Job Details
Our client's Quality Assurance group is actively searching for a driven individual to join their expanding team as a QA Supervisor within the QA Compliance Group. This role focuses on ensuring adherence to regulatory requirements, company policies, and procedures. The chosen candidate will aid in regulatory filings, engage in regulatory/client audits, and supervise aspects such as supplier quality, document management, Change Management, and overall Quality Management Systems. Additionally, they will undergo cross-training in various areas of Quality Assurance.
Responsibility:
- Ensuring that the QMS system aligns with regulatory standards.
- Leveraging electronic quality management systems to enhance compliance tracking, trend analysis, and issue resolution.
- Executing both internal and external audit initiatives.
- Overseeing regulatory audits, encompassing FDA, EMA, and other pertinent health agencies.
- Supervising Change Controls, Document Control Quality Metrics, and supplier quality.
- Providing support for quarterly management review (QMR) processes.
- Establishing, executing, and overseeing an inspection readiness program.
- Advocating for the Quality Risk Management program.
- Managing Quality Metrics to ensure adherence to standards.
- Conducting cross-training with the Supervisor of QA Operations and Supervisor of Investigations and CAPAs.
- Reviewing and sanctioning change controls and other GMP documents as appropriate.
- Directing the Suppliers and Vendors Audit Program.
Requirements:
- A bachelor s, master s, or Ph.D. degree in biology, biochemistry, biotechnology, chemistry, or a related field is essential.
- Minimum of five years of experience in cGMP concerning biological products and cell cultures.
- Comprehensive expertise in the field coupled with proven leadership abilities.
- Previous experience in a supervisory role is mandatory.
If this opportunity is of interest please reach out to me on ...@hartmannyoung.com