controlsrisk assessmentsgap assessmentsubmission documents writingdata interpretationsubmission RFIs management

Soft Skills

ability to prioritizecalm under pressureorganizational skillsteamworkcross-functional collaborationcommunication skillsrelationship buildingworkload managementadaptabilityproblem-solving

Certifications

Degree in ChemistryDegree in PharmacyDegree in Microbiology