United Therapeutics Corporation · 2 hours ago
Associate Director, QA Engineering - Combo Products
Triangle Area
Full-time
Onsite
Lead/Staff, Director/Executive
10+ years expUnited Therapeutics Corporation is a publicly-traded biotech company focused on developing novel pharmaceutical therapies and technologies for transplantable organs. The Associate Director, QA Engineering will lead a QA team, ensuring compliance with cGMP for combination products and managing quality engineering activities throughout the product development lifecycle.
BiotechnologyPharmaceuticalTherapeutics
Hiring Manager
William Neutzling
Responsibilities
Work independently and as part of a multi-functional team to manage, lead, and prioritize workloads, complex projects/tasks, departmental initiatives, and deadlines
Manage quality engineering input and provide advanced technical expertise to processes and manufacturing documentation, including complex data analysis, material specifications, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested and that compliance to quality systems procedures, regulations, and standards are achieved
Support the trending and reporting of CAPA activities. Lead investigations and serve as an internal expert for Risk Assessments, Quality Events, Investigations, Out of Specifications (OOS), Change Controls, Exceptional Conditions, and Corrective and Preventive Action (CAPA) processes for GxP events
Interact regularly with peers and senior management across multiple functional groups (e.g., Research and Development, Manufacturing, Validation, Regulatory Affairs, etc.). Negotiate and manage expectations across functional groups for project timelines and quality requirements
Lead and manage quality engineering activities and provide SME support for project start-up and the technology transfer of new products or methods into existing manufacturing operations. Responsible for evaluating new technologies against applicable guidance, and industry practices
Provide support during external, internal, and health agency audits
Author, collaborate, analyze, and approve cGxP related documents (i.e., product/ design specifications, computerized systems, validation protocols and reports (IOQ/PQ), analytical/microbiological method validations, stability protocols, operational protocols and reports, Site Master Files, DHF, DMR, etc.) for accuracy, completeness, and compliance with cGMP and UTC policies, procedures, and requirements
Participate in supplier selection process and specification reviews as necessary
Participate in, and/or lead, quality system, process and product-related decisions. Recommend and manage changes to policies and establishes procedures affecting immediate function/group
Collaborate with different members of the QA/RA departments working on special projects
Manage, lead, and support quality system project initiatives and continuous process verification. Through continuous oversight, identify gaps and coordinate resolution, and quality improvement initiatives
Coordinate and lead internal mock audits in preparation of the site readiness for health agency inspections
Mentor peers on technical information on projects, mock audits and recalls, and other areas of expertise
Direct and manage team to include responsibilities for goal setting, performance reviews/management, coaching, mentoring and career development
Qualification
Required
Bachelor's Degree in engineering, chemistry, biology, biochemistry, or related scientific discipline or Master's Degree in engineering, chemistry, biology, biochemistry, or related scientific discipline
12+ years of experience in quality assurance, quality engineering and management in the FDA regulated environment or a related industry with Bachelor's degree or 10+ years of experience in quality assurance, quality engineering and management in the FDA regulated environment or a related industry with Master's degree
5+ years of experience leading multi-discipline engineering projects with previous participation in regulatory inspections
Ability to manage, mentor, and/or provide technical guidance to other engineers/project team members
Clear understanding and application of QA and cGMP principles, concepts, industry practices, and standards
Able to work independently and as part of a multi-functional team, being able to manage and prioritize workloads, stressful situations, and deadlines
Demonstrated expertise with FDA Quality System regulations and cGMP, ISO 13485, ISO 14971, ISO 10993, IEC 60601, IEC 62304, 21 CFR Part 11, 210, 211, and 820
Clear understanding of US FDA, EU, and JP GMP regulations
Knowledge of software validation practices and data integrity initiatives
Familiarity with pharmaceutical operations (i.e., aseptic filling, etc.), solid oral dose, biologics operations, medical devices, and combination products
Strong technical writing skills
Strong experience in regulatory inspections
Strong computer skills and demonstrated competence to include MS Office applications, database applications, and spreadsheet in a network environment
Able to work independently with occasional to no need for guidance
Strong organizational skills and strong attention to detail
Preferred
Strong experience with validation and facility qualification
Experience in process development activities for manufacturing/ assembly operations
Knowledge of Laboratory Information Management System (LIMS), Systems Application and Product (SAP), MasterControl, MiniTab, Trackwise, and Empower software systems
Continuous Process Validation experience
Knowledge of software validation practices and data integrity initiatives
Benefits
Medical / dental / vision / prescription coverage
Employee wellness resources
Savings plans (401k and ESPP)
Paid time off & paid parental leave benefits
Disability benefits
More
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
Company data provided by crunchbase