Global GMP Senior Quality Auditor

20h20 hours ago

Novartis

ES · Full-time · €65,000 – €95,000

About this role

In this role you will lead, support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents.

You will plan, lead, conduct, document, and follow-up GMP audits targeting manufacturing sites, development centers, contract manufacturers, laboratories, warehouses, and suppliers. Review and approve corrective action plans in support of audit observations.

The Global GMP Senior Quality Auditor ensures alignment with strategic direction of the company and provides consultation to Novartis business units through risk based assessments. Travel up to 60% of time is required, with base options in Spain or Slovenia.

You will receive more complex and higher-risk audits such as sterile API, aseptic DP, and combination products. Provide technical guidance, mentoring, and training on audit activities while acting as GMP compliance consultant for trainings and continuous improvement projects.

Requirements

12+ years broad experience in Pharmaceutical or Medical Device Industry with 3 years auditing experience preferred.
Strong knowledge of GMP regulations with sound and practical judgement in the interpretation and application of regulations and standards.
Solid operational experience that should include QA/QC management and manufacturing, development or other relevant experience.
Strong experience in Sterile and/or expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, API, Biologics, Microbiology, Computer System Validation, Quality Systems, Cell&Gene therapy.
Strong interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with colleagues, vendors and customers.
Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision.
Fluent English, written and spoken. Other languages are a plus.

Responsibilities

Support the strategic development of an effective global risk-based audit strategy and program.
Plan, lead, conduct, document, and follow-up of GMP audits according to Novartis Quality procedures and applicable regulations.
Provide technical guidance, mentoring, and training on audit activities for complex operations including sterile API and aseptic DP.
Prepare audit reports according to NVS requirements and timelines while identifying best practices and lessons learned.
Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures.
Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the stakeholder QA representative and Auditee.
Review and advise on relevant policies and procedures while maintaining current knowledge of regulations, standards, and guidance documents.