Director of Quality

A large pharmaceutical company is looking for a Director of Quality in Suffolk County. This role is responsible to direct and oversee chemical, physical, and microbiological testing and auditing of raw materials, in-process, finished products, and stability samples in QC laboratories in compliance with all SOPs, test procedures, and cGMP.

Requirements

• Direct laboratory related investigations to ensure all investigations proceed in a logical, orderly, and timely manner.
• Prepare appropriate protocols and ensure execution of such protocols in a timely manner and in compliance with appropriate SOPs.
• Liaise with AR & D group for transfer of in-house developed and validated methods for finished products and APIs.
• Maintain knowledge of the potential impact of Quality Control activities on activities in other departments and effectively communicate this information to the appropriate personnel in a timely manner.
• Provide input to laboratory employees to interpret SOPs and test methods where instructions may not be clear.
• Review COAs to ensure compliance with all specifications and approve for laboratory release.
• Implement solutions where deficiencies are found. Provide formal and informal performance feedback to direct and indirect reports including disciplinary action when necessary.
• Provide input on monthly departmental headcount and turnover of tested samples.
• Develop and implement systems to improve laboratory GMP compliance and/or productivity.
• Review and signoff process validation/cleaning validation protocols/reports, method verification/validation reports, annual product review reports, and method transfer reports.