Global GxP Expert Auditor

Sep 09, 2021

Job Description

Global GxP Expert Auditor

How would you like to be a key part of the Global Auditing at Novartis, building upon and maintaining our exceptional standards?

As Global GxP Expert Auditor, you will be responsible for leading, supporting and reporting independent GCP/PV audits according to the Novartis Quality System and the current GCP/PV regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective ac-tion plans in support of the audit observations. The audits performed on behalf of Global GxP Audit include internal and external targets of country organizations, exter-nal services providers, process and quality systems, laboratories, investigator site, for-cause and mock pre-approval inspections Align strategic direction with senior leaders of Novartis and help establish programs to implement

Your responsibilities include, but not limited to:
1. Contribute to establishing the strategic direction of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan.

2. Plan, lead, conduct, document, and follow-up of GCP/PV audit according to the requirements specified in the respective Novartis Quality Module as well as appli-cable regulations, standards, quality agreements, and guidance documents.

3. For this expert role, the leader in this position is able to audit complex and high-risk sites and activities. The leader in this position is considered an expert and SME and will perform pre-approval/pre-submission project reviews, “mock” pre-approval inspections across GDD and/or external entities in accordance with the standards defined in the Novartis Quality Manual, the Novartis Audit Manual, and national/international GxP requirements.

4. Provide technical guidance, mentoring, and training on audit activities.

5. Ensure appropriate escalation to responsible management in case of critical observations and support immediate follow-up measures according to Novartis requirements on Management Escalations and other relevant procedures. En-sure adequate definition and recording of mitigation plans when applicable.

6. Assess the adequacy of responses (CAPA plans) to audit findings in coopera-tion with the Follow-up Responsible Person (FURP) and Auditee (Quality Re-sponsible Person, QARP).

7. Act as GCP/PV compliance consultant for GCP/PV trainings, task forces, con-tinuous improvement projects as needed.

8. Review and advise on relevant policies and procedures.

9. Proactively research local and global initiatives, trends, and events that affect maintenance of compliance.

10. Mentor junior GCP/PV staff as required. Ability to perform training for non-certified and junior GCP/PV staff.

11. Maintain current, expert knowledge of regulations and elaborate best prac-tices auditing guideline (when applicable). Support development/training of GCP/PV auditors.

12. Support HA commitments and global commitments/initiatives as an outcome of inspection findings.

13. Provide training on audit and inspection techniques across Novartis.

14. Flexible and proactive in developing new audit techniques.

15. Active contributor and participant for the auditor certification program by mentoring and assessing junior auditors across the company.

16. Review and approve audit reports as required.

17. Participate in the Lead Auditor program as required.

18. Act as Deputy for Regional Head as required.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

- Degree in natural/biological sciences or equivalent (or an equivalent mix of education and experience). Advance degree desirable

- English Fluent at operational and functional level (as first or second language; second language is preferred)

- 12+ years GxP experience in Pharmaceutical In-dustry/Health Authority experience or equivalent; 5 years of GCP/PV auditing experience; including preferably auditor certification by an industry rec-ognized body (e.g. ASQ) and excellent knowledge of regulatory requirements.
- Expertise in one or more of the GxP disci-plines, i.e., GCP/PV/GLP/GMP · Willingness to travel approximately 60% of the time

- Experience and/or interaction with local Health Authority and sporadically with other Health Au-thorities.

- Excellent interpersonal skills, including diplo-macy and persuasion, used in obtaining coop-eration and consensus with Novartis colleagues, vendors and customers. The Associate must be able to effectively represent the department both internally and externally.

- Sound and practical judgement in the interpre-tation and application of regulations and stand-ards

-Ability to independently manage and objectively evaluate complex compliance issues with mini-mal supervision

- Excellent leadership and facilitation ·

- Good knowledge of computer systems validation and 21CFR Part 11 requirements

You’ll receive: Company Pension Plan; Life and Accidental Insurance; Meals Allowance or Canteen in the office; Flexible working hours

Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:

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Novartis Technical Operations
Full Time
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Global GxP Expert Auditor

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