1. Role Purpose

The Vice President – Central Quality Head will provide strategic and enterprise-wide leadership for the Quality function across the organization's Pharmaceutical and Biopharmaceutical/Biosimilars businesses .

The incumbent will be responsible for establishing and driving a robust, harmonized and globally benchmarked Quality Management System , ensuring compliance with applicable regulatory requirements, strengthening quality culture, and enabling business growth while maintaining the highest standards of patient safety, product quality, data integrity and regulatory compliance .

The role will serve as the central authority and strategic custodian of Quality , providing governance and oversight across manufacturing sites, R&D;, analytical development, quality control, quality assurance, supply chain, contract manufacturing and other GxP functions.

The position will also act as a key member of the Executive Leadership Team , partnering with Business, Manufacturing, R&D; and Regulatory leaders to embed Quality by Design and Quality Risk Management principles across the product lifecycle. ICH Q10 specifically emphasizes management responsibility, CAPA, change management, product/process monitoring and management review as core elements of an effective pharmaceutical quality system.

2. Key Responsibilities

A. Enterprise Quality Strategy & Governance

- Develop and implement the enterprise-wide Quality strategy and roadmap for Pharma and Biopharma businesses.
- Establish a consistent Corporate Quality Governance framework across all manufacturing and R&D; locations.
- Define Quality policies, standards, governance mechanisms, metrics and objectives aligned with business strategy.
- Establish a single Quality culture and operating philosophy across sites and business units.




- Provide independent Quality oversight and challenge to business and operational decisions where product quality or patient safety may be impacted.
- Chair/lead appropriate Corporate Quality Review and Management Review forums .
- Provide periodic Quality performance updates, risk assessments and strategic recommendations to the Executive Management Team/Board.

B. Quality Management System

- Own and continuously strengthen the organization's Pharmaceutical Quality System (PQS) across Pharma and Biopharma.
- Harmonize corporate SOPs, policies, standards and quality processes across sites.
- Drive maturity of:
- Deviation Management
- CAPA
- Change Control
- OOS/OOT Management
- Product Quality Reviews/APQR/PQR
- Complaints
- Recall Management
- Quality Risk Management
- Supplier Quality
- Audit Management
- Data Integrity
- Training and Qualification
- Document Management

- Establish effective Quality Metrics and Quality KPIs , including leading indicators and risk-based measures.
- Drive continuous improvement and quality-system effectiveness.

ICH Q10 identifies the PQS as a lifecycle-based system applicable to both conventional pharmaceutical and biotechnology/biological products.

C. Regulatory Compliance & Inspection Readiness

- Provide enterprise leadership for regulatory compliance and inspection readiness across all sites.
- Ensure preparedness for inspections/audits by agencies such as:
- US FDA
- EMA/EU authorities
- MHRA
- PMDA
- WHO
- CDSCO/DCGI
- Other applicable global health authorities.

- Lead corporate oversight of critical regulatory inspections and ensure appropriate preparation, response and remediation.
- Review and approve strategic responses to critical/major regulatory observations .

Establish a robust inspection-readiness framework across all manufacturing and R&D; locations.

📌 Vice President- Central Quality (Mumbai)
🏢 Talental Consultings
📍 Mumbai