Senior Global GMP Quality Auditor

This is a fully remote position, open to applicants in Spain, +1 more country.

📋 Description

• Lead, support, and document independent GMP audits in accordance with the Novartis Quality System and current GMP regulations.

• Evaluate compliance with relevant regulations, standards, and guidance documents.

• Review and authorize corrective action plans addressing audit findings.

• Audit manufacturing facilities, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers.

• Assist in the strategic development of a global risk-based audit strategy and program.

• Plan, execute, document, and follow up on GMP audits.

• Conduct intricate and high-risk audits related to sterile API, aseptic DP, and combination products.

• Offer technical guidance, mentoring, and training regarding audit processes.

• Provide regulatory guidance for remediation and recommendations concerning filing acceptability.

• Prepare audit reports in line with Novartis requirements and timelines.

• Identify and communicate best practices and lessons learned.

• Serve as a GMP compliance consultant for training sessions, task forces, and continuous improvement initiatives.

• Escalate critical findings and support timely follow-up actions.

• Define and document mitigation plans when applicable.

• Evaluate audit finding responses and CAPA plans alongside QA representatives and auditees.

• Review and advise on pertinent policies and procedures.

• Maintain up-to-date knowledge of regulations, standards, and guidance documents.

⛳️ Requirements

• Over 12 years of extensive experience in the Pharmaceutical or Medical Device Industry.

• A minimum of 3 years of auditing experience is preferred.

• Excellent understanding of regulatory requirements.

• Strong knowledge of GMP regulations.

• Sound and practical judgment in interpreting and applying regulations and standards.

• Solid operational experience, including QA/QC management and manufacturing, development, or other relevant experiences such as working at a regulatory health authority.

• Substantial experience in Sterile and/or expertise in at least one of the following areas: DP Manufacturing, Laboratory activities, Medical Devices, API, Biologics, Microbiology, Computer System Validation, Quality Systems, Cell & Gene therapy, Radioligand therapy.

• Strong interpersonal skills, including diplomacy and the ability to persuade.

• Capability to independently manage and objectively assess complex compliance issues with minimal supervision.

• Fluent in English, both written and spoken.

• Experience and/or interaction with local Health Authority and occasionally with other Health Authorities is an advantage.

• Ability to work in Spain (Madrid or Barcelona) or Slovenia (Ljubljana).

• Willingness to travel up to 60% of the time.

🏝️ Benefits

• Relocation support.

• Insurance plans.

• Retirement plans.

• Wellbeing resources.

• Global recognition programs.

• Flexible and hybrid working options, where feasible.

• Minimum of 14 weeks of paid parental leave.

• Eligibility for performance-based bonuses.

• Global total rewards offering.