RA Associate Director Regulatory Compliance (d/f/m)
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. By creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us, the future is ours to shape!
This position is a strategic role for Sandoz Regulatory Affairs to drive compliance topics, process and efficiency topics, audits, inspections and risk management tasks under one umbrella of Regulatory Operational Excellence within Sandoz Regulatory Affairs. It includes the audit/inspection management in Regulatory Affairs, as well as compliance topics, including the quality management oversight with the corresponding quality key indicators such as metrics, deviations, escalations, trainings, etc. Keeping the strategic oversight, negotiation and influencing skills as well as problem solving are key elements for this role.
Your Key Responsibilities:
1. Partners with team members in Regulatory Operational Excellence and stakeholders within and outside Sandoz Regulatory Affairs.
2. Leads strategic initiatives/programs in the matrix.
3. Builds strong interface within RA functions and QA, but also towards Development, Pharmacovigilance, Medical and TechOps and consultancy to country organizations/other functions as required.
4. Advocates a quality culture throughout Sandoz Regulatory Affairs.
5. Leads compliance projects and operational compliance tasks as assigned, including RA lead of Inspections and Audits.
6. Leads process transformation/improvements as assigned: e.g. manages the automation of data collection for reporting, gathering and reviewing high quality and meaningful commentary and provide dashboards and regular management update reports to Senior Management. Present KPI/KQI (Key Performance Indicators / Key Quality Indicators) data and insights to senior management and independently facilitate team / management meetings to discuss quality compliance and performance.
7. Leads the development of innovative solutions for effective tracking, management and oversight of key governance and compliance data (Metrics, Inspections, Escalations, Quality Issues, etc.).
8. Meets internal and external guidelines regarding quality and safety and promote and enforce compliance to such guidelines (Quality Manual, regulatory guidelines regulations, Health Authority guidance and SOPs).
9. Supports the collaboration with Business/Line functions and with Quality Assurance stakeholders to implement/maintain a metrics program that is fit for purpose, value added and considered an essential management tool for identifying and mitigating risk and for continuous process and quality system improvement.
10. In collaboration with QA and other stakeholders, establish and monitor inspection readiness, including quality and consistency measures.
11. Fully represents the department in Health Authority inspections/interviews, if needed.
What you’ll bring to the role:
1. University Degree, preferable Master in Bio-Medical / Life Sciences / Pharmaceutical sciences.
2. Extensive experience in the pharmaceutical industry + Regulatory Affairs (> 5 years).
3. Strategic leadership skills.
4. Strong influencer, negotiator, and collaborator in a matrix environment beyond function / area of expertise.
5. Understanding and experience of quality and compliance.
6. Understanding and experience with process optimization.
7. High change ability.
8. Ability to manage operational and strategic workload.
9. Prioritization and decision taking.
10. Communication skills for complex topics.
11. Result oriented.
12. High ethical standards.
13. Fluent in English (written and oral), German is an advantage.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provides more than 800 million patient treatments to over 700 million patients every 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 are 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!
Are you ready to join us? Then we look forward to your application!
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and fostering diverse teams, that represent the patients and communities we serve.
Join our Sandoz Network: 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, join the Network here: Sandoz Talent Pool
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