Job description
they develop drugs, devices and diagnostics that improve and save human life.
Pearl Pathways supports companies in their development, manufacturing and
marketing of these products. Our mission is to deliver superior services that
effectively enable our clients to accelerate life science product development.
Pearl Pathways’ service offerings include:
Position
Quality Compliance Advisor
Job Description
The Quality Compliance Advisor is responsible for creating, evaluating and remediating
quality system to ensure compliance with federal regulation for devices and
biopharmaceutical products. This role has the day to day responsibility for leading client
projects to support product development, submissions, and post marketing activities. This
individual must be detail oriented and possess good communication skills.
Responsibilities include:
• Evaluation of manufacturing facilities, labs, clinical sites, and contract research providers
and quality units for compliance with current GXP US and global health authority
regulations
- Develop quality assurance systems, SOPs, and plans to ensure companies are compliant
- Execute internal, external vendor and mock audits to evaluate GCP, GLP and GMP for all
- Conduct vendor assessments for quality standards and technical capabilities
- Development of and execution of training modules on Quality Systems
- Reports directly to the Director Quality/Regulatory
Training/Experience Requirements:
• At least 10 years drug OR device quality compliance experience. RAC or ASQ certification
preferred.
- Bachelor’s degree required
Skills
• Strong technical background required
- Track record of leading quality system strategy and execution for either bio-pharma or
- Both drug and device experience a plus.
- Mix of large sponsor company and small startup experience a plus
- Ability to work autonomously
- Exceptional communication skills, both verbal and written
Send inquiries and your resume to recruiting@pearlpathways.com
Send inquiries and your resume to recruiting@pearlpathways.com.
Company Description
Pearl Pathways is a comprehensive life science regulatory, quality compliance, and clinical services
consulting company providing strategic guidance and project-based support for emerging to mid-
size biopharmaceutical, medical device, and diagnostic companies. As the recognized trusted
advisor and preferred partner for enabling innovative and expedited life science product
development, our nimble and flexible team of experts provide custom solutions that help our clients
deliver lifesaving products to market.
Our consultants collaboratively leverage decades of clinical, scientific, industry, FDA and global
regulatory authority experience to help our clients successfully navigate a highly complex
regulatory environment while balancing risk, speed to market, and cost to achieve their business
goals. Pearl Pathways supports all aspects of human research through its full-service central
independent review board, Pearl IRB. Founded in 2010, Pearl Pathways is headquartered in
Indianapolis, IN and is proud to be a certified Women’s Business Enterprise. For more information,
please contact us at info@pearlpathways.com or visit us at www.pearlpathways.com.
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