Quality Assurance Manager

Job Description

Located at our large molecule headquarters in RTP, North Carolina, the Quality Assurance Manager position will join the Quality Assurance team in supporting quality operations and in the management of key quality processes for Large Molecule & Advanced Therapy Medicinal Products (ATMP) testing services in a Good Manufacturing Practices (GMP) laboratory environment.

Critical Performance Areas

• Ensure work is executed in compliance with GMP regulatory requirements and SOPs
• Interpret information with a focus on quality using scientifically sound, risk-based approaches
• Work across multiple quality processes within the QMS to support daily operations and ensure delivery of reliable data to clients
• Provide timely and effective communication to impacted stakeholders across different functional areas
• Contribute to continuous improvement of quality and business processes and represent a culture of quality at the site

Essential Job Functions

• Reviews and approves documents, ensuring documentation supporting site quality processes is clear, compliant, and adequate for use in a GMP testing environment
• Edit and approve planned changes, complaints, deviations, non-conformities, OOS investigations.
• Ensure effective root cause analysis and impact assessment has been conducted for investigations, collaborate with stakeholders on suitable corrective and preventive actions, and ensure that conclusions are supported with adequate information and a clear rationale
• Own and coordinate or act in approver capacity for complex change controls, ensuring adequate assessment has been conducted and comprehensive action plans have been identified and implemented prior to record closure
• Develop and support GMP training program for peers and stakeholder teams
• Monitor and report on metrics and KPIs; collaborate with stakeholders to improve quality process efficiency and effectiveness
• Facilitate the coordination of, preparation for, and remediation actions/responses to internal and external audits and inspections
• Monitor compliance signals from internal quality processes as well as regulations and guidelines to ensure alignment of internal documents and processes (ISO 9001, CFR, Eudralex, ICH, various compendia

Requirements

• B.A/B.S. in Life Sciences with 7+ years relevant experience in a quality-facing role (or equivalent combination of education and experience)
• Experience working in GMP testing environment
• Experience in reviewing and approving quality events (i.e., deviations, laboratory non-conformities, OOS/OOT/OOE investigations, CAPAs, change controls) per applicable operating procedures, including complex technical investigations
• Experience supporting internal or external audits and health authority inspection

Other Desired Skills/Abilities

• Prior direct or indirect leadership experience
• Working with QMS (e.g., MasterControl) and LIMS (e.g., Labware) IT systems
• Established subject matter expertise in one of the following areas of the QMS: controlled document management, GMP training program management, data integrity program management, audit/inspection management
• Excellent organizational skills and ability to work and make sound quality decisions independently and quickly
• Strong written and verbal communication skills

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