Associate Director Operational Excellence - Munich, Deutschland - Hexal AG

Hexal AG

Geprüftes Unternehmen

Munich, Deutschland

vor 4 Stunden

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now 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 Founder of our 'new' Sandoz

Your Key Responsibilities:

Your responsibilities include, but not limited to:

Build a strong Compliance culture within the Biopharmaceuticals Technical Development (BTD) organization, aligned with Sandoz global Quality and Data & Systems Governance.
Drive a culture of quality in development implementing the strategy, mission and vision of BTD within Sandoz Global Development.
Be responsible for good documentation practices and compliance within the technical development units in line with Health Authorities' requirements. Ensure all internal compliance standards are met with full adherence to the principles of Data Integrity for people, processes and equipment.
Provide robust and clear compliance governance & oversight in areas of development laboratory activities proactively supporting internal key stakeholders to ensure compliance to the company internal development quality standards.
Identify, shape and lead / coordinate continuous improvement initiatives (including work streams), and ensure that areas identified as weaknesses are properly being addressed and sustainably and lastingly improved.
Provide comprehensive advice as a goto person on a wide range of compliance and data integrity topics, prepare line functions for audits (authorities or internal) prepare and perform inspection readiness checks, gap analysis and action lists, and guide implementation teams on the shop floor
Coordinate collection, reporting and presenting key performance indicators for compliance & Data Integrity
Initiate, lead and influence new compliance enabling programs, as well as identify and address complex issues across line functions within Technical Development.
Evaluate and implement new approaches and methodology to identify and solve issues, in close alignment with other expert departments

Diversity and Inclusion

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

Minimum Requirements

What you'll bring to the role:

Essential Requirements:

D. in a technical discipline (4+ years of experience) or Degree in Life Science discipline (8+ years of experience).

Successfully demonstrated several years (minimum of 3 years) of directly related experience as Compliance Lead or equivalent, preferably in the field of technical development of Biologics/biosimilars.
Fluent knowledge of English (spoken and written).
Deep understanding of processes in technical development of Biopharmaceuticals.
Thorough knowledge of guidelines that are relevant for biopharmaceutical and biosimilar development.
Strong leadership, coaching and mentoring skills, as well as advanced communication and presentation skills.
Strong track record of innovation, creativity, problem solving and continuous improvement in projects.
Experience in preparation and execution of audits by authorities or customers
Strong track record of major contributions to biopharmaceutical / preferably biosimilar development projectsand strategic activities / improvement projects in the field of quality and compliance, data integrity and data management.

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.

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.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

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