Lead, Quality Audits Management
*US working authorization required
Salary: This role will range from a Manager-AD title depending on the candidate, so the salary range is reflective of that gap.
$125k - $185k base
A Pharmaceutical company focused on treating ALS is looking to add a Lead, Quality Audit Management to their rapidly expanding team!
This newly created position will be a key member of the Quality Leadership Team. The Lead, Quality Audit Management is accountable for supporting the risk-based vendor management program for GxP Quality, and for providing support in presenting the program during regulatory inspections, if required.
- Support development of yearly audit plan per internal procedures and manage using the eQMS system.
- Execute and close out internal and external audits per an approved audit schedule, and write audit related documents (agendas, reports, etc.).
- Document audit observations, evaluate auditee's responses and CAPAs in electronic system and monitor until closure.
- Determine and document decisions on supplier qualification status, escalate critical findings to Senior Management.
- Perform risks assessments for new vendors and maintain and update the approved vendor list.
- Write, revise, and review procedures for the supplier management program and generate KPIs for audit management.
- Participate in regulatory audits, PAI readiness audits, BIMO readiness visits and inspections as directed by QA Management.
- Up to 50% travel, domestic and international.
- BS / MS in a scientific or engineering discipline
- Minimum of 8 years of experience in pharmaceutical / biotech industry within Quality Assurance, executing audits at following vendor types:
- API Manufacturers (small molecules, preferred)
- Oral Dosage Form Drug Product Manufacturers e.g. tableting, capsules, etc.
- Clinical Warehouses and Distribution Centers for clinical and, preferable also for commercial drug products
- Clinical Investigator Sites
- BIMOs (US and EU)
- Packaging and Labeling operations
- Contract Testing Labs
- Working knowledge of:
- Writing and negotiating Quality Agreements
- Regulatory Compliance, Quality System Management and Quality Assurance principles and practices
- QMS electronic platforms
- FDA and EU cGMP requirements as applicable to GxP areas
This REMOTE opportunity will be filled quickly, so don't hesitate. Apply today!