Associate Director, Global PV Product Complaint Management & Oversight

California, US residents .

The job details are as follows:

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near‑term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).

The cure for end‑stage life‑threatening diseases like PAH, PH‑ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end‑stage organ diseases for which transplant is not currently an option.

We are looking for an Associate Director, Global PV Product Complaint Management & Oversight to lead and elevate global Product Complaint Safety governance structure across devices, drugs, combination products, and biologics at a local US and global level at all product life cycles. This position provides direction to the team and vendors with respect to PC Handling/business practices for efficiency, quality, and compliance impacts.

The ideal candidate is a confident, collaborative PV and product complaint leader who can turn complex requirements into practical solutions that protect patients and strengthen compliance. This role ensures that operational aspects of the safety data collected and processed and assessed as product complaints are managed with rigorous global standards in proper documentation, evaluation processes, and decisions to support the overall global safety surveillance program and proper management of benefit/risk of UTC products in accordance with EU MDR requirements, combination reporting requirements (21 CFR 820 and 211), IMDRF requirements, ISO 13485 (quality management systems), ISO 14971 (risk management), IEC 62304 (medical device software), and ISO 10993 (biological evaluation).

• Functions as horizontal enterprise leader who optimizes and oversees the product complaint governance, inspection readiness, and regulatory compliance across the Product Complaint Safety lifecycle by influencing and implementing strategic initiatives address internal and external business and regulatory issues;
  Anticipate potential internal and/or external business challenges or regulatory nuances and recommend solutions
• Design, develop and implement globally harmonized procedures, training materials, and process requirements necessary to support PC handling activities; make operational decisions and provide recommendations related to safety practices/requirements, policies, programs, and compliance activities
• Evaluate and implement business process changes in response to regulatory updates to ensure the effectiveness PC handling process for drugs, combination products, and/or biologics at a local and global level
• Initiate, plan, coordinate updates current process, to ensure coverage with new products and compliance with GVP, IMDRF and other regulatory…