Manager, Quality and Supply Chain (Onsite in Bsas (Buenos Aires)
Akron Bio
- Buenos Aires
- Permanente
- Tiempo completo
- Collaborate with the LPC site teams at Carhue and Saladillo to enable Akron goals to be met
- Act as the quality manager for any complaints, deviations, or concerns and provide on-site support
- Ensure compliance the Quality Agreement and Master Supply Agreement, and any other relevant contracts
- Review relevant documentation to support the release and shipments of products
- Act as point of contact for all audits by Akron and our clients/ customers at sites in Buenos Aires
- Identify, manage and communicate risks
- Ensure the production and shipping plans align with Akron business plans
- Discover, prioritize and implement opportunities for improvement
- Align and support the new product introductions and change controls
- Represents Quality Assurance on cross-functional teams participating in various operational programs such as FMEA development, Risk Management activities, LEAN improvements, and other continuous improvement activities**Qualifications**:- Minimum of 5 years working in the biopharmaceutical, cellular therapy, or gene therapy industries
- Degree in science or related field is preferred
- **Fluent in English and Spanish; excellent verbal and written communication skills are required**
- Quality Assurance management experience
- Working knowledge of standards quality control assays and analytical methods
- Knowledge of ANMAT, FDA, EMA, GMP, ISO regulations and standards.
- Understanding of supply chain fundamentals
- Direct experience supporting the manufacturing, testing, disposition, and distribution of cGMP sterile products in the Manufacturing or Quality organizations.
- Demonstrated capability with trouble shooting, and problem-solving
- Must be highly motivated and able to work independently and also collaboratively with cross functional groups and across companies
- Strong experience with sterility assurance
Kit Empleo