Novartis

Global Senior Quality Auditor

Novartis

full-time

Posted on:

Location Type: Office

Location: Barcelona • Spain

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Job Level

Senior

About the 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.
  • 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 and provides consultation to Novartis business units through risk based assessments.
  • Travel up to 60% of time.
  • 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 Novartis Quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents.
  • 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.

Requirements

  • 12+ years broad experience in Pharmaceutical or Medical Device Industry.
  • 3 years auditing experience preferred, and excellent knowledge of regulatory requirements.
  • Strong knowledge of GMP regulations , 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 e.g. working at a regulatory health authority.
  • 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, used in obtaining cooperation and consensus with Novartis 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.
Benefits
  • Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GMP auditingregulatory compliancecorrective action plansrisk-based assessmentsaudit strategy developmenttechnical guidancementoringquality agreementsComputer System ValidationQA/QC management
Soft Skills
interpersonal skillsdiplomacypersuasionindependent managementobjective evaluationcommunicationconsultationteam collaborationtrainingproblem-solving