Quality Head

Job Description:

Job Title: Quality Head (Biosimilars, Insulin & Dry Powder Formulations)

Department: Quality Assurance

Location: Bhopal

Reports To: Plant Head / Corporate QA Head

Position Summary:

Eris Lifesciences is looking for a seasoned Head – Quality Assurance to lead QA operations for its biotech and sterile manufacturing unit, specializing in biosimilars, insulin, vaccines, monoclonal antibodies (MABs), and dry powder injectable formulations. This strategic role involves ensuring adherence to global cGMP standards, regulatory compliance, robust QMS, and product quality across the product lifecycle. The candidate must have strong leadership skills and extensive experience in both biological and sterile dry powder environments.

Key Responsibilities:

• Head QA operations across manufacturing units handling biosimilars, insulin, vaccines, MABs, and dry powder formulations.
• Ensure compliance with WHO-GMP, USFDA, EU-GMP, CDSCO, and other international regulatory guidelines.
• Lead batch release, change control, deviation investigations, CAPA implementation, and market complaint handling.
• Oversee quality systems for aseptic processing, biotech fermentation, and lyophilized/dry powder injectable manufacturing.
• Drive and maintain a comprehensive Quality Management System (QMS) across the site.
• Conduct internal audits, face regulatory inspections, and ensure timely closure of observations.
• Review and approve SOPs, validation protocols, process qualifications, and batch manufacturing records.
• Collaborate with Production, QC, Regulatory Affairs, and R&D for product launches and tech transfers.
• Provide strategic input on continuous improvement, risk assessments, and regulatory submissions.
• Foster a quality culture through training, coaching, and compliance monitoring of QA personnel.

Qualifications & Experience:

• M.Pharm / B.Pharm / M.Sc. (Biotechnology / Microbiology / Chemistry)
• 15+ years of progressive experience in QA, including:
• Biosimilars (insulin, MABs, vaccines)
• Sterile injectable and aseptic manufacturing
• Dry powder injectable formulations (e.g., lyophilized products)
• At least 5 years in a leadership role in a regulated pharmaceutical/biotech environment

Key Skills & Competencies:

• In-depth understanding of biologics, dry powder technology, and sterile manufacturing
• Regulatory expertise (USFDA, EMA, WHO-GMP, CDSCO)
• Strong command of data integrity, validation life cycle, and document control systems
• Capable of handling cross-functional QA leadership and multi-product manufacturing setups
• Excellent problem-solving, communication, and audit management skills

If you are interested for this opening please send updated resume on same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-