The Senior GCP / PV Auditor and Outsourcing is responsible for leading, supporting, and reporting on independent GCP / PV audits according to the NVS Quality System and current GCP / PV regulations to assess compliance with applicable regulations, standards, and guidance documents. This role involves reviewing and approving corrective action plans in support of audit observations.
Ensure alignment with the company's strategic direction and assist in implementing applicable actions. Provide consultation to NVS business units through risk-based assessments. Act as SME for assigned areas of responsibility.
The incumbent will manage and oversee audits, including outsourced audits, with a reduced number of direct reports to accommodate this responsibility. Develop and maintain a standard process for contracting and overseeing GCP / PV audits with third-party providers.
About the Role
We are seeking talented individuals across Spain! This position offers full remote work with location flexibility. We welcome applicants whether based in Madrid or Barcelona.
Please note that travel up to 40% may be required.
Major accountabilities :
* Support the development of a global risk-based audit strategy and program; gather and incorporate input into audit planning.
* Lead, plan, conduct, document, and follow up on global GCP / PV compliance audits according to Novartis Quality standards and regulations. Perform activities independently.
* Provide guidance, leadership, mentoring, and training to other auditors.
* Prepare audit reports per NVS requirements and timelines.
* Escalate critical findings to management and support immediate follow-up actions.
* Assess responses (CAPA plans) to audit findings with CAPA team.
* Identify and communicate compliance issues and recommend remediation.
* Lead investigations and initiatives on inspection readiness and quality improvement.
* Support inspections by authorities and mock audits as needed.
* Review and advise on relevant policies and procedures.
* Research global initiatives and trends affecting compliance.
* Mentor junior staff as required.
* Participate in Lead Auditor programs as needed.
Major Accountabilities for Management and Oversight of Outsourced Audits :
* Ensure third-party auditors comply with Novartis requirements.
* Provide strategic and operational support for outsourced audits.
* Create and maintain processes for outsourcing governance.
* Manage and oversee third-party audit firms, including KPIs & KQI oversight.
* Support third-party auditors during audit preparation and conduct.
* Manage audit reports, post-audit discussions, and CAPA approvals.
Obligatory requirements :
* Degree in natural/biological sciences or equivalent; advanced degree preferred.
* Minimum 5 years of GCP / PV / clinical / industry / health authority experience; 1-2 years of GCP auditing preferred.
* Certified Auditor is mandatory.
* Ability to evaluate compliance issues objectively and manage multiple tasks independently.
* Thorough knowledge of GCP, PV, and GxP regulations, guidelines, policies, and procedures.
* Experience with health authority inspections and interactions.
* Strong leadership and facilitation skills.
* Fluent in English, both written and spoken; other languages are a plus.
Why Novartis : Join us to help people with diseases. We foster a community of passionate, innovative, and collaborative professionals dedicated to changing patients’ lives.
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Novartis is committed to an inclusive, diverse work environment that reflects the communities we serve.
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