Head of Quality Systems Management

1 week 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 sector and positively influencing lives. Our commitment lies in innovation, affordability, and ensuring that quality healthcare solutions are accessible to all.

Role Summary:
  • The Lead Quality Systems position is accountable for overseeing Quality Management System (QMS) processes and ensuring adherence to regulatory standards.
  • This role involves managing essential quality system components, directing 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 authorize QMS procedures and workflows.
  • Detect and rectify quality challenges, formulate Corrective and Preventive Action (CAPA) plans, and facilitate thorough investigations.
  • Prepare for regulatory audits and maintain compliance with Good Manufacturing Practices (GMP).
  • Foster relationships with both internal and external stakeholders.
  • Lead initiatives in risk management and enhance operational performance.
  • Compile quality and compliance metrics 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 of experience in managing quality systems within pharmaceutical environments.
  • Proven experience with regulatory audits and GMP compliance.
  • Exceptional attention to detail and strong communication abilities.
  • Capability to lead and inspire teams, navigate a matrix organization, and establish clear objectives.
  • Must possess authorization to work in the U.S. without sponsorship.
COVID-19 Vaccination Policy:

Dr. Reddy's encourages all employees to receive vaccinations to mitigate the spread of COVID-19. While vaccinations are not mandatory, 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.

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