Global QA Compliance Manager Biosimilars in Holzkirchen bei Sandoz

Job Summary/Purpose

Managing Global Sandoz Quality Assurance Compliance related activities for Sandoz Technical Operations with focus on Biopharmaceutical Manufacturing Facilities. Oversight and ensure that all aspects of the operational business comply with cGxP, legal and regulatory requirements, Sandoz Quality Manual and internal standards. To ensure implementation, follow up and completeness of the Quality Plan, Quality Compliance strategy and Quality reporting. To ensure that a proper escalation and quality incident management process is followed, cGMP-compliant Quality decisions are taken and systematic and sustainable CAPAs are defined and implemented. To ensure adequate Health Authority inspection preparation of all respective sites and continuous improvement and optimization of the quality systems is introduced across the platform.

Your Key Responsibilities:

• Ensure and lead Global Compliance activities within the Sandoz Technical Operations Biosimilars platform, provide strategic guidance to local QA Compliance teams and Quality Heads. Ensure compliance with global standards and policies via active working relationship with Sandoz Global QMS.
• Ensure that sites are implementing GxP compliant processes in line with Quality Manual, Global Standards and applicable Health Authority Regulations
• Ensure that the sites are implementing sustainable & systematic CAPAs for deviations, complaints, quality incidents, recalls and Health Authority as well as internal inspections
• Lead, participate, support global quality/ compliance initiatives and GxP upgrade projects in in the platform in line with business objectives. Ensure improvement of Sandoz compliance practices, introduce best international compliance practice for generic industry in Sandoz Technical Operations Biosimilars and support the permanent Sandoz growth with appropriate compliance level of Sandoz operations
• Provide oversight and governance through effective metrics (KQI, KPIs) in alignment with Global Quality reporting strategy. Monitor and report compliance trends and issues. Ensure effective remediation of significant quality and compliance issues.
• Ensure site readiness for regulatory Health Authority inspections (e.g. US FDA, EU, EAEU, ANVISA)
• Support platform in close collaboration with incident management for escalations, ensure timely and cGMP compliant decisions, define/implement systematic and sustainable CAPAs & ensure follow-up including Health Authority Notifications (e.g. BPDRs, Field alert report) in case of Field actions & recalls
• Governance process: Ensure effective communication process to share lessons learned related to quality compliance risks and best practices

What you’ll bring to the role:

• Degree in Pharmacy, Chemistry, Microbiology or other related science
• Min. 5 - 10 years’ experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration or manufacturing
• Excellent technical understanding and knowledge of international cGMP regulations (US FDA, EU, EAEU)
• Excellent technical knowledge in Biosimilars manufacturing (products, processes & equipment, validation, launches, QC, regulatory)
• Excellent management, interpersonal communication, negotiation and problem solving skills
• Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams
• Fluent written and spoken English

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 ours to shape!

Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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