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Head of Quality Systems Management

2 months ago


Princeton, New Jersey, United States Dr. Reddy's Laboratories Full time
Position Overview:

Dr. Reddy's Laboratories Inc. is a forward-thinking organization focused on enhancing the healthcare sector and positively influencing lives. The company prioritizes innovation, affordability, and accessibility to high-quality healthcare solutions.

Role Summary:
  • Oversee the Quality Management System (QMS) processes, ensuring adherence to regulatory standards.
  • Key duties include managing quality system components, implementing training initiatives, and addressing quality challenges.
  • This position is based in Princeton, NJ, following a hybrid work structure, and reports directly to the Head of Quality for North America.
Key Responsibilities:
  • Evaluate and authorize QMS procedures and protocols.
  • Detect and rectify quality challenges, formulate Corrective and Preventive Action (CAPA) plans, and lead investigations.
  • Prepare for regulatory audits and maintain compliance with Good Manufacturing Practices (GMP).
  • Foster relationships with both internal and external stakeholders.
  • Champion risk management projects and enhance performance metrics.
  • Compile quality and compliance data for management assessment.
Qualifications and Skills:
  • Bachelor's or Master's degree in Chemistry, Biology, or a related field in life sciences.
  • A minimum of 10 years of experience in quality systems management within pharmaceutical environments.
  • Proven experience with regulatory audits and GMP compliance.
  • Strong attention to detail and excellent communication abilities.
  • Capability to lead and inspire teams, navigate a matrixed environment, and establish clear goals.
  • Must possess authorization to work in the U.S. without sponsorship.
COVID-19 Vaccination Policy:

Dr. Reddy's encourages all personnel to receive vaccinations to mitigate the spread of COVID-19. While vaccinations are not mandatory at this time, unvaccinated employees are required to undergo weekly COVID testing.

Commitment to Diversity:

Dr. Reddy's is an Equal Opportunity Employer, and all qualified candidates will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.