Senior Manager, GPS Quality, Training & Compliance

NCBiotech; Durham (NC); Hybrid; USD 90,000 - 120,000; Full time

Job summary

A leading biotech company in Durham, NC is seeking a Global Patient Safety professional with extensive experience in pharmacovigilance. The role involves ensuring quality and compliance in GPS operations, leading training initiatives, and supporting audits. The ideal candidate will have a strong background in life sciences and a passion for improving patient outcomes. This hybrid position requires three days in the office, with relocation assistance available.

Benefits

Medical coverage

Dental coverage

Vision coverage

Paid time off

Paid parental leave

Qualifications

• 10+ years of experience in pharmacovigilance or 8+ years with a Master's degree.
• 5+ years of experience in managing Quality Management Systems.

Responsibilities

• Enhance and maintain quality, training, and compliance of GPS operations.
• Lead and advise on QTC PV matters relating to trials and products.

Skills

Quality Management

Compliance

Pharmacovigilance

Education

Bachelor's degree in life sciences

Master's degree in a medical/scientific field

PhD/PharmD/MD

Job description

California, US residents click here.

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

You have a background in nursing or pharmacy and you're passionate about pharmacovigilance. You are a team player who loves quality, compliance, finding solutions and ensuring training standards are implemented and successful.

This role in Global Patient Safety (GPS) will focus on enhancing and maintaining quality, training, and compliance (QTC) of GPS operations and practices. They will serve as a Subject Matter Expert for pharmacovigilance (PV), quality practices, education/training, and audits/inspections to support both commercial and development products. The QTC role will lead and advise on QTC PV matters relating to trials for advanced regenerative therapies, development and commercial products, driving GPS Operational Excellence. They will lead and advise during PV audit and inspections, enhancing compliance, with UT key stakeholders and partners. They will also support educational initiatives and training curricula for all GPS staff, vendors, contractors & other UT employees supporting PV activities.

Minimum Requirements

• Education and Experience requirements:
  • Bachelor's degree in life sciences industry or related field, and 10+ years of experience in pharmacovigilance in the pharmaceutical industry, or
  • Master's degree in a medical/scientific, or related field, and 8+ years of experience in pharmacovigilance in the pharmaceutical industry, or
• 5+ years of working knowledge of Global and Local PV regulation, Quality Management principles
• 5+ years of experience in managing Quality Management Systems/Records in PV in the pharmaceutical industry
• 5+ years of management of pre, peri, and post pharmacovigilance audits and inspections
• 5+ years of experience in oversight or establishing training in Pharmacovigilance related areas including PV Operations, Safety and Medical Science, Affiliate, Alliance and Contracts Management, and PV Systems

Preferred Qualifications

• PhD/PharmD/MD
• RN - Registered Nurse - State Licensure and/or Compact State Licensure, or
• Pharm-D - Registered Pharmacist, or
• RPH - Registered Pharmacist

Job Location & Travel

Relocation assistance available. This hybrid role is located in the Durham, NC office and currently requires three days per week in the office. The team will be open to considering candidates for the Silver Spring location, but preference is the Durham, NC office location. In office requirements could increase based on business needs.

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.