Quality Manager

Job Title: Quality Assurance ManagerLocation: Mumbai- SakinakaDepartment: Quality AssuranceReports To: FounderEmployment Type: Full-timeJob purpose – The Quality Assurance Manager is responsible for overseeing the quality systems andregulatory compliance programs within a pharmaceutical distribution environment. This role ensuresthat all products handled and distributed meet applicable regulatory requirements (e.g., FDA, DEA,cGMP, GDP), company standards, and customer expectations.Key ResponsibilitiesDevelop, implement, and maintain the Quality Management System (QMS) inaccordance with current Good Distribution Practices (GDP) and applicable regulatoryrequirements.Ensure compliance with all federal, state, and local regulatory requirements, includingFDA.Lead and manage internal and external audits, regulatory inspections, and customeraudits.Conduct risk assessments and implement corrective and preventive actions (CAPAs)to address non-conformances and audit findings.Oversee the documentation control system, including SOPs, change controls,deviations, and quality records.Develop and deliver training programs on quality and compliance topics forwarehouse and distribution staff.Manage product complaints, returns, recalls, and investigations.Collaborate with warehouse and operations teams to ensure adherence to producthandling, storage, and transportation standards.Monitor quality metrics and generate reports for senior management.Review and approve batch documentation, temperature excursion reports, andrelease authorizations.Maintain current knowledge of industry regulations and standards and providestrategic input on quality improvement initiatives.QualificationsEducation:Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field required.Experience8+ years of experience in quality assurance within pharmaceutical, biotech, orhealthcare distribution.Knowledge of FDA regulations, GDP, cGMP, and other applicable quality standards.Experience with regulatory inspections and compliance audits.Experience with controlled substances handling is a plus.Working ConditionsPrimarily office-based with monthly/quarterly visits to branches.May require occasional travel for audits, inspections, or training.Skills: fda, dea, cgmp, gdp,compliance,regulatory requirements,quality assurance