Global Senior GMP Auditor

At Sandoz, our goal is not just to increase access, but to do so in a sustainable and responsible way:

finding the right balance between guaranteed quality, reliable supply and appropriate pricing. Our aim is to excel at all three, ensuring we never compromise on quality.

to protect our environment (carbon footprint, natural resources), as well as to champion diversity, equity and inclusion across our company and beyond

As GMP Senior Auditor you'll lead, support and report independent GMP audits according to the Sandoz Quality System and the current GMP 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.

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 GMP audit according to the requirements specified in the respective Sandoz Quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents.

For this role, auditors will be given more complex and higher-risk audits, such as sterile API, aseptic DP, and combination products. The ability to assess risk of these operations is critical to success.

Provide technical guidance, mentoring, and training on audit activities.

Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing.

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 the stakeholder QA representative and Auditee.

Act as GMP compliance consultant for GMP trainings, task forces, continuous improvement projects as needed. Assure permanent transfer of best practice identified during the audit into Sandoz QMS system

Review and advise on relevant policies and procedures.

Mentor junior GMP staff as required.

Maintain current knowledge of regulations, standards, and guidance documents.

Identify and report best practices and lessons learned to support development/training of GMP auditors.

Degree in Chemistry, Pharmacy, Biology, Engineering or another related science. Advanced degree preferred. Other degrees with relevant experience may be accepted

Excellent oral and written English communication skills. Good knowledge/mother tongue of an additional language (e.g. German, French, Italian, Chinese, or Spanish) is valued.

At least 10 years broad experience in Pharmaceutical or Medical Device Industry.

The operational experience should include QA/QC management and manufacturing, or development or other relevant experience e.g. working at a regulatory health authority.

3 years auditing experience preferred, and excellent knowledge of regulatory requirements.

Expertis…