Senior Manager, Clinical Quality Assurance Specialist

3 weeks ago

Silver Spring, Maryland, United States United Therapeutics Full time

Job Summary

We are seeking a highly skilled Senior Manager, Clinical Quality Assurance to join our team at United Therapeutics. This role will be responsible for managing and executing clinical quality oversight activities in support of our active clinical trials, ensuring compliance with federal and international GCP regulations, as well as internal policies and procedures.

Key Responsibilities

  • Develop and implement Clinical Quality Assurance (CQA) Standard Operating Procedures and policies
  • Coordinate the company SOP development and maintenance process to ensure compliance with federal and international regulations
  • Ensure continuous improvement and management of the organization's audit program, to ensure vendors utilized for the execution and management of clinical trials are compliant and approved for the services provided
  • Manage regulatory agency and other audits/inspections of Unither Bioengineering and prepare investigator sites for FDA or other regulatory agency inspections
  • Actively collaborate with other functional areas and investigator sites to prepare viable audit responses and evaluate the adequacy of corrective actions
  • Consult, review and approve study-specific training curriculums to ensure training compliance for the management and conduct of clinical studies
  • Serve as in-house consultant for understanding project-specific requirements regarding federal and international regulations (e.g., privacy, data protection, ethics) to facilitate GCP compliance throughout the lifecycle of a trial
  • Conduct pre- and post-study document reviews and take corrective action
  • Monitor compliance with all regulatory requirements for the protection of human subjects
  • Establish and maintain clinical quality database of observations for quality analysis and assessment and identifies compliance risks
  • Train and mentor junior CQA staff
  • Often interact with the QMS Specialists to support the review and approval of training curriculums, documents, deviation investigations, CAPAs, and effectiveness checks
  • Provide the QA department QMS data to generate departmental metrics for trending and routine Quality Management Reviews
  • Serve as the clinical quality advisor for all studies managed and/or conducted by Uniter Bioengineering
  • Develop and review Quality Technical Agreements with critical vendors
  • Generate study-specific Clinical Quality Oversight Plans and execute accordingly
  • Perform all other duties as assigned

Requirements

  • Bachelor's Degree in a scientific or related discipline
  • 10+ years of direct biotech/pharmaceutical industry experience
  • 5+ years of experience within GCP Quality
  • GCP experience
  • Experience performing CQA functions in/or at both CRO as well as Sponsor companies
  • Experience with process and documentation audits; experience developing process documentation; ability to understand and interpret national, regional, and local regulations
  • MS Office suite of programs, advanced knowledge of MS Word and Excel
  • Strong interpersonal and written/oral communication skills to facilitate interaction with internal and external customers
  • The ability to work effectively and diplomatically with supervisors, peers and support personnel both internal and external to the organization
  • Very strong time management and organizational skills
  • Ability to perform and multi-task in a fast paced and demanding environment
  • Attention to detail and accuracy in work
  • Adaptability to successfully respond to changing priorities and circumstances
  • Ability to work independently with occasional oversight
  • Strong ability to identify gaps and implement creative ideas for continuous improvement
  • Experience with electronic quality management systems such as Trackwise
  • Experience with electronic publishing tools and electronic document management systems
  • Travel up to 25% to conduct site and vendor compliance audits and attend meetings

Preferred Qualifications

  • 2+ years in a clinical process or operations role
  • Certified Quality Manager (CQM)-ASQ RQAP-GCP and/or ASQ-CQA
  • Experience providing support with trials crossing into International regulation requirements for the purposes of GCP compliance and EMA expectations
  • Good Laboratory Practice (GLP) experience

What We Offer

United Therapeutics offers a 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.

At United Therapeutics, you'll realize quickly that it is not an ordinary place to work. When you join our company, you will learn, grow, contribute, have fun, and be challenged. all while making a difference in the lives of our patients.

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