- Contribute to the development of an effective risk-based audit strategy and programme.
- Lead, plan, perform, conduct, follow-up and document global quality regulatory compliance audits and assessments of pharmacovigilance and safety reporting practices within Novartis Pharma.
- Provide technical guidance and training on audit activities.
- Review, evaluate and approve proposed corrective and preventive action plans (CAPA) in collaboration with the responsible business unit. Contribute to generation of metrics.
- Monitor and track status of corrective and preventive actions to ensure that the issues are adequately addressed and completed.
- Drive closure of audits through close collaboration with auditees, involved business units and partners.
- Identify and communicate quality and regulatory compliance issues to DS&E QA management and DS&E management through appropriate channels.
- Provide assistance with the remediation of compliance concerns; determine effectiveness of remediation activities and provide on-going project support and governance, as assigned.
- Prepare for, facilitate and lead logistics for Health Authority (HA) PV inspections; assess re-sults of pre-inspection preparation activities and HA inspection findings in terms of associated risks and communicate to management; provide input to CAPA to ensure quality, consistency and appropriateness of commitments.
- Through evaluation of audit and assessment results, assist in the identification of specific regulatory, compliance and quality assurance training needs for business partners and participate in the development, implementation and conduct of appropriate training.
- Support DS&E with compliance investigations and initiatives focused on inspection readiness and quality, process and compliance improvement.
- Review and advise on relevant guidelines, policies, Novartis Internal Procedures (NIPs) and SOPs (Standard Operating Procedures). Minimum requirements • BA/BS or equivalent.
- English fluency at operational and functional level (as first or second language; second language a plus).
- 3-5 years PV/clinical/industry/health authority experience.
- 1-2 years of GCP/PV auditing experience.
- Willingness to travel approx. 40% of the time.
- Ability to manage and objectively evaluate compliance issues.
- Ability to address a variety of tasks within the same timeframe while maintaining oversight.
- Maintain a moderate degree of independence with respect to decision making and problem solving.
- Experience with Health Authority inspections and interaction.
- Good quality and compliance leadership and facilitation skills.
- Excellent verbal and written communication, organizational and interpersonal skills.
- Excellent computer skills, including Excel, Word, etc.
- Thorough knowledge of applicable PV, GCP and GxP regulations, guidelines, policies and procedures.
- Good knowledge of computer validation and Part 11 requirements.
- Ability to operate successfully in various team capacities, including leader and/or active member.
- Ability to operate successfully in various cultural environments.
- Auditor certification a plus.
Novartis - 13 months ago
Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research, d...