Manager, Global GMP Compliance

United Therapeutics•Rtp, NC

9d•Hybrid

About The Position

The Manager, Global GMP Compliance is responsible for managing Quality Management Systems (QMS) and various compliance activities. This role ensures ongoing compliance with current Good Manufacturing Practices (cGMPs), applicable regulatory requirements, and UTC requirements. As an integral member of the Global GMP QMS and Compliance team, this position supports the maintenance and continuous improvement of Quality Management System and compliance processes to ensure ongoing company and product compliance with FDA and other global regulatory agency requirements. The company, United Therapeutics, is the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation, with a purpose to provide a brighter future for patients through the development of novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. They have six FDA-approved therapies and are working to create manufactured organs to address the shortage of transplantable organs.

Requirements

Bachelor’s Degree in a scientific discipline, life science, or related technical discipline
8+ years of experience in the biotech, pharmaceutical, medical device, biologics, OR related regulated industry with a Bachelor's Degree OR 6+ years of experience in the biotech, pharmaceutical, medical device, biologics, or related regulated industry with a Master's Degree
5+ years of demonstrated experience of Quality Systems principles, practices, and processes such as CAPA, Change Control, Management Review, and Data Analysis in a GMP Quality Assurance role
Demonstrated experience establishing, implementing, and/or managing a regulatory intelligence program within a regulated industry (e.g., pharmaceutical, biotech, medical devices)
Working knowledge of Code of Federal Regulations (CFR) 210, 211, 820, Part 11, and/or other related FDA federal regulations and the ability to analyze regulations and apply them to Quality Systems and processes
Experience with the management review processes requirements
Experience managing product recalls and mock recall activities, including cross-functional coordination and regulatory interaction
Experience monitoring and reporting compliance metrics and KPIs to senior management
Strong analytical, communication, and stakeholder engagement skills to effectively drive compliance initiatives
Foster a culture of collaboration, partnership, teamwork, and continuous improvement

Nice To Haves

Master’s Degree in engineering, chemistry, or other physical science field
3+ years of experience in a Quality Assurance Manager role in a GMP-regulated environment
Knowledgeable or experience in using Quality Management System software applications such as Trackwise Digital, MasterControl, etc.

Responsibilities

Managing and facilitating routine quality data analysis and QMS trending activities
Developing, maintaining, and distributing Key Performance Indicator (KPI) dashboards and metrics for executive and site level management review
Coordinating product recall and market action activities
Monitoring and assessing regulatory intelligence to identify emerging compliance risks, industry trends, and regulatory expectations
Lead implementation, maintenance, and continuous improvement of standardized regulatory intelligence process to identify new or changing regulatory requirement to ensure ongoing awareness
Facilitate cross-functional impact assessment on UTC product and process
Monitor, assess, and interpret regulatory change and emerging compliance trend
Translate insight into actionable recommendation
Proactively communicate regulatory intelligence to relevant stakeholder and support informed, risk-based organizational decision-making
Coordinate product recall process, including planning, execution, documentation, and continuous improvement
Maintain recall readiness through periodic mock recall
Maintain established key quality performance indicator (KPI) and supporting KPI tool (e.g., Power BI) to develop dashboard and communicate periodic metric report to site management and executive leadership
Prepare and deliver training on KPI tool use, report, and dashboard across all site, as needed
Analyze compliance trend and metric, identify risk or gap, and provide clear, data-driven reporting to management
Coordinate corporate level management review activity by compiling, presenting, and interpreting compliance data and effectiveness of quality system control to management
Lead assigned Quality Management System improvement initiative, ensuring process align with UTC expectation and applicable regulatory requirement
Track Quality Plan improvement activity and provide status update and progress report
Support and manage emerging quality program such as Quality Maturity Index and Quality Risk assessment
Monitor and report compliance metric related to Health Authority and/or Notified Body inspection outcome
Manage implementation of UTC-wide compliance initiative, including ISO registration and related activity
Support regulatory inspection, including site inspection readiness activity such as audit record initiation and follow-up activity
Represent Global GMP Compliance during Health Authority inspection