Global Senior GCP Auditor

Job Description Summary

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

Lead, support and report independent GCP audits according to the Sandoz Quality System and the current GCP 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.

Job Description

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 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 GCP compliance consultant for GCP 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 GCP 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 GCP auditors.

What you’ll bring to the role:

Essential Requirements:

• Graduate or Post-graduate in Chemistry, Pharmacy, Biology, Engineering or another related science
• Advanced degree preferred - Other degrees with relevant experience may be accepted

• 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.

• 3-5 years auditing experience preferred, and excellent knowledge of regulatory requirements.

• Willingness to travel approximately 60% of the time.

• Expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Excipients, Sterile, Biologics, Microbiology, Computer System Validation, Packaging activities, Quality Systems.

• Experience and/or interaction with local Health Authority and sporadically with other Global Health Authorities.

• Strong interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with Sandoz colleagues, vendors and customers.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, 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 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 supported! 

Join us!

Skills Desired

Agility, Agility, Auditing, Audit Management, Business Acumen, Business Partnering, Collaboration / Teamwork, Communication Skills, Compliance Audits, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Employee Performance Evaluations, Finance Acumen, Gmp Procedures, Goal-Oriented, Health Authorities, Inspection Readiness, Leadership, Logical Thinking, Major Incident Management, Organization Skills, People Management, Problem Solving Skill, Problem Solving Skills {+ 5 more}