Head Quality Assurance

Department:

Reports To:

Position Summary:

Bioanalytical QA

Key Responsibilities:

Quality Leadership & Governance

• Lead end-to-end QA function for India sites covering Bioanalytical QA & Clinical QA.
• Implement and maintain global quality systems, policies and QA frameworks aligned with corporate standards.
• Provide strategic QA direction ensuring alignment with regulatory expectations and global QA vision.
• Drive a strong quality culture and compliance behavior across teams and study functions.

Compliance & Regulatory

• Ensure compliance with

  ICH-GCP, GLP, GCP (Schedule Y), OECD

  , US FDA, EMA, MHRA and other applicable regulatory guidelines.
• Lead inspection readiness and host regulatory / sponsor audits across Indian sites.
• Review and approve QA plans, SOPs, protocols, deviations, CAPA and change controls.
• Continuously evaluate compliance trends, risk areas and implement preventative controls.

Audit & Quality Systems Management

• Oversee internal and external audits and ensure timely closure of audit observations & CAPA.
• Monitor compliance to QA KPIs, quality metrics and governance dashboards.
• Strengthen documentation controls, electronic QA systems and data integrity processes.
• Conduct QA risk assessments and ensure study/process adherence.

People Leadership

• Lead and mentor a team of approx. 50 QA professionals.
• Build QA capability through training, competency development and succession planning.
• Foster a high-performance, ethical and quality-driven team culture.

Stakeholder Collaboration

• Partner with Clinical Operations, Bioanalytical, HR, IT, Regulatory and Business leaders.
• Work closely with Global QA to harmonize processes and share best practices.
• Support business initiatives, key quality projects and strategic expansions.

Qualifications & Experience

• Bachelor or Masters degree in

  Pharmacy

  or related field.

• 15 to 20 years

  of QA experience in

  Clinical Research /CRO / Bioanalytical

  domain.
• Proven experience leading large QA teams & multi-site operations.
• Strong regulatory inspection management experience (US FDA, EMA, MHRA, DCGI etc.).
• Demonstrated expertise in GLP, GCP, OECD, ICH and data integrity standards.

Skills & Competencies

• Strong leadership & people development capability
• Deep knowledge of QA systems & clinical quality frameworks
• Risk-based quality oversight & audit planning
• Excellent communication & cross-functional stakeholder management
• Strategic thinking with execution excellence
• Integrity, transparency and strong ethics

Travel Requirement

• Required to travel at Mehsana sites for QA meetings/initiatives.