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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 pioneering organization focused on enhancing the healthcare environment and positively influencing the lives of individuals. Our commitment lies in innovation, affordability, and ensuring access to superior healthcare solutions.

Role Summary:
  • The Lead Quality Systems position is pivotal in overseeing QMS processes and guaranteeing adherence to regulatory standards.
  • This role entails managing quality system components, facilitating training initiatives, and addressing quality-related challenges.
  • Located in a hybrid work environment, this position reports directly to the Head of Quality for North America.
Key Responsibilities:
  • Evaluate and sanction QMS procedures and methodologies.
  • Detect and rectify quality concerns, formulate CAPA strategies, and lead investigative efforts.
  • Prepare for regulatory audits and maintain compliance with GMP guidelines.
  • Foster relationships with both internal and external stakeholders.
  • Champion risk management projects and promote performance enhancements.
  • Compile quality and compliance data for executive review.
Qualifications and Skills:
  • Bachelor's or Master's degree in Chemistry, Biology, or a related field in life sciences.
  • A minimum of 10 years' experience in overseeing quality systems within pharmaceutical settings.
  • Proficient in regulatory audits and GMP compliance.
  • Exceptional attention to detail and strong communication abilities.
  • Capable of leading and inspiring teams, functioning within a matrix organization, and establishing 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 evaluated without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.