Role: Head Quality

Location: Bangalore

Dosage Form: OSD

Interested can share their profile on [email protected]

Lead the overall Quality function covering QA, QC, Microbiology, Analytical Services, Validation, IPQA and QMS for a commercial pharmaceutical manufacturing workplace. The role will drive quality strategy, regulatory compliance, scientific excellence, inspection readiness, quality culture and continuous improvement across the site.

Key Responsibilities

1. Quality & QA Leadership

· Lead overall Quality strategy and ensure compliance with cGMP, ICH, pharmacopoeial and global regulatory requirements. · Provide Quality oversight for manufacturing, technology transfer, NPI, scale-up and product lifecycle activities.

· Drive Quality Risk Management, product quality and continuous improvement across the site.

1. QC, Microbiology & Analytical Services

· Lead Chemical QC, Microbiology and Analytical Services covering RM, PM, IP, FP and stability testing. · Oversee analytical method validation, verification, transfer, stability, troubleshooting and lifecycle management.

· Ensure effective management of OOS/OOT, deviations, investigations, CAPA and laboratory compliance.

· Drive laboratory efficiency, data integrity, digitalization and inspection readiness.

1. Validation & IPQA

· Provide leadership for process, cleaning, analytical and equipment/facility validation, including qualification and lifecycle management. · Oversee IPQA activities across dispensing, granulation, blending, compression, coating,



encapsulation and packing.

· Ensure effective control of CPPs, in-process controls, batch quality, deviations and process robustness.

1. QMS & Compliance

· Own and strengthen the site Quality Management System, including Deviations, CAPA, Change Control, OOS/OOT, Complaints, PQR, QRM, SOPs and training. · Drive root-cause analysis, risk-based CAPA and timely closure of quality actions.

· Ensure strong Data Integrity / ALCOA+ / 21 CFR Part 11 practices.

1. Regulatory & Customer Audits

· Lead site readiness and responses for USFDA, EMA/EU, MHRA, PIC/S and customer audits. · Drive remediation, inspection commitments and sustainable compliance improvements.

· Act as senior Quality interface with global customers and cross-functional stakeholders.

1. OSD & Technical Quality Leadership

· Strong understanding of commercial OSD manufacturing – tablets, capsules, granulation, compression and coating. · Provide Quality leadership for technology transfer, scale-up, process validation and commercialization.

· Exposure to complex / high-potency OSD products will be an advantage.

1. People & Strategic Leadership

· Lead a large multidisciplinary team across QA, QC, Microbiology, Analytical, Validation, IPQA and QMS. · Build strong second-line leadership, succession plans and technical capability.

· Own Quality KPIs, manpower planning, budgets and CAPEX.

· Partner with Manufacturing, R&D;, Engineering, Regulatory, Supply Chain and global teams.

📌 Senior GM/AVP (Bengaluru)
🏢 Medulla Recruitment Services
📍 Bengaluru