Manager, Global GMP Compliance

About the role

The Manager, Global GMP Compliance plays a crucial role in ensuring the company's products comply with Good Manufacturing Practices (cGMPs) and other regulatory requirements. This position is integral to the Global GMP QMS and Compliance team, focusing on maintaining and improving Quality Management Systems and compliance processes.

Responsibilities

• Manage and facilitate routine quality data analysis and QMS trending activities
• Develop, maintain, and distribute Key Performance Indicator (KPI) dashboards and metrics for executive and site level management review
• Cover coordination of product recall and market action activities
• Maintain recall readiness through periodic mock recall
• Coordinate corporate level management review activity by compiling, presenting, and interpreting compliance data and effectiveness of quality system control to management
• Represent Global GMP Compliance during Health Authority inspection
• Support and manage emerging quality programs such as Quality Maturity Index and Quality Risk assessment
• Manage implementation of UTC-wide compliance initiatives, including ISO registration and related activity
• Support regulatory inspection, including site inspection readiness activity such as audit record initiation and follow-up activity
• Track Quality Plan improvement activity and provide status update and progress report

Requirements

• Bachelor’s Degree in a scientific discipline, life science, or related technical discipline with 8+ years of experience OR Master’s Degree in a scientific discipline, life science, or related technical discipline with 6+ years of experience
• Minimum of 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

Qualifications

• Foster a culture of collaboration, partnership, teamwork, and continuous improvement

Skills

• Strong analytical, communication, and stakeholder engagement skills to effectively drive compliance initiatives

Benefits

• Comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more

Pay

Competitive salary commensurate with experience

Schedule

Full-time, 100% on-site at United Therapeutics’ RTP, North Carolina location