Laboratory Auditor

Job Description
SummaryConduct and support GLP/GCLP audits, including integrations and non-GxP assessments, following the Novartis Quality System and current regulations. Review and approve corrective action plans for audit observations.
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.
Proactively research local and global initiatives, trends and events that impact maintenance of compliance. 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.3+ years of GxP auditing experience. GCP/PV/GLP auditing experience preferred.
International travel expectation 25%undefinedSkills:Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision.
Languages:English.
Additional languages including German and French considered a plusCommitment to Diversity & Inclusion: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 ** and let us know the nature of your request and your contact information. Novartis tiene el compromiso de trabajar y proporcionar adaptaciones razonables para personas con discapacidad. Si, debido a una condición médica o discapacidad, necesita una adaptación razonable para cualquier parte del proceso de contratación, o para desempeñar las funciones esenciales de un puesto, envíe un correo electrónico a ** y permítanos conocer la naturaleza de su solicitud y su información de contacto. Why Novartis:Helping people with disease and their families takes more than innovative science. DesiredAuditing (Inactive), Audits Compliance, Business Partnerships, Commercial Acumen, Communication, Continuous Learning, Decision Making, Employee Performance Evaluations, Financial Acumen, Gmp Procedures (Inactive), Goal-Oriented, Group Problem Solving, Health Authorities (Inactive), Leadership, Logical Thinking, Major Incident Management, Managing Ambiguity, People Management, Qa (Quality Assurance) (Inactive), Self-Awareness, Smart Risk Taking (Inactive), Speed and Agility Training (Inactive), Stakeholder Management, Teamwork, Technical Knowledge#J-*-Ljbffr