EPM Scientific
GxP Quality Auditor / Sr Quality Lead
EPM Scientific, Greenville, North Carolina, United States, 27834
Base pay range
$90,000.00/yr - $145,000.00/yr
Direct message the job poster from EPM Scientific
Quality Assurance/Control Recruitment Consultant | Specializing in Life Sciences Talent at EPM Scientific Location:
Greenville, NC Employment Type:
Full-Time, On-Site Salary Range:
$87,780 - $145,307/year
Company Overview A leading life sciences organization is seeking a
GxP Quality Auditor / Senior Quality Lead
to support compliance and quality governance across multiple manufacturing lines. This company partners with global pharmaceutical and biotech firms to deliver solutions that ensure regulatory excellence and operational integrity.
Position Summary The GxP Quality Auditor / Senior Quality Lead will play a critical role in maintaining compliance with global regulatory standards and driving quality initiatives. This position requires expertise in pharmaceutical compliance, bracketing strategies, and regulatory interpretation in a GMP-regulated environment.
Key Responsibilities
Coordinate between site and global teams to align SOPs and bracketing strategy
Provide regulatory and technical interpretation to ensure compliance with FDA, EMA, and HMRA requirements
Develop and defend bracketing justification for multiple manufacturing lines and isolators
Facilitate governance meetings, elevate risks, and report status to leadership
Review and approve protocol templates, summaries, and reports for finalization
Qualifications
Bachelor's degree in a scientific or industry-related field
Minimum 7+ years of experience in pharmaceutical manufacturing or compliance
Proven experience developing bracketing and matrixing strategies
Strong knowledge of FDA, EMA, and HMRA regulations
Familiarity with cGMP and facility/equipment validation requirements
Excellent technical writing and communication skills
Ability to work full-time on-site in Greenville, NC
Why Join This Team?
Competitive compensation and performance-based incentives
Comprehensive benefits package including medical, dental, vision, and retirement plans
Paid time off, holidays, and professional development opportunities
Collaborative culture with strong career growth potential
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at EPM Scientific by 2x
Get notified about new Senior Quality Auditor jobs in
Greenville, NC .
5959 - GxP Quality Auditor / Senior Quality Lead #J-18808-Ljbffr
Direct message the job poster from EPM Scientific
Quality Assurance/Control Recruitment Consultant | Specializing in Life Sciences Talent at EPM Scientific Location:
Greenville, NC Employment Type:
Full-Time, On-Site Salary Range:
$87,780 - $145,307/year
Company Overview A leading life sciences organization is seeking a
GxP Quality Auditor / Senior Quality Lead
to support compliance and quality governance across multiple manufacturing lines. This company partners with global pharmaceutical and biotech firms to deliver solutions that ensure regulatory excellence and operational integrity.
Position Summary The GxP Quality Auditor / Senior Quality Lead will play a critical role in maintaining compliance with global regulatory standards and driving quality initiatives. This position requires expertise in pharmaceutical compliance, bracketing strategies, and regulatory interpretation in a GMP-regulated environment.
Key Responsibilities
Coordinate between site and global teams to align SOPs and bracketing strategy
Provide regulatory and technical interpretation to ensure compliance with FDA, EMA, and HMRA requirements
Develop and defend bracketing justification for multiple manufacturing lines and isolators
Facilitate governance meetings, elevate risks, and report status to leadership
Review and approve protocol templates, summaries, and reports for finalization
Qualifications
Bachelor's degree in a scientific or industry-related field
Minimum 7+ years of experience in pharmaceutical manufacturing or compliance
Proven experience developing bracketing and matrixing strategies
Strong knowledge of FDA, EMA, and HMRA regulations
Familiarity with cGMP and facility/equipment validation requirements
Excellent technical writing and communication skills
Ability to work full-time on-site in Greenville, NC
Why Join This Team?
Competitive compensation and performance-based incentives
Comprehensive benefits package including medical, dental, vision, and retirement plans
Paid time off, holidays, and professional development opportunities
Collaborative culture with strong career growth potential
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at EPM Scientific by 2x
Get notified about new Senior Quality Auditor jobs in
Greenville, NC .
5959 - GxP Quality Auditor / Senior Quality Lead #J-18808-Ljbffr