We are retained by our client, an innovative and rapidly growing biopharmaceutical company in Ireland’s Mid-West, to recruit a Director of QA Microbiology.
Candidates require microbiology expertise as it relates to drug substance and drug product manufacturing to set the strategy for improvement of practices and procedures in microbial control and compliance. Responsibilities include:
- Working with QC, Manufacturing, Facility Maintenance and Engineering to consistently improve the general facility contamination control program and support remediation efforts where necessary.
- Supporting investigations pertaining to microbial contamination to assure effective root-cause analysis, corrective action plan determination and remediation plans.
- Providing input on technology transfer plans related to microbiological method transfers (method validation).
- Supporting inspection preparations and regulatory inspections.
- Providing input on the development and modification of microbial action limits and microbiology SOPs, microbiology assay validation and related documentation.
- Providing strategic support to understanding and managing excursion trend levels.
- Focusing on team coaching, mentoring and continuous improvement activities.
- Domestic and foreign travel required.
We require candidates with a Bachelor, Master, or Doctorate degree in microbiology, medical technology, biology or related field coupled with significant knowledge and experience in qualifying clean rooms, clean utilities and manufacturing processes. Experience should also include quality control microbiology, quality assurance and regulatory inspections for Biological pharmaceuticals.
This is an excellent opportunity at an exciting time to contribute to the continued success of this dynamic, well established and expanding company. A competitive salary and benefits package will be offered to the successful candidate.