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Manager, Global GMP Compliance

United Therapeutics

Research Triangle Park, NC

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JOB DETAILS
SKILLS
Analysis Skills, Biology, Biotech and Pharmaceutical, Cancer, Change Control, Chemistry, Code of Federal Regulations, Communication Skills, Continuous Improvement, Corporate Compliance, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Analysis, Disease, Documentation, Drug Development, FDA (Food and Drug Administration), FDA Requirements, Federal Laws and Regulations, Functional Analysis, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Industry/Trade Analysis, Intelligence Analysis, Interpret Regulations, Leadership, Maintain Compliance, Medical Equipment, Metrics, Monitor Regulations, Organ Transplant, Pediatrics, Performance Metrics, Physical Science, Power BI, Process Management, Product Management, Progress Reports, Pulmonary Disease, Quality Assurance, Quality Control, Quality Management, Realtime Transport Protocol, Regulations, Regulatory Requirements, Reporting Dashboards, Risk, Risk Analysis, Systems Administration/Management, Team Player, Training/Teaching, Trend Analysis, Work From Home
LOCATION
Research Triangle Park, NC
POSTED
9 days ago
California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) . **The job details are as follows:** Who We Are 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. Who You Are 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. Key responsibilities include 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; and monitoring and assessing regulatory intelligence to identify emerging compliance risks, industry trends, and regulatory expectations. 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. + 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. Minimum 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 Preferred Requirements + 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. Job Location United Therapeutics requires this candidate to be on-site at our RTP, North Carolina location 100% of the time (this role does have flexibility for one day working from home a week). At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Eligible employees may participate in the Company’s 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. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities. _We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._ _We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._

About the Company

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United Therapeutics