Quality Assurance Manager - ESO Injectables

Overview

Quality Assurance Manager - ESO Injectables

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. As an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. 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.

Join us as a Quality Assurance Manager (QAM) in newly carved out ESO Injectables organization within STO Large Molecules & Injectables Platform .

Responsibilities

Acts as Single Point of Contact / SPOC for all quality related activities at the External Supplier.

Build and proactively maintain strong strategic relationship with suppliers beyond issues escalation and resolution.

Wherever needed, work with the supplier on a documented remediation plan and ensure systematic transition to ‘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.

Drive supplier performance to improve KQIs through monitoring, evaluating and providing feedback to supplier on performance.

Evaluate, approve investigations for critical Complaints & Deviations, address signals & trends and work with supplier to put appropriate measures in place to minimize recurrence.

Assess the impact of Sandoz audit / HA inspection outcomes at supplier and ensure robust CAPAs and timely closure.

Actively 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 & key stakeholders on topics of importance e.g. those impacting product quality and supply.

Devise and implement action plans for quick resolution of stock out cases. Communicate in timely manner.

Represent ESO QA in Global escalation calls and implement lessons learnt.

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 exceptions 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)

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 but not limited to EU GMP Annex-1, US FDA.

Strong technical understanding of pharmaceutical processes – specifically around sterility assurance aspects.

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 minimally 5 years’ experience in QA.

Experience of managing key quality processes including but not limited to exceptions handling, complaints management, batch records reviews, QAA, QRA, APQR.

Efficient management of internal and external stakeholders.

Ability to work in a matrix organization / set-up.

Ability to drive performance improvement initiatives / transformation.

Open to adapt with new work environment.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is (y)ours to shape!

Commitment to Diversity & Inclusion

Sandoz is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, visit Sandoz.com / careers

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