🌎
This job posting isn't available in all website languages
📁
Natural Sciences Research
💼
Health Solutions
📅
180YB Requisition #
Share this Job

RTI Health Solutions (RTI-HS) is the place you turn to when you need substantiated, authoritative evidence and advice. We are scientists first—academically-trained, credentialed researchers who know how and when to apply the appropriate research methodologies to your real-world applications and situations.

 

 

Located across the US and Europe, our staff have led projects in approximately 70 countries. Our experience is diverse for ‘Outcomes Research’ which encompasses health economics, public health, market access, patient reported outcomes,  epidemiology and risk management, statistics, survey research, clinical trials, and other disciplines; and spans applied research studies for both developed and emerging markets. We can help our clients with an array of projects in many countries and regions of interest.

 

 

Our standards of professional performance are enhanced by having an independent Office of Quality Assurance (OQA). The OQA supports staff on regulations, guidelines, and the implementation of standard operating procedures and quality control processes that result in high-quality processes and deliverables.

 

 

We are currently looking to add a Senior Manager of Quality Assurance to a growing team within the OQA.  In this role, you will collaborate with a team responsible for oversight of the Global Quality Management program at RTI-HS, with staff located in US, Barcelona, Manchester (UK), and Sweden.  Additionally, you work with the leadership team to plan and consult on quality strategy for clients for all RTI-HS projects.

 

 

 

Responsibilities will include but not be limited to:

  • Serve as a regulatory and quality resource for practice areas and project teams.
  • Perform audits and reviews to help assure that the quality and regulatory obligations of the sponsor contract are met in a cost effective and timely manner.
  • Work with the Director of OQA to serve as a back-up and to help manage the RTI-HS Quality Management System and related processes.
  • Work with OQA leadership to provide training, knowledge management, and strategic quality consultation to internal and external customers as needed.  Areas of consultation may include but not be limited to Risk Management, IT security and privacy, GCP, and IRB compliance.
  • Serve as one of our quality points of contact for regulatory inspectors and clients, including hosting audits.
  • Coordinate with validation experts around hosted and on-site validated systems as a QA resource.
  • Perform audits and help manage the qualification of external vendors to ensure compliance with applicable regulations and standards.
  • Perform both internal and external audits domestically and internationally, which includes investigator site visits, outcomes research tools and data sources, process audits, validated system audits, project audits and subcontractor qualifications.
  • Perform proposal reviews for inclusion of Quality Assurance budget and text.

 

 

Qualifications:

  • Bachelors level degree in a scientific or life sciences discipline
  • A minimum of 10+ years of relevant and increasingly responsible experience in the Biotech/Pharmaceutical Industry in a GCP quality role and compliance, clinical monitoring or equivalent.
  • Demonstrated expertise of Good Clinical Practice (GCP).
  • Familiarity with IT System/Software Development Life Cycle (SDLC) and validation needs and activities.
  • Demonstrated audit conduct experience is required, including experience supporting regulatory authority inspections.
  • RAC, CQA or equivalent certification.

Preferred:

  • Preferably Demonstrated familiarity of ‘Outcomes Research’.

#LI-BM1

Physical and mental demands of this role include those that must be met by an employee to successfully perform the essential functions of this job, as outlined above.  Examples include:  remaining in a stationary position for long periods of time; operating a computer and other office machinery; thinking, learning, and concentrating effectively and frequently communicating with other people, both within RTI and outside of RTI; frequently moving about inside and travel between offices and laboratories; frequently conducting laboratory site inspections (if applicable), ability to handle the stress associated in meeting frequent, multiple and tight deadlines, ability to work in excess of 40 hours per week as workload and deadlines may require, consistent demonstration of mental stability and ability to have regular, reliable and predictable attendance.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job, per RTI procedure 4.2.1. 


RTI International is an independent, nonprofit research institute dedicated to improving the human condition. Clients rely on us to answer questions that demand an objective and multidisciplinary approach—one that integrates expertise across the social and laboratory sciences, engineering, and international development. We believe in the promise of science, and we are inspired every day to deliver on that promise for the good of people, communities, and businesses around the world. For more information, visit www.rti.org.
 
For USA Job Postings Only: RTI participates in the US Government E-Verify program. Further information regarding the E-Verify program and laws that are designed to protect you against discrimination relating to your legal right to work in the US can be found at https://www.rti.org/jobs.
 
For San Francisco, CA USA Job Postings Only: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Further information is available here.
 
We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. Further information is available here.

Previous Job Searches

My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Submissions

Track your opportunities.

My Submissions
Please try again.

Oops!

Either there was a problem on our end with the action you just performed, or we are currently having technical difficulties with our system. Please try again later.

Connect

To learn more about our research and consulting services, please call us at:

  • US: +1.800.262.3011
  • Spain: +34.93.241.7766
  • UK: +44(0)161.447.6000
  • Contact us