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Head Gxp Compliance And Health Authorities Inspection Support

15+ years
Not Disclosed
10 March 4, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Head GxP Compliance and Health Authorities Inspection Support

Job ID: REQ-10033976
Location: Barcelona Gran Vía, Spain (Alternative Locations: Hyderabad, India / Ljubljana, Slovenia)
Category: Quality
Business Unit: Innovative Medicines
Job Type: Full-time, Regular
Company: Novartis Farmacéutica, S.A.

Role Summary:

The Head of GxP Compliance and Health Authorities Inspection Support ensures GxP compliance across Novartis, aligning with evolving regulatory landscapes. This role supports Health Authority Inspections (HAIs), audits, and compliance initiatives, and leads efforts to establish a GxP compliance framework for Artificial Intelligence (AI) applications within Novartis.

Key Responsibilities:

Health Authority Inspections & Compliance Support:

  • Provide training and support for inspection readiness before and during Health Authority Inspections (HAIs) and audits.
  • Review HAI observations, ensure remediation activities are implemented and effectiveness is verified.
  • Participate in global aseptic and ATMP expert networks, reinforcing aseptic area training and best practices.
  • Contribute to Quality Management System (QMS) and risk management initiatives.

Artificial Intelligence & GxP eCompliance Framework:

  • Actively contribute to GenAI governance and initiatives.
  • Develop a robust GxP eCompliance framework for AI applications within Novartis.
  • Monitor AI regulatory landscapes and mitigate compliance risks.

Regulatory Intelligence & Quality Governance:

  • Liaise with Regulatory Affairs (RA) Policy teams on emerging guidelines and ensure gap assessments are conducted.
  • Support QMS governance activities and participate in QMS network meetings.
  • Ensure SOP updates are monitored and aligned with role responsibilities.
  • Participate in escalation meetings and provide investigation support for GMP compliance gaps.

Qualifications & Experience:

Essential Requirements:

  • Undergraduate degree in a scientific discipline; graduate degree preferred.
  • 15+ years of experience in the pharmaceutical or biopharmaceutical industry in Operations and Quality Assurance (QA).
  • Strong experience in sterile operations and/or Advanced Therapy Medicinal Products (ATMPs).
  • Expertise in investigations, data integrity detection, and compliance.
  • Experience with eCompliance regulations and AI regulatory landscapes.
  • 5+ years of experience handling Health Authority Inspections (HAIs) and audits.
  • Strong project management, communication, and leadership skills.
  • Global travel availability (minimum 25%).
  • Fluent English (additional languages are a plus).

Why Novartis?

At Novartis, we strive to reimagine medicine and improve lives through innovation, collaboration, and passion. Join us to shape the future of healthcare!