QA Associate Director - Analytical Laboratory Lead

Posted On Aug 09, 2019 Location ,New Jersey
Experience 3 yrs- 5 yrs Duration FULLTIME

Description

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary:

• Lead team in providing Quality oversight for testing of clinical supplies (investigational products) to assure quality and compliance with Good Manufacturing Practices (GMP) and other applicable regulations and internal procedures.

• Coordinates the assignment of tasks to be performed by the assigned managers/Associates/Specialists.

• Assure the quality of manufactured products complies with all applicable regulations and guidelines.

Responsibilities:

  • Direct and oversee site analytical testing - quality control compliance to regulations and internal procedures.
  • Develop and manage responsibilities for the quality oversight of Analytical Laboratory Control QC/QA including but not limited to the following: change controls, quality agreements, method development, investigations, clinical testing specifications, and raw material release activities.
  • Build and foster strong relationships and partnerships with stakeholders and support groups to meet the demands of a changing business culture and environment.
  • Participate in development of quality policies, global SOPs, and implementation of site SOPs to ensure site compliance with appropriate procedures.
  • Brings to the attention of the Quality Operations Management, any information relating to the impact of legislation on the functions of the department, system deviations, etc.
  • Provides instruction and guidance on quality issues and serves as a resource for the site.
  • Supports site operations during regulatory agency and third party inspections.


Professional experience and qualifications:
  • Knowledge of science generally attained through studies resulting in B.S. or M.S. in chemistry, pharmacy or biology or a related pharmaceutical science
  • A Ph.D. in a related science with 8-10 years of relevant experience within the pharmaceutical or healthcare industry, or a M.S. with 11-13 years experience, or a B.S. with 13-15 years experience; including 5+ years experience in a regulated function.
  • Knowledge of biopharmaceutical analytical methods.
  • Technical expertise in resolution of deviations and development of effective CAPA.
  • Experience in Quality Management at development and/or commercial stage of pharmaceutical operations.
  • Experience within a QA/QC environment is required
  • Broad experience in the manufacturing of sterile and non-sterile products
  • In-depth knowledge of GMP regulations
  • Strong problem solving, interpersonal and organizational skills
  • Strong collaborative and influencing skills
  • Effective written and verbal communication
  • Computer literacy: Microsoft Office and SAP environment Trackwise®, PDLIMs, and other systems as required


Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

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