SUMMARY

Conduct and support GLP/GCLP audits, including integrations and non-GxP assessments, following the Novartis Quality System and current regulations. Ensure compliance with applicable standards and guidance documents. Review and approve corrective action plans for audit observations.
Ensure alignment with strategic direction of the company and assist in driving implementation of the applicable actions. Provide consultation to Novartis business units through risk-based assessments. Act as a subject matter expert for assigned areas of responsibility.

MAJOR ACCOUNTABILITIES:

• Support the strategic development of an effective global risk-based audit strategy and program; collect, collate, and incorporate input into audit strategy and plan.
• Lead, plan, conduct, document and follow-up of global quality regulatory compliance audits of GLP/GCLP according to the requirements specified in the respective Novartis Quality Module. Assess the adequacy of responses (CAPA plans) to audit findings.
• Conduct assessments for companies and their vendors during BD&L integration activities including non-GxP assessments, which include, but not limited to data reviews, IT system evaluations.
• Provide technical guidance, leadership, mentoring and training of other auditors on audit related activities.
• Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures accordingly.
• Identify and communicate quality and regulatory compliance issues to Quality Management and recommend remediation.
• Liaise as needed with the third-party management team.
• Proactively research local and global initiatives, trends and events that impact maintenance of compliance. Maintain current knowledge of regulations, standards and guidance documents.

WORK EXPERIENCE:

• 7+ years of GLP/GCP/Pharmaceutical Industry/Health Authority experience or equivalent.
• 5 years of GCP/PV auditing experience

SKILLS:

• Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision.
• Experience with Health Authority inspections
• Excellent verbal and written communication, organizational and interpersonal skills.
• Knowledge of applicable GxP regulations, guidelines, policies, and procedures.
• Good knowledge of computer systems validation and 21CFR Part 11 requirements.
• Leadership and facilitation skills
• International travel expectation 25%.