Manager, Quality and Supply Chain

hace 2 semanas

Buenos Aires, Argentina Akron Bio A tiempo completo

This position will represent Akron Bio, a U.S. based company's, business interests in BsAs, Argentina. This person will report to the Head of Quality at Akron Bio and will support the quality and supply chain functions as the primary point of contact with our manufacturing partners in Argentina. This person will ensure that the goals of Akron Bios are met including right first time and on-time in-full shipments. Additionally, this person will have the opportunity to support new product introductions in the Buenos Aires area. The core focus of the role is with one of our partners, located in BsAs._

Primary Responsibilities
- 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

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