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!

Position Purpose:
Lead, support and report independent GCP/PV audits according to the Sandoz Quality System and the current GCP/PV regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations. The audits performed include internal and external targets of manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers.

Ensure alignment with strategic direction of the company and assist in driving implementation of the applicable actions. Provide consultation to Sandoz business units through risk based assessments. Act as SME for assigned areas of responsibility.

Your Key Responsibilities:
Your responsibilities include, but not limited to:

• Support the strategic development of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan.
• Plan, lead, conduct, document, and follow-up of GCP/PV audit according to the requirements specified in the respective Sandoz Quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents.
• Provide technical guidance, mentoring, and training on audit activities.
• Prepare audit reports according to Sandoz requirements and timelines.
• Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to Sandoz requirements on Management Escalations and other relevant procedures. Ensure adequate definition and recording of mitigation plans when applicable.
• Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with Follow up Responsible Person (FURP) and Quality Responsbaile Person (QARP).
• Suppport Mock Pre-Approval Inspections (PAIs) and Health Authority (HA) inspections as needed.
• Review and advise on relevant policies and procedures.
• Maintain current knowledge of regulations, standards, and guidance documents.
• Identify and report best practices and lessons learned to support development/training of GCP/PV auditors.

Role Requirements

What you\'ll bring to the role:

• Degree in Natural Science
• At least 7-8 years of experience in regulated Pharmaceutical Industry, and 3-4 years of GCP/PV Auditing experience. Experienced in both GCP and PV Auditing is ideal
• Willingness to travel approximately 60% of the time
• The operational experience should include QA/QC management and manufacturing, or development or other relevant experience e.g. working at a regulatory health authority
• Extensive knowledge of applicable GCP, PV and GxP regulations ,guidelines, policies and procedures. Experience with Health Authority inspections and interaction.
• Strong interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with Sandoz colleagues, vendors and customers.
• Sound and practical judgement in the interpretation and application of regulations and standards. Fluent in English written and spoken, other languages 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.

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
Talentpool (novartis.com)
#Sandoz

Functional Area

Quality

Division

SANDOZ

Business Unit

NON-NVS TSA QUALITY STO

Employment Type

Regular

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.

Shift Work

No

Early Talent

No

Novartis