Quality Assurance- Head

3 days ago

Prahlad Nagar Ahmedabad Gujarat, India f5680d33-d2cb-4631-9907-ce9558b5905d Full time ₹ 18,000 - ₹ 35,00,000 per year

The Head – QA (India) will lead and oversee Quality Assurance functions covering Bioanalytical QA and Clinical Research QA operations. This role ensures compliance with global quality standards, regulatory requirements, GCP/GLP and internal quality systems while strengthening a culture of quality, continuous improvement, and operational excellence. The role acts as the primary QA leadership point in India and collaborates closely with global QA leadership..

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 Master's degree in Pharmacy or related field.
  • 12–18 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

Job Types: Full-time, Permanent

Pay: ₹1,500, ₹3,500,000.00 per year

Benefits:

  • Cell phone reimbursement
  • Flexible schedule
  • Food provided
  • Health insurance
  • Leave encashment
  • Paid sick time
  • Provident Fund

Work Location: In person

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