Bristol Myers Squibb QA Manager – Procedural Documents in New Brunswick, New Jersey

Scope of the role

  • Accountable for the development, management, and continuous improvement of policies and directives to ensure a robust, compliant, and efficient Quality System Framework.

  • Ensure compliance to applicable Quality Policies, Directives, SOPs, regulatory guidance documents, and current good manufacturing (cGMP) practices.

Key responsibilities

  • Proactively engage and collaborate in multi-disciplinary teams to establish solutions to identify, assess and incorporate best demonstrated industry practices to assure cGMP compliance with all applicable health authority requirements and guidance documents.

  • Author Policies, Directives, and SOP’s; manage global review, approval and issuance process of global documents.

  • Manage and continuously improve Policies & Directives to promote compliance and operating efficiencies.

  • Maintain a contemporary knowledge of current industry trends, standards and methodologies as it relates to quality systems and management.

  • Maintain a thorough knowledge of appropriate standard operating procedures and applicable regulatory requirements and guidance documents.

  • Perform other quality systems related responsibilities, as assigned.

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

  • Minimum of 9-11 years experience in the pharmaceutical industry, 3-5 years experience in a regulated function.

  • Experience in multiple areas of QA including but not limited to writing Policies, Directives, and/or SOPs, inspections, change control, investigations, etc.

  • In-depth knowledge of GMP regulations

  • Strong interpersonal and organizational skills

  • Strong collaborative and influencing skills

  • Excellent writing and grammar skills

  • Computer literacy: Microsoft Office

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled