GxP Quality Auditor / Senior Quality Lead
ilb Consulting ServicesGreenville, NC, United States1 day ago
Job type
- Full-time
Job descriptionLead coordination between site and global teams to align SOPs and bracketing strategy Provide regulatory and technical interpretation to ensure compliance with FDA, EMA, and HMRA Develop and defend bracketing justification for 4 traditional lines, 1 RABS, and 9 isolators Facilitate governance meetings, escalate risks, and provide status to site / global leadership Review and approve protocol templates, summaries, and reports for finalization Bachelor's Degree in an industry-related field Minimum 7+ years industry experience Demonstrated experience developing pharmaceutical bracketing and matrixing strategies Demonstrated experience maintaining FDA, EMA, and HMRA compliance Experience in a pharmaceutical / FDA-regulated manufacturing environment Working knowledge of cGMP and facility / equipment validation requirements Ability to write clearly, concisely, and persuasively in a professional environment Demonstrated ability to interact effectively with all levels of the organization Ability to work as part of a cross-functional team Strong problem-solving, critical thinking skills, and attention to detail
003V5959 GxP Quality Auditor / Senior Quality Lead
Please contact Amanda Mazza, [email protected]
- FTE or Contractor
JOB RESPONSIBILITIES
REQUIREMENTS
LOCATION
On-site 5 days / week, Greenville, NC
EMPLOYMENT
Full-time or Contractor
Create a job alert for this search
Quality Lead • Greenville, NC, United States