QA Inspection Readiness

Job Description

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

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Health Care Plan (Medical, Dental & Vision)

Retirement Plan (401k)

Life Insurance (Basic, Voluntary & AD&D)

Full-time