Lead Quality Assurance Drug Substance- Biologics

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated pure play biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.

Role Purpose

Drug Substance Quality Assurance (QA) Lead Biologics provides strategic and hands-on quality oversight for the manufacture, testing, and release of biologic drug substances (e.g., monoclonal antibodies, recombinant proteins, cell and gene therapy intermediates). The role ensures compliance with global GMP regulations and maintains a state of inspection readiness across internal and external manufacturing operations.

Key Result Areas of the role---

• GMP Oversight of Drug Substance Manufacturing and testing (analytical and Micro related)
• Lead QA oversight of biologics drug substance manufacturing activities & Ensure compliance with ICH guidelines, FDA, EMA, and other global regulations
• Quality Management System (QMS) Leadership
• Oversee implementation and maintenance of QMS elements relevant to DS (deviations, CAPAs, change control).
• Batch Record and analytical records Review and Release Support
• Review Drug Substance batch records, analytical data, and supporting documentation for accuracy, completeness, and compliance.
• Deviation Management
• Lead or approve deviation investigations, ensuring root cause analysis and scientifically sound conclusions.
• CAPA Oversight
• Evaluate, approve, and track CAPAs to ensure effectiveness and timely closure.
• Change Control Evaluation
• Assess proposed changes to processes, equipment, materials, methods, or suppliers for quality and regulatory impact.
• Risk Management
• Apply quality risk management principles (ICH Q9) to Drug Substance processes, deviations, and changes.
• Supplier and Vendor Quality Oversight
• Qualify, audit, and monitor DS suppliers, CMOs, raw material vendors, and contract laboratories.
• Quality Agreements Management
• Develop, review, and maintain Quality/Technical Agreements with Drug Substance manufacturers and vendors.
• Audit Participation and Readiness
• Support and lead internal, external, and regulatory audits (FDA, EMA, PMDA), including inspection readiness.
• Regulatory Compliance Support
• Ensure Drug Substance activities align with regulatory filings (IND, NDA, BLA, DMF) and support regulatory responses.
• Data Integrity Assurance
• Promote ALCOA+ principles and ensure reliable, complete, and traceable DS data.
• Analytical, micro and EM Quality Oversight
• Oversee analytical µ testing, method validation/transfer, OOS/OOT, area excursions investigations related to DS.
• Lifecycle Management of Drug Substance
• Support Drug Substance development through commercial phases, ensuring phase-appropriate GMP compliance.
• Training and Quality Culture Promotion
• Ensure Drug Substance personnel are trained on GMP, SOPs, and quality expectations; foster a strong quality mindset.
• Quality Metrics and Trending
• Monitor quality KPIs (deviations, CAPAs, complaints, audit findings) and perform trend analysis, area trends etc.
• Documentation Control
• Review and approve Drug Substance -related SOPs, protocols, reports, and controlled documents.
• Cross-Functional Collaboration
• Partner with Manufacturing, QC, MS&T, Regulatory Affairs, and Supply Chain teams.
• Complaint and Investigation Support
• Support Drug Substance -related product quality complaint investigations and impact assessments.
• Continuous Improvement Initiatives
• Drive improvements in quality systems, processes, and compliance efficiency.

Annual Product quality reviews (PQR/APQRs) for DS commercial products

Typical Regulatory Frameworks Referenced

• ICH Q7, Q9, Q10
• 21 CFR Parts 210/211
• EU GMP Part II
• WHO GMP for APIs

Looking forward for the aspirants with hands on work experience of 15 to 18 years