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Location

Holzkirchen, Landkreis Miesbach | Germany

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Job description

About the role

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:

 Implement the quality strategy within CTT/Clinical Subteams/Global Program Teams under responsibility, as assigned.
 Regularly monitor the implementation of the annual Quality Plan pertaining to the Clinical chapter and ensure that all delayed activities have a documented rational and appropriate escalation.
 Ensure proactive quality risk management process including quality risk assessments and submission/inspection readiness activities and ensure that processes are in control.
 Provide robust and clear quality oversight in the following areas of clinical development:
 Proactively support / collaborate with key stakeholders to ensure that risks are detected and remediated.
 Establish/ lead core governance for deviation/incident management for critical or major deviations pertinent to the programs being assigned.
 Provide GCP guidance to day to day questions arising from Clinical trials deliverables, as well as participate in review and approval of critical Clinical Study documents (e.g., Protocols), as defined.
 Collaborate with Development Operations QA to drive initiatives relevant to internal monitoring and outsourced activities.
 Quality oversight of internal and outsourced clinical development activities and collaboration with involved business partners.
 Support inspection management (preparation, hosting, follow-up) in collaboration with other QA groups including but not limited to Sandoz Development QA.
 Support audit planning, management and follow-up; Participate in audits, as assigned.
 Identify and lead continuous improvement initiatives (including Work streams) and ensure that areas identified as weaknesses are properly being addressed and executed for sustainability. Support SOP review as assigned, as well as support GCP training as assigned.
 As assigned, and as designate, represent the main CQA point of contact for Biosimilars and attend the key governance Leadership meetings and ensure that Quality discussions are part of the key agenda topics on a monthly and quarterly basis to support the QRB meetings.
 Support Quality Management System aspects for Biopharma, such as QA membership in QMS Governance and oversight of maintenance of a robust and compliant Development QMS.

Role Requirements

What you’ll bring to the role:
Essential Requirements:
 Bachelor’s degree in Life Sciences, Pharmacy or Medicines
 At least 3 years of involvement in regulated activities (GCP/PV), clinical development and/or QA positions.
 Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product development.
 Ability to work independently and in a global/matrix environment.
 One or more years’ experience in managing projects.
 Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors.
 Strong skills in GCP, quality and/or clinical development. Experience with managing Authority inspections, desirable. Auditing Experience desirable
 Strong interpersonal, communication, negotiation, and problem-solving skills.
 Fluent in English language skills; knowledge of other languages (e.g. German) are a plus

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.

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

The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Join our Sandoz Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Sandoz and our career opportunities, join the Sandoz Network here:

#Sandoz

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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Salary