Description
We are urgently seeking a QA Manager to come in and oversee all CMOs for a small molecule oncology product. This QA Manager will report into the Director of Quality Operations, but possess an extremely high level of responsibility. We are looking for an experienced QA professional who can maintain and establish QA systems, processes, procedures and controls in order to maintain the product quality for the future.Key Responsibilities:
- Quality oversight of contract manufacturing organizations.
- Quality representative for FDA investigations related to product compliance. Includes oversight and evaluation of discrepancies and CAPAs.
- Manages all documents received from CMOs through document change control and archival process, as required by internal procedures.
- Coordinate annual product quality reviews with suppliers and internally as required.
- Initiate updates and creation of new SOPs as required.
Skills Required:
- 5+ years working in Quality Assurance for an FDA regulated Pharmaceutical or Biotech company.
- Highly extensive knowledge of cGMP standards and quality systems.
- Must posses Quality management and leadership skills.
- 20-30% travel required
If you believe that you have the skills and can fulfill these responsibilities, please apply and I will reach out to you shortly.
To find out more about Real please visit www.realstaffing.com