Quality Assurance Manager - ESO Injectables

Quality Assurance Manager - ESO Injectables

Join to apply for the Quality Assurance Manager - ESO Injectables role at Sandoz Iberia

Overview

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Responsibilities

• Acts as Single Point of Contact (SPOC) for all quality related activities at the External Supplier.
• Supplier relationship management
• Build and proactively maintain strong strategic relationships with suppliers beyond issue escalation and resolution.
• Wherever needed, work with the supplier on a documented remediation plan and ensure a systematic transition to a “Trust” status.
• Facilitate open communication, cooperation, and rapid issue resolution including managing non-performance with supplier.
• Identify and manage any supplier-related risks and resolve conflicts / issues.
• Supplier performance management
• Drive supplier performance to improve key quality indicators through monitoring, evaluating and providing feedback to supplier on performance.
• Evaluate and approve investigations for critical complaints and deviations, address signals and trends, and work with supplier to implement measures to minimize recurrence.
• Assess impact of Sandoz audit / HA inspection outcomes at supplier and ensure robust CAPAs and timely closure.
• Support to resolve quality issues / conflicts with supplier to ensure timely launches.
• Identify and collaborate to eliminate non-value-added tasks in interfacing QA activities with supplier.
• Internal stakeholder management
• Provide visibility and regular updates to leadership and key stakeholders on topics impacting product quality and supply.
• Devise and implement action plans for quick resolution of stock-out cases; communicate in a timely manner.
• Represent ESO QA in global escalation calls and implement lessons learned.
• ESO QA routine tasks
• Implement Supplier Qualification process to support timely launches. Support timely tech transfers as per plan.
• Draft, negotiate, update Quality agreements, PSA / SSA with Suppliers.
• Initiate audit requests and perform timely closure of Audit CAPAs.
• Perform risk assessment during exception management as needed by HA.
• Initiate / evaluate / close change controls, as applicable.
• Approve CQRA and APQRs.

What You Need To Bring To The Role

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz is a leader in this sector with a focus on shaping the future through investments in new capabilities and partnerships, to help more patients access low-cost, high-quality medicines, sustainably.

Our culture is open and collaborative, offering an agile and flexible-hybrid environment with opportunities for personal growth and diversity.

Contact and Additional Information

For more about Sandoz and career opportunities, visit Sandoz.com / careers

#J-18808-Ljbffr