United Therapeutics Corporation · 9 hours ago
Senior Director, Quality Operations - Solid Dose
Triangle Area
Full-time
Onsite
Director/Executive
15+ years expUnited Therapeutics Corporation is a publicly-traded biotech company focused on developing novel pharmaceutical therapies. The Senior Director of Quality Operations for Solid Dose will lead site quality operations, ensuring compliance with GMP requirements and driving lifecycle process quality in Manufacturing, Packaging, and Distribution.
BiotechnologyPharmaceuticalTherapeutics
Hiring Manager
William Neutzling
Responsibilities
Oversee, lead and drive the site Quality Operations function; represent function & responsible for strategic planning, direction, and achieving and communicating accountabilities and objectives to internal leadership
Build and maintain strong relationships with internal stakeholders and leaders across the organization
Drive the cooperative and collaborative working relationship with manufacturing site and CMOs and ensure established current and comprehensive Quality Agreements are in place and enforced
Ensure that the facility operations are in compliance with regulatory procedures and guidelines; accountable for the review and approval of all batch records, deviations and change control, validation and certification activities
Oversee and assist in the review and approvals of product packaging and labeling
Host Health Authority inspections and ensure overall audit readiness
Lead technology transfer projects; initiate special projects and support planning and execution
Work with Quality System group to complete risk management assessments; set future direction to improve product/process quality and work with other site quality leadership to maintain robust quality systems across the organization
Effectively create and promote continuous improvement efforts and support initiatives that improve United Therapeutics global quality
Charged with overall responsibility for planning, staffing, budgeting and managing expense priorities
Direct and manage direct reports to include responsibilities for training, goal setting & achievement, performance evaluations/management, coaching, mentoring, career development and provide support for recruitment process (as needed)
Qualification
Required
15+ years of experience with progressive increases in responsibility in quality aspects of the pharmaceutical industry with a Bachelor's Degree or 13+ years of experience with progressive increases in responsibility in quality aspects of the pharmaceutical industry with a Master's Degree
10+ years of people management experience
10+ years of advanced working knowledge and experience with cGMPs and US FDA, EU and JP requirements
5+ years of experience in management over both QA and QC functions; years of experience in small molecule drug analysis, sterile manufacturing or solid dose
5+ years of experience in departmental budgeting
Advanced working knowledge of MS Office applications, including expertise with MS Word and Excel
Knowledge and experience in lab and manufacturing equipment qualification (IQ,OQ, PQ) protocol review, writing and application
Knowledge and experience in stability testing programs
Knowledge and experience in instrumentation experience and expertise in HPLC, GC, UV/VIS, FTIR
Knowledge and experience in FDA, USP and EP testing requirements
Detail oriented, self motivated, organized and have the ability to prioritize work
Must be able to work independently and as part of a multi-functional team, able to handle high workloads, stressful situations and deadlines
Preferred
Master's Degree in scientific discipline with equivalent experience/training
10+ years of experience in analytical method development/validation and lab method transfer protocols
Working knowledge of TrackWise, MasterControl, SAP, Veeva
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
Company data provided by crunchbase