United Therapeutics Corporation · 2 hours ago
QA Manager, Analytical Services - Combo Products
Morrisville, NC
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expUnited Therapeutics Corporation is a publicly-traded biotech company focused on developing novel pharmaceutical therapies. The QA Manager, Analytical Services will oversee quality assurance processes for combination products, ensuring compliance and providing guidance on laboratory operations.
BiotechnologyPharmaceuticalTherapeutics
Hiring Manager
William Neutzling
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
Qualification
Required
Bachelor's Degree in chemistry or related scientific field
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
2+ years of experience providing oversight or technical leadership of laboratory operations in a GMP Quality Assurance setting
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
Knowledgeable of FDA cGMP requirements and familiar with USP testing requirements for pharmaceutical and combination products
Excellent computer application skills required with expertise in Microsoft Suite applications as well as chromatography application programs and LIMS systems
Hands-on laboratory instrumentation experience and review of HPLC, GC, UV/VIS, and FTIR data
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
Experience and expertise with investigative techniques including OOS methodology, root cause analysis, statistical sampling and shelf life projection tools, etc
Technical and leadership experience in GMP, combination products Quality Control laboratory
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
Experience resolving problems with contract testing laboratories to meet commercial product timelines
Experience with resource allocation for QA oversight of a commercial QC laboratory
Benefits
Medical / dental / vision / prescription coverage
Employee wellness resources
Savings plans (401k and ESPP)
Paid time off & paid parental leave benefits
Disability benefits
Company
United Therapeutics Corporation
Founded to find a cure for a daughter’s rare disease, United Therapeutics is a biotechnology company transforming care for people with chronic and life-threatening conditions.
1001-5000 employees
H1B Sponsorship
United Therapeutics Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (13)
2023 (8)
2022 (6)
2021 (9)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
unknown1999-06-17IPO
Leadership Team
Hamlet Bonilla Evertsz
Senior Network Engineer
Recent News
2025-12-29
NH Business Review
2025-11-11
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