Vice President, Quality Operations – Combination Products

United Therapeutics Corporation•RTP, NC, NC

3d•Onsite

About The Position

The Vice President, Quality Operations - Combination Products will oversee all Quality functions associated with United Therapeutics' Dry Powder Inhalation and Soft Mist Inhaler production facilities. These facilities will manufacture, label and package finished drug product and medical devices. This functional site head role ensures these products meet global GMP/GDP regulations, UT quality standards, will drive compliance and will foster a culture continuous improvement. The VP position will provide strategic leadership in regulatory compliance for these drug products and medical devices, lead Health Authority interactions, and support collaboration to achieve operational excellence.

Requirements

Bachelor’s Degree in scientific discipline with equivalent experience/training
15+ years of experience with progressive increases in responsibility in quality aspects of the pharmaceutical or fine chemicals industry
10+ years of management experience, inclusive of 5+ years overseeing both QA and QC functions
7+ years of experience in FDA, USP and EP testing requirements
5+ years of experience in stability testing programs
Experience in instrumentation and expertise in HPLC, GC, UV/VIS, FTIR
Experience in US FDA, EU, and JP GMP regulations
Experience in analytical method development/validation and lab method transfer protocols
Experience in lab and manufacturing equipment qualification (IQ,OQ, PQ) protocol review, writing and application
Experience in departmental budgeting
Advanced working knowledge of cGMPs
Demonstrates exceptional attention to detail
Exhibits strong organizational skills
Effective in prioritizing tasks for self and a team
Able to work independently and collaboratively within a multi-functional team
Thrives in high-pressure environments, managing heavy workloads and tight deadlines
Possesses advanced proficiency in MS Office applications, with expertise in MS Word and Excel

Nice To Haves

Master’s Degree in scientific discipline with equivalent experience/training

Responsibilities

Oversee Quality Operations, ensuring all aspects of drug product and medical device manufacturing, labeling and packaging comply with GMP/GDP and applicable global regulatory standards
Provide quality leadership in drug product and medical device manufacturing and packaging activities to facilitate timely product disposition
Ensure compliance with FDA and other applicable global regulations for drug products and medical devices
Lead Quality activities related to the facility start-up, including equipment qualification, process validation, and regulatory filings
Manage Health Authority inspections for the facilities, ensuring audit readiness and successful outcomes
Collaborate with Manufacturing teams to establish effective quality standards, ensuring functionality and patient safety
Oversee and approve GMP documentation, including batch records, deviations, validation protocols, and regulatory filings
Build and maintain Quality Agreements with numerous manufacturing vendors and device suppliers supporting the production of drug products
Adapt existing quality systems and procedures to current combination product requirements, including design control, risk management, and post-market surveillance
Evaluate quality systems through routine risk assessments and drive the implementation of corrective and preventive actions (CAPAs) to improve product and process quality
Lead cross-functional teams in technology transfer activities, ensuring seamless integration of drug and device components into a combination product
Drive continuous improvement initiatives to enhance manufacturing processes, product quality, and operational efficiency while maintaining compliance
Collaborate with supply chain teams to ensure the uninterrupted supply of products, meeting the highest quality standards
Represent the Quality function in leadership meetings, communicating goals and progress to internal stakeholders and regulatory agencies
Monitor and integrate emerging regulatory requirements for combination products, ensuring the organization remains compliant and proactive in adapting to changes
Develop and maintain training programs to ensure quality staff are proficient in combination product regulations, quality systems, and manufacturing processes
Partner with Manufacturing, Regulatory Affairs, and Engineering to support manufacturing scale-up and ensure regulatory submissions meet global expectations
All other duties as required