Director/Lead, Quality & Compliance at Dr. Reddy's Laboratories, Inc. in Princeton, New Jersey

Posted in Other 3 days ago.





Job Description:

Description



Position at Dr. Reddy's Laboratories, Inc.


By joining Dr. Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.

We have an opening for a Lead, Quality & Compliance in our Princeton, NJ office (currently remote).

This position will provide an independent oversight of Analytical Quality and compliance for Quality Control Laboratories across North American Internal and External sites in alignment with federal regulatory requirements; Provide direction, support and guidance to ensure effective use of Analytical Quality Control procedures, policies and systems.

Primary responsibilities include:


  • Manage Regional Internal & External Laboratory Audits, Supplier Quality Management. Conduct Laboratory GAP Assessments and provide Laboratory Compliance Expertise.

  • Provide quality leadership for Analytical quality control projects and base business support to ensure compliance to the organizational and regulatory standards.

  • Provide guidance for product robustness, deploy training of regional quality control procedures in collaboration with Business unit quality groups.

  • Ensure Data review controls across North America region including inspection readiness and resolutions.

Education & Experience:

  • A minimum of a bachelor's degree (chemistry/ microbiology, or science) is required

  • 12- 15 years of experience in a Quality Assurance/Quality Control role in Bio-Pharmaceutical regulated environment.

  • Experience and working knowledge in Analytical R&D quality, quality control/QA and related quality systems.

  • Supervisory experience and sound knowledge of Quality Control, data integrity and data review experience.

  • Proven record in support of GMP Quality control and Analytical R&D quality.

  • Knowledge of Quality Risk Management principles



Equal Opportunity Employer: Minorities/Women/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.