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Director of Quality Microbiology

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Providence, RI
Job Type
Direct Hire
Bachelor of Science
May 17, 2017
Job ID
Director of Quality Microbiology
To build and run a new fully compliant QA department for a cGMP sterile 503B manufacturing facility.
Key responsibilities:
  • Implement and ensure compliance with US Food, Drug &Cosmetic Act, 21 CFR parts 210 and 211 Section 503A and 503B, and all its related elements such as facilities, documentation (SOPs and validation protocols, etc.), training, reports and records
  • Manage 503B facility chemistry and microlab for end product testing and environmental monitoring.
  • Manage QA unit’s responsibility for discrepancy and failure investigations and the development and oversight of appropriate corrective actions and preventive actions. Manage the quality control unit’s periodic review records of compounding operations to evaluate the quality standards for each drug product to determine the need for changes in specifications or control procedures (§ 211.180(e)).
  • Manage the quality assurances responsibility for evaluating written and oral complaints concerning the quality or purity of, or possible adverse reactions to, a drug product. Complaint handling procedures must include a determination as to the need for a full investigation and provisions for review to determine whether the complaint represents an adverse event that must be submitted to FDA (see §§ 211.198 and 310.305,and section 503B (b)(5) of the FD&C Act).
  • Lead quality systems activities such as metrics, safety, logbooks and documentation management, safety programs, risk assessment management, etc.
  • Implement and manage a variety of complex cGMP quality systems in multiple technical areas, including SOPs, forms, checklists, etc.
  • Implement and manage the development of analytical methods and microbiology and batch release protocols.
  • Oversee pharmaceutical formulation testing.
  • Assist in with the technical requirements of supply agreements and other external contracts.
  • Facilitate and develop cross site communication and information sharing to ensure communication and implementation of industry best practices.
  • Oversight, management and strategic planning of the departmental budget, implementation of project with budgets and timelines, and develop weekly/monthly goals and schedules to manage activities and team.
  • Serve as an expert in multiple areas and provide information and training to other employees. Perform duties in accordance with established company procedures and policies
Required Qualifications:
  • 10+ years of progressive experience within a cGMP facility
  • Experience managing FDA and other regulatory audits.
  • Experience building GMP compliant quality systems from the ground up.
  • Experience building and running a robust environmental program for sterile production facility
  • Experience building and running a chemistry and microbiology lab to run daily finished product testing
  • Experience working with chemistry and analytical methods to develop stability indicating methods
  • Bachelor's of Science Degree.
Preferred Master’s Degree, Regulatory Affairs