[Hiring] Senior Global GMP Quality Auditor @Novartis

Role Description

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. 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.

The Global GMP Senior Quality Auditor also ensures alignment with strategic direction of the company and assists in driving implementation of the applicable actions and provides consultation to Novartis business units through risk-based assessments.

Major Accountabilities

• 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.
• Handle complex and higher-risk audits, such as sterile API, aseptic DP, and combination products.
• 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 NVS requirements and timelines.
• Identify and report best practices and lessons learned to support development/training of GMP auditors.
• Mentor junior GMP staff as required.
• Act as GMP compliance consultant for GMP trainings, task forces, and continuous improvement projects.
• Ensure appropriate escalation to responsible management in case of critical findings.
• 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.
• Maintain current knowledge of regulations, standards, and guidance documents.

Qualifications

• 12+ years broad experience in Pharmaceutical or Medical Device Industry.
• 3 years auditing experience preferred.
• Excellent knowledge of regulatory requirements.
• Strong knowledge of GMP regulations.
• Solid operational experience, including QA/QC management and manufacturing.
• Strong experience in Sterile and/or expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Biologics, Microbiology, Computer System Validation, Quality Systems, Cell & Gene therapy, Radioligand therapy.
• Strong interpersonal skills, including diplomacy and persuasion.
• Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision.
• Fluent in English, written and spoken; other languages are a plus.

Desirable Requirements

• Experience and/or interaction with local Health Authority and sporadically with other Health Authorities is a plus.

Benefits

• Variety of competitive benefits in kind to help you thrive personally and professionally.
• Insurance plans.
• Retirement plans.
• Wellbeing resources.
• Global recognition programs.
• Flexible and hybrid working options, where possible.
• A minimum of 14 weeks paid parental leave.

Company Description

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. The rewards of being part of our team go far beyond base pay and incentives.