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Job Description

General Summary:

The GDP Operational Quality Manager is an internal technical resource in the application of quality assurance and compliance principles to a wide range of disposition activities. The Manager coordinates or executes activities on multiple projects and takes a role in the design and execution of new projects.

Key Duties and Responsibilities:

• Provide quality oversight and support to operations at the Vertex Annex Drug Product Facility in the following key areas: support of manufacturing operations across all phases (development and commercial), support of analytical laboratory operations, and materials management.
• Oversee commercial and clinical batch disposition process. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
• Approve clinical and commercial lot COAs, generating BSE/TSE statements and product labelling
• Archive batch records and other supporting documents
• Generate and analyze performance metrics and trends, including site metrics for disposition, investigations, CAPA, etc.
• Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and consequential quality issues; provide direction for product disposition decisions including shipment.
• Review and approve Manufacturing documents e.g. MCR, MBR, Recipe, Engineering Parameters etc.
• Affirm raw material release, area clearance and equipment release.
• May assist the QA Engineering group with activities associated with equipment, instrument, utilities, and/or facility qualification activities including change control, and support of site programs.
• Provide QA support of development and commercial change controls, GMP investigations, associated CAPAs and Effectiveness Checks. Lead the investigation/CAPA triage meetings (as necessary) and collaborate with customer groups to ensure quality systems are monitored and established metrics are met.
• Lead compliance walkthroughs of the site and help close any observations.
• Identifies risks, communicates gaps, and recommends optimized processes for GMP process/systems, area/equipment release, material disposition, etc.; execute process improvement initiatives to realize efficiency gains
• Support new product introduction into the Drug Product Facility by reviewing and approving new MBRs and material master files.
• Participate in inspection readiness activities and provide support during regulatory site inspections.
• Provide important compliance guidance to business owners; cultivate productive, collaborative relationships and mutual understanding of business needs

Knowledge and Skills:

• Strong foundation and demonstrated experience in:
• providing QA support and oversight of GMP manufacturing operation including batch release
• drug product development and manufacturing
• cGMPs and associated CMC regulatory considerations in a pharmaceutical environment
• Equipment, facilities and utility system qualifications under cGMP
• Leading event investigations, Root Cause Analysis (RCA), and CAPA
• Applications such as Oracle and TrackWise

Education and Experience:

• B.S in scientific or allied health field
• Typically requires experience or the equivalent combination of education and experience

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