Assistant Manager - Operational Quality

Job description

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, theres no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. As an **Assistant Manager – Operational Quality**, you will lead the on-site QA function supporting capsule manufacturing operations. You will ensure real-time GMP compliance across IPQA, validation, batch review and release, deviation and CAPA management, document control, and SAP master data governance. This role plays a critical leadership position in maintaining regulatory readiness and driving quality excellence within operations. **What you’ll get** - An agile career and dynamic working culture. - An inclusive and ethical workplace. - Compensation programs that recognize high performance. - Opportunities to lead a QA team in a regulated GMP manufacturing environment. The full list of our global benefits can be found at: https://www.lonza.com/careers/benefits **What you’ll do** - Lead the IPQA team to ensure real-time GMP compliance during capsule manufacturing operations, including line clearance, in-process controls, documentation review, sampling, and AQL inspections. - Provide on-floor quality decision-making during deviations and critical manufacturing activities. - Own and govern the Validation Master Plan (VMP) and ensure execution of equipment qualification (IQ/OQ/PQ) and process validation activities. - Review and approve validation protocols and reports in alignment with GxP, WHO-GMP, and Schedule M requirements. - Ensure timely batch record review, disposition, and release readiness. - Lead deviation investigations, perform robust root cause analysis, and ensure effective CAPA implementation and closure. - Oversee control sample management and document control systems (WOPs, validation records, electronic documentation). - Ensure SAP master data governance (item codes, BOMs, material attributes) is accurate and compliant with approved procedures. - Compile and review Annual Product Quality Reviews (APQR), analyze trends, and recommend continuous improvement initiatives. - Support audits and inspections (customer, regulatory, third-party), ensuring documentation readiness and compliance responses. - Drive quality improvement initiatives and support Operational Excellence programs. **What we’re looking for** - Bachelor’s degree in pharmacy (B. Pharm) or relevant life sciences discipline. - Experience in Quality Assurance within a regulated pharmaceutical or life sciences manufacturing environment. - Strong knowledge of cGMP, GDP, ICH guidelines, and regulatory compliance standards. - Proven experience in IPQA, qualification & validation, deviation/CAPA management, and batch review. - Experience leading teams in a manufacturing environment (direct people management preferred). - Demonstrated analytical, documentation, and problemsolving skills. - Ability to make sound quality decisions in real-time production environments. - Effective communication skills in English and Hindi.