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