I am partnering with a clinical stage Biotech based in northern New Jersey who are developing innovative combination products to secure a Quality Assurance Manager on a 6 month contract with a permanent position available upon a successful consultancy period.
Reporting directly to the Senior Quality & Regulatory Director, you will be responsible for the improvement and maintenance of the Quality System, supplier management and both internal & external auditing.
- Internal and External audits and will be the appointed senior internal audit Lead and involved in external audits for assigned processes
- CAPA and Complaints - Facilitate administrative filing and follow up required to initiate, evaluate, and investigate complaint files for closure including any reportability and corrective actions required
- Supplier Management including driving Supplier CAPAs, non-conformance approvals and review and deviations
- Maintenance of documentation including Quality procedures, forms and all other Quality Records (including technical file, Device Master Records and Device History Records)
- Management of eQMS and documentation control, filing and retention
- Batch Records Review
- Qualifications and Training - Maintains training documentation and qualifications for employees and contract workers by administration of training
- Supporting Regulatory Affairs and Pharmacovigilance on required projects
- Proven Quality Management System auditing experience in the Medical Device industry (ideally a certified auditor)
- Combination product experience in a Quality Assurance capacity (preferred)
- Ability to work autonomously
- Willing to travel up to 10%
If the above is in line with you experience and interest, apply now!
Sthree US is acting as an Employment Business in relation to this vacancy.