Eliquent Life Sciences
ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients' needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com.
We are seeking a seasoned
QA Inspection Readiness Consultant
to lead and support audit and inspection readiness initiatives within our GxP-regulated operations. The ideal candidate will bring deep expertise in quality systems and regulatory expectations, and will play a critical role in preparing the organization for successful regulatory inspections and third-party audits. This includes planning, coordinating, and executing comprehensive
mock audits
and
audit readiness assessments , identifying compliance gaps, and ensuring organizational preparedness across all relevant functions.
Key Responsibilities:
Lead
inspection and audit readiness
activities across GxP domains (GMP, GCP, GLP, etc.). Plan, design, and execute
mock regulatory inspections
and
internal audits
simulating agency expectations (FDA, EMA, MHRA, etc.). Perform comprehensive
gap assessments
of quality systems, documentation, and processes to identify potential compliance risks. Develop and implement
audit readiness plans , timelines, and cross-functional deliverables. Prepare teams and SMEs for inspection roles through training, coaching, and real-time simulation of interviews and inspection scenarios. Assist in the development of
inspection storyboards , site summaries, organizational charts, and facility overviews. Facilitate the creation and review of
inspection response strategies
and CAPA plans following mock audits or actual inspections. Collaborate with cross-functional stakeholders (QA, Clinical, Regulatory, Manufacturing, PV, etc.) to drive corrective actions and close identified gaps. Support or lead hosting duties during regulatory inspections or audits as needed. Requirements
Bachelor's degree in life sciences, pharmacy, or related field; advanced degree preferred. 8+ years of experience in QA, compliance, or audit readiness in the pharmaceutical/biotech industry. Demonstrated experience leading or supporting regulatory inspections and audit readiness programs. Hands-on experience conducting
mock audits , internal audits, and inspection simulations. Strong understanding of global GxP regulations and ICH guidelines. Proficient in identifying risk areas and developing strategic remediation and training plans. Excellent communication, organizational, and interpersonal skills. Experience with electronic QMS platforms (e.g., Veeva, TrackWise) a plus. Auditor certification (e.g., ASQ Certified Quality Auditor) or formal GxP auditor training. Familiarity with both pre-commercial and commercial stage regulatory expectations. Consulting experience or strong adaptability in project-based environments. Benefits
What We Offer:
Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience. Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment. Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.
Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.
We are seeking a seasoned
QA Inspection Readiness Consultant
to lead and support audit and inspection readiness initiatives within our GxP-regulated operations. The ideal candidate will bring deep expertise in quality systems and regulatory expectations, and will play a critical role in preparing the organization for successful regulatory inspections and third-party audits. This includes planning, coordinating, and executing comprehensive
mock audits
and
audit readiness assessments , identifying compliance gaps, and ensuring organizational preparedness across all relevant functions.
Key Responsibilities:
Lead
inspection and audit readiness
activities across GxP domains (GMP, GCP, GLP, etc.). Plan, design, and execute
mock regulatory inspections
and
internal audits
simulating agency expectations (FDA, EMA, MHRA, etc.). Perform comprehensive
gap assessments
of quality systems, documentation, and processes to identify potential compliance risks. Develop and implement
audit readiness plans , timelines, and cross-functional deliverables. Prepare teams and SMEs for inspection roles through training, coaching, and real-time simulation of interviews and inspection scenarios. Assist in the development of
inspection storyboards , site summaries, organizational charts, and facility overviews. Facilitate the creation and review of
inspection response strategies
and CAPA plans following mock audits or actual inspections. Collaborate with cross-functional stakeholders (QA, Clinical, Regulatory, Manufacturing, PV, etc.) to drive corrective actions and close identified gaps. Support or lead hosting duties during regulatory inspections or audits as needed. Requirements
Bachelor's degree in life sciences, pharmacy, or related field; advanced degree preferred. 8+ years of experience in QA, compliance, or audit readiness in the pharmaceutical/biotech industry. Demonstrated experience leading or supporting regulatory inspections and audit readiness programs. Hands-on experience conducting
mock audits , internal audits, and inspection simulations. Strong understanding of global GxP regulations and ICH guidelines. Proficient in identifying risk areas and developing strategic remediation and training plans. Excellent communication, organizational, and interpersonal skills. Experience with electronic QMS platforms (e.g., Veeva, TrackWise) a plus. Auditor certification (e.g., ASQ Certified Quality Auditor) or formal GxP auditor training. Familiarity with both pre-commercial and commercial stage regulatory expectations. Consulting experience or strong adaptability in project-based environments. Benefits
What We Offer:
Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience. Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment. Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.
Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.