Job Description Summary
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. This role involves assessing compliance with applicable regulations, standards, and guidance documents, reviewing and approving corrective action plans, and ensuring alignment with the company's strategic direction. The incumbent will also provide consultation through risk-based assessments and act as a Subject Matter Expert (SME) in assigned areas.
The position includes management and oversight of audits, including outsourced audits, with a reduced number of direct reports to accommodate these responsibilities. Additionally, the role may involve developing and maintaining standard processes for contracting and overseeing third-party GCP / PV audit service providers.
We pursue amazing talent across Spain! This position offers the possibility of being fully remote, with flexibility in location. We welcome candidates based in Madrid or Barcelona .
Please note that the role requires travel of up to 40% of the time.
Major accountabilities include :
* Supporting the development of a global risk-based audit strategy and plan.
* Leading, planning, conducting, documenting, and following up on GCP / GPvP compliance audits.
* Providing guidance, mentorship, and training to other auditors.
* Preparing audit reports and ensuring timely escalation of critical findings.
* Assessing responses to audit findings and recommending remediation.
* Leading compliance investigations and supporting inspection readiness activities.
* Reviewing and advising on global policies and procedures.
* Proactively researching relevant initiatives and trends.
* Mentoring junior staff and participating in the Lead Auditor program.
Management and Oversight of Outsourced Audits :
1. Ensuring third-party auditors comply with requirements.
2. Providing strategic and operational support for outsourced audits.
3. Creating and maintaining processes for governance of the outsourcing program.
4. Managing contracted third-party audit firms and overseeing KPIs and reporting.
Obligatory requirements include :
5. Degree in natural / biological sciences or equivalent; advanced degree preferred.
6. Minimum 5 years of GCP / GPvP / clinical / industry / health authority experience, with 1-2 years of GCP auditing preferred.
7. Certified Auditor is mandatory.
8. Ability to evaluate compliance issues objectively and handle multiple tasks independently.
9. Thorough knowledge of applicable GCP, GCPvP, and GxP regulations, guidelines, policies, and procedures.
10. Experience with health authority inspections and interactions.
11. Strong leadership, communication, and compliance management skills.
12. Fluent in English, written and spoken; additional languages are a plus.
Skills Desired :
Agility, Auditing, Audit Management, Business Acumen, Collaboration, Communication Skills, Compliance Audits, Decision Making, Leadership, Problem Solving, Organization Skills, People Management, Inspection Readiness, etc.
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