Lead Quality Compliance Auditor

3 weeks ago


Massachusetts, United States Lifelancer Full time
Job Overview

We are seeking a highly skilled Lead Quality Compliance Auditor to join our team. This role is responsible for developing and implementing a strategic audit plan, aligned with organizational goals and risk profiles, and monitoring compliance across all company organizations.

About the Job

This is a leadership role that requires strategic vision, strong analytical skills, and a deep commitment to quality. The ideal candidate will have a proven track record in designing, building, and implementing a robust pharma-focused audit program.

Key Responsibilities:
  • Develop and implement a strategic audit plan, aligned with organizational goals and risk profiles
  • Monitor compliance across all company organizations
  • Lead, mentor, and develop a high-performing quality audit team
  • Provide strategic direction on quality compliance initiatives, industry best practices, and continuous improvement
Requirements

To be successful in this role, you will need to have a minimum of 20 years of professional working experience in the pharmaceutical industry, including manufacturing, quality control, quality assurance, CMC, regulatory or related compliance experience. You should also have at least 10 years of aggregate experience in a role dedicated to performing audits for GMP, ISO, or ICH, and at least 10 years of hosting FDA, EMA, MHRA, AIFA, ANVISA, and/or other regulatory health authority inspections.

Preferred Qualifications:
  • Expertise in quality compliance auditing
  • Proven track record in designing, building, and implementing a pharma audit program
  • Experience with elements of data integrity covering all areas in a pharmaceutical manufacturing environment
  • Skilled in quality investigations, root cause analysis, audit reporting, and benchmark sharing
What We Offer

We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Lifelancer (https://lifelancer.com) is a talent-hiring platform in Life Sciences, Pharma, and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, and IT domains. For more details and to find similar roles, please check out the below Lifelancer link: https://lifelancer.com/jobs/view/5222bdd937ca9931c351285106a568af



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