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Quality Manager – Pharmaceutical
Abbott
Evansville, Indiana

3 months ago

Job Description

Job Title: Quality Manager – Pharmaceutical

Job Summary

We are seeking a Quality Manager with hands-on experience in the pharmaceutical industry to ensure that all products, processes, and systems comply with quality standards and regulatory requirements. The role involves managing QA/QC operations, driving compliance, and leading audits to maintain product excellence and regulatory adherence.

Roles & Responsibilities

  • Develop, implement, and maintain the Quality Management System (QMS) in compliance with cGMP, FDA, WHO, and ISO standards
  • Lead internal and external audits and ensure timely closure of findings
  • Oversee QA/QC operations, including batch release, deviation management, and CAPA (Corrective and Preventive Actions)
  • Ensure proper documentation, SOPs, and change control procedures are followed
  • Monitor regulatory updates and ensure the organization remains compliant
  • Collaborate with manufacturing, production, and R&D teams to drive quality initiatives
  • Train and mentor QA/QC staff on compliance and quality best practices

Mandatory Skills / Requirements

  • Minimum 10 years of experience in pharmaceutical QA/QC operations
  • Strong knowledge of cGMP, SOPs, regulatory guidelines (FDA, WHO, ICH)
  • Experience in leading audits and managing CAPA processes
  • Excellent documentation and process management skills

Preferred Skills

  • Experience with validation processes and quality metrics
  • Knowledge of pharmaceutical manufacturing and lab operations
  • Familiarity with quality software tools (eQMS, LIMS)

Qualifications

  • Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biotechnology, or Life Sciences
  • Proven track record in pharmaceutical quality management

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