Sr. Auditor

Global Placement Firm•Paramus, NJ

2d•Onsite

About The Position

We are seeking a Senior Quality Assurance Auditor with strong experience in the pharmaceutical or radiopharmaceutical sector. This role is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with GMP, GDP , and other global regulatory standards. The successful candidate will play a critical role in upholding our Pharmaceutical Quality System (PQS) and ensuring inspection readiness across operations.

Requirements

Bachelors degree in Life Sciences, Pharmacy , or a closely related field
5+ years of pharmaceutical QA experience (with at least 2 years conducting audits)
Proven understanding of GMP , GDP , and radiopharmaceutical (RPT) compliance
Familiarity with global regulations including FDA, EMA, ICH
Excellent documentation, communication, and analytical skills
Ability to travel up to 10% for audits (domestic and potentially international)

Nice To Haves

ASQ Certified Quality Auditor (CQA)
ISO 9001 Lead Auditor Certification
GCP/GMP Auditing Certifications

Responsibilities

Conduct internal audits , supplier audits , and contract manufacturer (CMO) audits including routine, for-cause, and risk-based.
Develop and manage audit plans, schedules, and checklists based on regulatory guidelines and internal SOPs.
Assess compliance with FDA, EMA, ICH, and international GMP/GDP regulations .
Review and evaluate deviations, CAPAs, and change control records.
Generate detailed audit reports and communicate findings to internal and external stakeholders.
Track CAPA implementation and verify effectiveness through follow-up assessments.
Support regulatory authority inspections and third-party audits.
Provide expertise on quality and compliance-related matters, promoting audit readiness culture.
Identify systemic gaps, recommend improvements, and drive continuous quality improvement initiatives.
Stay current on regulatory changes, industry trends, and quality system best practices.