Site Head Quality Assurance

Position Title

Position Overview

General Manager – Quality Assurance

Key Responsibilities

1. Site Quality Leadership

• Lead, manage, and enhance all QA operations for both Injectable and OSD manufacturing blocks.
• Establish and maintain a robust Quality Management System (QMS) aligned to cGMP, USFDA, EU GMP, WHO, TGA, and other regulatory expectations.
• Act as Management Representative (MR) for quality during internal, external, and regulatory inspections.

2. Compliance Management

• Ensure site-wide compliance with global regulatory requirements and internal SOPs.
• Oversee audit readiness and lead all regulatory inspections (USFDA, EU GMP, MHRA, WHO, ANVISA, TGA, etc.).
• Drive effective and timely closure of audit observations, CAPA management, and compliance enhancements.

3. Quality Management System (QMS) Ownership

• Oversee deviation management, change controls, CAPA systems, risk assessments, investigations, and batch release processes.
• Manage document control, master batch records, validation protocols, and ensure timely periodic reviews.
• Drive continuous improvement initiatives for QMS strengthening and operational excellence.

4. Batch Release and Product Quality Oversight

• Ensure timely review and approval of Batch Manufacturing Records (BMRs), Quality Control reports, and Certificates of Analysis (CoAs).
• Provide QA release for commercial and validation batches, including product quality review and compliance verification.

5. Training and Development

• Establish training programs on GMP, GDP, Data Integrity, and regulatory updates for all QA and cross-functional teams.
• Build quality culture across the site through continuous learning initiatives and behavior-based quality systems.

6. Cross-functional Collaboration

• Partner closely with Manufacturing, Engineering, QC, Regulatory Affairs, Supply Chain, and Corporate Quality teams to ensure seamless compliance operations.
• Provide strategic QA inputs during tech transfer, scale-up, validation, and commercialization of new products.

7. Risk Management (QRM) and Continuous Improvement

• Lead site risk assessments and mitigation initiatives to proactively address quality and compliance risks.
• Drive operational excellence projects focused on quality improvement, waste reduction, and right-first-time culture.

8. Data Integrity and Electronic Systems Compliance

• Ensure robust data governance, ALCOA+ compliance across all electronic systems like LIMS, TrackWise, SAP-QM, Document Management Systems.
• Conduct periodic data integrity audits and gap assessments.

9. Project Management Skills

• Exhibit excellent project management skills with respect to New Projects & New Product Introduction at site
• Work closely with R&D and RA Teams for timely execution of each project for Execution of Exhibit/ Validation batches, documentation & review to facilitate submissions.

10. Qualifications & Validations

• Ensure effective coordination with validation teams for timely execution of qualifications, re-qualifications & periodic re-qualifications
• Ensure Process Validation & Cleaning Validations are in line with current regulatory expectations

Key Requirements

Criteria

Expectations

Experience

Minimum 20+ years in Pharma QA with injectable and OSD background mandatory

Regulatory Handling

Direct exposure to inspections by USFDA, EU GMP, MHRA, WHO, etc. essential

Quality Systems Expertise

Strong QMS management, deviation/investigation handling, and risk-based thinking

Leadership and Team Management

Proven experience leading large QA teams across multiple dosage forms

Communication and Collaboration

Ability to interact with regulatory bodies, external auditors, and internal teams effectively

IT Literacy

Familiarity with SAP-QM, LIMS, electronic document control systems preferred