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Lead, Quality

Company: Dr. Reddy's Laboratories, Inc
Location: Princeton
Posted on: February 25, 2021

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 in our Princeton, NJ office.--

This position--will be responsible--for:

  • Influence and implement company/regional policies and strategic direction in quality systems-- improvements --based on current and emerging regulatory trends
  • Ensures readiness for regulatory inspections
  • Collaborates across the regional organization to lead cGMP and GDP compliance initiatives and continuous improvement.
  • Provide assessments of company sites, internal GMP departments, external partners and quality systems for compliance to regulatory requirements and expectations, standards, industry trends and regulatory commitments as well as company policies and procedures.
  • Supporting the timely FDA filings and product launches-- and system and product improvements.
    Education & Experience:
    • A minimum of a-- Bachelor's--degree is required with a degree in chemistry, microbiology, or science discipline is required
    • An advanced degree in the sciences, business or reg ulatory compliance is preferred;-- minimum of 15 years of experience in a Q A /Regulatory Compliance role within a Pharmaceutical, Combination Product, Medical Device and Diagnostic, and/or OTC Drug industry environment; minimum of-- 5 years of QA management level experience;-- minimum of 5 years working within a GMP environment including manufacturing plant QA experience
    • Interaction with Regulatory Authorities including leading or managing FDA inspections and internal/external cGMP audits; documentation and technical writing skills, in a regulated compliance environment
    • Strong influencing, negotiations, and leading without direct line authority
    • Ability to manage complexity, manage a diverse team, and effectively negotiate/influence upper management is critical
    • Knowledge of Quality Risk Management principles
      107
      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.

      Please read the legal notice for further details. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Dr. Reddy's Laboratories its subsidiaries or affiliates. You have been redirected to a Dr. Reddy's Laboratories, Inc. job page

Keywords: Dr. Reddy's Laboratories, Inc, Trenton , Lead, Quality, Other , Princeton, New Jersey

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