摘要
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.
About the Role
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.
Key performance indicators:
- Complete audits/assessments promptly and accurately.
- Ensure findings and reports meet timelines, procedures, and Key Quality Indicators (KQIs).
- Analyze audit metrics and non-compliance causes effectively.
- Escalate issues through proper channels promptly.
- Communicate and support business partners thoroughly and accurately.
Minimum Requirements:
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%.
Languages :
- English.
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Accessibility and accommodation
Novartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
