Associate Manager (Quality Assurance – Operations/ Compliance/ Investigations)
Core
Independent management, review, and approval of Quality Assurance activities to ensure cGMP compliance, lead investigations, and drive regulatory readiness for sterile dosage manufacturing.
Role type
Associate Manager, Quality Assurance (Operations/Compliance/Investigations)
Builds
Quality systems, regulatory compliance, and investigation outcomes for sterile dosage manufacturing facilities.
Domain
Pharmaceutical manufacturing / Biotech / Quality Assurance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Manufacturing process knowledge, validation activities, technical document review, change control, risk assessment, chemical and microbiological testing, root cause analysis, regulatory inspection handling
Preferred skills
Cross-functional relationship building, effective communication at all organizational levels, compliance-driven approach, experience with national and international inspections (USFDA, MHRA, TGA, WHO)
Technologies
Change Management processes, Risk assessment tools, Lab equipment validation systems, Drug Product Process validation systems
Responsibilities
Review and approve QC documents, batch records, validation protocols, SOPs, specifications, and stability reports; Ensure implementation of Quality Management Systems (Change Control, CAPA, Deviations); Lead audit and inspection readiness activities; Lead, review, and approve deviation investigations and CAPA; Provide technical guidance and mentoring to junior team members
Seniority
Associate Manager, hands-on IC with leadership responsibilities