Details
Essential Functions:
Ensure that Quality Systems are designed and operating in a way to provide appropriate support in all GxP areas of the company and are in compliance with current ISO and GMP standards (cGMP) both US FDA and EU.
Develop/Lead Quality Engineers as they continuously improve the manufacturing plant processes and procedures to meet Quality, Compliance and Business objectives.
Trend Monthly Quality data (NCMR, CAPA, etc.) to ensure quality resources are being properly deployed to address the needs of the business.
Drive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability
Education and/or Experience
To perform this job successfully, an individual must be able to execute each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Must have strong working knowledge in:
21CFR820, ISO13485:2016, ISO14971
Process validation (IQ/OQ/PQ/TMV/MSA)
Ideally both in transferring/scaling up existing processes as well as developing new processes
NCMR, CAPA, Change control and GDP experience
At least 10 years experience in Quality Management/Quality Systems/ Audit Program Management