Senior Development QA Manager at Sandoz

Overview

Sandoz is seeking a Senior Development QA Manager based in Telangana, India. This role involves leading and managing a QA organization to ensure compliance with regulatory and health authority requirements. The position requires extensive experience in quality management, regulatory compliance, and risk management within the pharmaceutical industry.

Key Responsibilities

• Provide QA expertise to ensure compliance with quality system requirements, including quality risk-based and GxP-relevant processes.
• Lead and manage QA teams, collaborate with business partners and quality groups to meet health authority and regulatory requirements.
• Translate functional QA strategy into operational activities, support risk-based process implementation.
• Address quality and compliance gaps, implement strategic process improvements, and ensure sustainability.
• Monitor Quality Plan implementation and support inspection readiness activities.
• Manage quality oversight of external service providers and IT systems, handle audits and inspections, and ensure completion of corrective actions.
• Ensure timely escalation and quality oversight of deviations/incidents, conduct robust investigations and root cause analysis.
• Contribute towards lessons learned from audits, inspections, incidents, and regulatory intelligence to promote a proactive, risk-based culture.
• Report technical complaints, adverse events, or special case scenarios related to Sandoz products within 24 hours.
• Distribute marketing samples as applicable.

Requirements

Essential:

• Bachelor’s degree in life/physical science (chemistry, biology, microbiology, pharmacy, biochemistry).
• 18+ years of experience in people leadership, operations management, and project management.
• Proficient in English, both written and spoken.
• Experience in collaborating across boundaries, critical negotiations, industry/business exposure, and vendor management.
• Knowledge of TQM, GxP standards, quality management, and risk management.

Desired:

• Postgraduate degree in Pharmacy or equivalent.
• Knowledge of pharmaceutical development, analytical development, GMP, CAPA, six sigma, and regulations & guidelines.
• Skills in creativity and visioning, influencing and persuading, and risk management.

Skills

• Familiarity with health authorities and pharmaceutical development.
• Creativity and visioning.
• Analytical development.
• GMP knowledge.
• CAPA knowledge.
• Influencing and persuading.
• Six Sigma.
• Risk Management.
• Quality Management.

Why Sandoz?

Sandoz is a leader in the generic and biosimilar medicines industry, reaching nearly 500 million patients annually. With investments in development, state-of-the-art production sites, acquisitions, and partnerships, Sandoz is positioned to shape the future of medicine by providing high-quality, low-cost medicines sustainably.

Commitment to Diversity & Inclusion

Sandoz is dedicated to building an inclusive work environment and diverse teams representative of the patients and communities they serve. They encourage applications from diverse backgrounds and provide opportunities for personal and professional growth.

Application

To apply or learn more about this opportunity, visit the Sandoz career page and search for Job ID: 394291BR. If this role doesn’t match your experience or career goals, you can join the Sandoz Talentpool to stay connected for future opportunities.