Head - Quality/Sterile Operations - Pharma
Posted 2 weeks ago
Posted 2 weeks ago
Head of Quality (Sterile Operations) - Top Pharma Company
Description:
Location: Nalagarh
Position: Head Quality (QA/QC/Microbiology)
Experience: 15 to 18+ years in Pharmaceutical Quality with 57 years in sterile/aseptic leadership
Qualification: M.Pharm / M.Sc. / MBA (Quality/Regulatory) + GMP/QMS certifications preferred
About the Role
We are hiring a senior Quality leader to head QA, QC, and Microbiology operations for our sterile ophthalmic manufacturing site. This role ensures complete compliance with global regulatory standards (USFDA, EU GMP, MHRA, ANVISA, TGA), drives site audit readiness, leads critical investigations/CAPAs, and ensures smooth execution of all Quality Management System (QMS) elements. The incumbent will lead a large team, strengthen GMP culture, and ensure consistent delivery of high-quality sterile products.
Key Responsibilities
- Lead Quality (QA/QC/Microbiology) for a sterile drug facility; ensure end-to-end compliance with global regulatory agencies.
- Maintain continuous site readiness for USFDA, MHRA, EU GMP, ANVISA, TGA & customer audits.
- Drive effective QMS executionchange controls, risk assessments, deviations, CAPA, OOS, complaints, recalls.
- Lead robust investigations and on-time closure of all investigation-related actions.
- Oversee aseptic operations, cleanroom controls, environmental monitoring, and sterile area GMP practices.
- Ensure process validation, aseptic media fills, cleaning validation, calibration, equipment qualification, and CSV compliance.
- Maintain QC/Microbiology laboratory compliance, analytical method validation, data integrity & documentation control.
- Lead batch release/rejection as per regulatory filings and market-specific requirements.
- Guide a 100+ member Quality team; drive capability building, training, and GMP culture enhancement.
- Participate in Quality Governance, product/process reviews, and drive continuous improvement initiatives.
- Act as Management Representative for ISO 13485 & EU-MDR compliance.
What Were Looking For
- Strong exposure to sterile/aseptic manufacturing operations.
- Hands-on experience handling global regulatory inspections with positive outcomes.
- Deep knowledge of ophthalmic dosage forms (solutions, suspensions, emulsions).
- Ability to lead large teams and drive strong Quality culture.
- Strong analytical thinking, problem-solving, and decision-making capability.
Why Join Us?
- Lead quality for a global-compliance sterile manufacturing site.
- High visibility role with direct impact on regulatory success and product quality.
- Opportunity to lead, develop, and build a high-performance Quality organization.
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