Job Description Summary
Manage cost-effective GxP Compliance and/or Audit activities, operations, and systems to ensure compliance of business areas with the Novartis Quality Manual, Policies, and all relevant GxP, legal, and regulatory requirements. This includes conducting internal audits, monitoring KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators).
Job Description
Major accountabilities:
* Planning and supporting PQR/APQR activities.
* Supporting site qualification and validation activities (planning, advising, review).
* Implementing Quality Systems (including documentation management).
* Managing supplier activities (agreements, oversight, audits).
* Preparing, supporting, and coordinating CAPA and follow-up actions.
* Preparing for and supporting audits and inspections.
* Reviewing and approving change controls.
* Ensuring local DI and eCompliance oversight (training, inspections, planning, risk identification).
* Ensuring process quality assurance and compliance with regulations.
* Reviewing and approving QP declarations.
* Monitoring KPI trending.
* Managing applications, certificate maintenance, and communication with Health Authorities (HA).
* Acting as SPOC for communication with HA, GCA, and ensuring a consolidated approach across sites within the same HA jurisdiction.
* Reporting technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours.
* Distribution of marketing samples where applicable.
Key performance indicators:
* Successful support of projects with quality and delivery targets met, passing internal and external inspections.
* Adherence to quality standards and timelines.
* Minimization of cGMP issues during audits.
* Year-end figures within budget.
* Effective coordination of departmental operational activities.
Minimum Requirements:
Work Experience:
* Functional breadth and cross-boundary collaboration.
* Project management experience.
* People leadership skills.
Skills:
* Audit management and auditing skills.
* Excellent communication skills.
* Experience with compliance audits and understanding compliance risks.
* Commitment to continuous learning and dealing with ambiguity.
* Strong decision-making skills.
* Knowledge of GMP procedures and inspection readiness.
* Organizational and people management skills.
* Quality assurance and regulatory compliance expertise.
* Risk management and self-awareness.
* Technological proficiency.
Languages:
* English.
Skills Desired: Auditing, Audit Management, Communication Skills, Compliance Audits, Compliance Risk, Continued Learning, Dealing With Ambiguity, Decision Making Skills, GMP Procedures, Inspection Readiness, Organizational Skills, People Management and Leadership, Quality Assurance, Regulatory Compliance, Risk Management, Self-Awareness, Technological Expertise.
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