A global pharmaceutical leader is seeking a dynamic and experienced Principal Quality Engineer to oversee the QA management of their Illinois manufacturing plant. As a key member of the Quality team, you will provide leadership in ensuring adherence to regulatory requirements and driving continuous improvement efforts.
Responsibilities:
- Supervise the QA team responsible for batch record review and product release.
- Author, assess, and approve exceptions, change controls, and CAPAs within the quality system.
- Lead investigations for OOS results and customer complaints.
- Drive strategic quality improvement projects and initiatives.
- Facilitate site transitions to align with drug product expectations.
- Lead internal audits as the site's lead auditor.
- Ensure compliance with internal and fundamental cGMP guidelines.
- Identify, assess, and rectify gaps in data integrity.
Requirements:
- Bachelor's degree in Chemistry, Chemical Engineering, or a related discipline. Equivalent combination of education, experience, and competencies will be considered.
- At least 8 years of experience in QA/QC within pharmaceutical manufacturing.
- ASQ CQA credential is preferred.
- Demonstrated track record in personnel and project management.
- Thorough understanding of FDA CFR and ICH guidelines.
- Familiarity with current GxP, GLP, or GMP requirements.
- Proficiency in Six Sigma and/or Lean manufacturing methodologies.
- Expertise in cGMP guidelines and both US and international pharmaceutical manufacturing regulations.
