Quality Assurance Manager - ESO Injectables

Sandoz Iberia; España; Híbrido; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company is seeking a Quality Assurance Manager to oversee quality-related activities at external suppliers. The role requires a University Degree in Natural Sciences and over 10 years of experience in the pharmaceutical industry, particularly in sterile and aseptic product manufacturing. Strong communication and risk management skills are essential for managing supplier relationships and ensuring product quality. This position offers a flexible hybrid work environment.

Servicios

Flexible hybrid environment

Opportunities for personal growth

Formación

• 10+ years in the pharmaceutical industry with experience in sterile/aseptic product manufacturing.
• Knowledge of cGMP requirements, EU GMP Annex-1, and US FDA.
• Experience in Quality Operations including QA with a minimum of 5 years in QA.

Responsabilidades

• Act as the Single Point of Contact for all quality-related activities.
• Manage supplier relationships and performance.
• Implement supplier qualification processes to support timely launches.

Conocimientos

Fluent English

Communication skills

Risk management

Internal stakeholder management

Strong technical understanding of pharmaceutical processes

Educación

University Degree in Natural Sciences

Descripción del empleo

Quality Assurance Manager - ESO Injectables

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

• Education: University Degree in Natural Sciences (Chemistry, Pharmacy, Biotechnology, Biology)
• Language skills: English (fluent)
• 10 or more years’ experience in the pharmaceutical industry, with direct experience of working in or with sterile / aseptic products manufacturing / quality.
• Thorough knowledge of cGMP requirements for sterile / aseptic products manufacturing, including EU GMP Annex-1 and US FDA.
• Strong technical understanding of pharmaceutical processes – specifically around sterility assurance.
• Strong understanding of pharmaceutical regulatory requirements for commercial manufacturing.
• Strong understanding of risk assessment and risk management fundamentals.
• Experience in Quality Operations (QA / QC), Production and / or other relevant operational areas, but must have at least 5 years’ experience in QA.
• Experience of managing key quality processes including exceptions handling, complaints management, batch records reviews, QAA, QRA, APQR.
• Strong communication skills and efficient management of internal and external stakeholders.
• Ability to work in a matrix organization and drive performance improvement initiatives.

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