QA Manager, Analytical Services - Combo Products

Role Summary

QA Manager, Analytical Services will oversee quality oversight for QC chemistry and microbiological testing of materials and UTC combination products, ensuring timely and compliant QA practices. This role is part of a greenfield project to stand up a new Quality Assurance team, requiring that you think creatively, troubleshoot, and make fast but accurate decisions. You will provide oversight and guidance on day-to-day activities of scientists in the Combination Products QC laboratory and serve as an internal technical expert for Quality Assurance activities. Location: Durham, NC (on-site).

Responsibilities

• Provide QA management and oversight of QC laboratory operations for all defined QC testing activities including incoming materials, in-process samples, and drug substance and drug product testing, including oversight of assigned product development (R&D) testing and contract laboratory testing
• Develop and lead implementation of the quality assurance procedures and activities to ensure that the company’s processes and products are in compliance
• Oversee departmental training including generation, review, and approval of training plans, delivery of hands-on training as needed, monitoring for departmental training compliance, development of new training requirements as needed, and retraining needs and frequencies
• Lead and support QA continuous improvement initiatives related to compliance/quality requirements, introduction of new products/processes, and QC operations, including evaluating emerging technologies, new instrumentation, and alternate methodologies and recommending implementation, as appropriate
• Conduct or provide management oversight of investigations and deviations related to testing or other QC processes and perform QA approval
• Review and approve SOPs, test methods, and product specifications to ensure alignment with regulatory requirements, internal quality standards, and industry best practices
• Review and approve laboratory instrumentation qualification and validation protocols, test method transfer protocols, and other testing protocols, including testing to support process validations, process or material changes, development product stability, etc.
• Review and approve Certificates of Analysis (CoAs) to ensure accuracy, completeness, and compliance with regulatory standards
• Ensure laboratory metrics are reported in an accurate and timely manner and that those metrics are meeting established performance standards. Actively address any metrics that are indicating performance at an unacceptable level with appropriate departmental managers.
• May direct and manage a team to include responsibility for goal setting, performance evaluations, coaching, mentoring and career development

Qualifications

• Required: Bachelor’s Degree in chemistry or related scientific field
• Required: 8+ years of experience in a GMP pharmaceutical QC laboratory with a Bachelor's Degree or 6+ years of experience in a GMP pharmaceutical QC laboratory with a Master's Degree
• Required: 2+ years of experience providing oversight or technical leadership of laboratory operations in a GMP Quality Assurance setting
• Required: Experience scheduling/prioritizing all assigned QA activities related to commercial manufacturing operations including incoming sampling and testing, in-process testing, finished drug substance or drug product testing, and registration and annual stability programs
• Required: Knowledgeable of FDA cGMP requirements and familiar with USP testing requirements for pharmaceutical and combination products
• Required: Excellent computer application skills required with expertise in Microsoft Suite applications as well as chromatography application programs and LIMS systems
• Required: Hands-on laboratory instrumentation experience and review of HPLC, GC, UV/VIS, and FTIR data
• Required: Experience incorporating project testing activities for remediation activities, new project/product support (development, validation, etc.), implementation/maintenance of laboratory systems such as LIMS, and training QA performance into existing schedules to ensure departments needs are addressed
• Required: Experience and expertise with investigative techniques including OOS methodology, root cause analysis, statistical sampling and shelf life projection tools, etc.
• Required: Technical and leadership experience in GMP, combination products Quality Control laboratory
• Required: Experience reviewing new test methods, test method transfer protocols, and qualification of laboratory equipment protocols (IQ, OQ, PQ)
• Preferred: Master’s Degree in chemistry or related scientific field
• Preferred: Experience resolving problems with contract testing laboratories to meet commercial product timelines
• Preferred: Experience with resource allocation for QA oversight of a commercial QC laboratory

Education

• Bachelor’s Degree in chemistry or related scientific field
• Master’s Degree in chemistry or related scientific field