Lead, Quality Compliance

Job Description SummaryProvide successful strategic and managerial leadership for the site/supplier in all quality-related matters and ensure that key aspects of the operational business comply with cGxP. Provide guidance, support, and leadership to teams within the area of responsibility.Job DescriptionKey Responsibilities:Leads the Quality Systems, Regulatory and Compliance team. Manages team in day-to-day work activities and priorities to set and deliver team’s operational targets and compliance with all health, safety, and training procedures or requirements.Develops objectives for implementation of strategies and plans for site Quality Systems, Regulatory & Compliance team. Develop, coach, mentor, and engage team to build a high-performance team to meet team and group objectives.Ensures that site’s quality systems, compliance systems, and regulatory systems are established and maintained to support site operations.Cultivates site’s quality, data integrity, and speak-up culture.Active member of network harmonization teams and best practice platform establishment.Leads the site establishment, maintenance, and continuous improvement of designated Novartis quality systems and related procedures, ensuring compliance with Novartis policies, standards & procedures, and international regulatory and legislative requirements.Provides quality oversight on the department’s GMP training to ensure compliance with Novartis and local quality requirements.Leads the management of site’s systems/procedures related to regulatory activities and maintenance of site’s regulatory relevant licenses and permits, including supporting site in setting standards with regulatory relevant information included in both local and international regulatory/legislative requirements.Leads the management of site inspection-related activities, including (1) inspection readiness activities, (2) internal audit programs (Compliance Walkdowns/Self-Inspections/Corporate Audits), and (3) external inspections (Clients/Health Authorities). Manages post-inspection responses/actions and follows up with action owners to ensure compliance with requirements and timelines.Essential Requirements:12-15 years of experience in Pharmaceutical Manufacturing with adequate experience in QA Compliance/Quality System and Management role.Proven track record/practical experience in leading a quality section to ensure full compliance with global cGMP requirements. Successfully managed authority inspections from major HA’s e.g. FDA, EMA, HSA.Collaboration; result-oriented; problem-solving-oriented.Advanced communication skills; motivates colleagues and co-workers.Maintains exchange of experience in leadership and change management, objective setting, and performance management.Budget management, Operational Excellence, Risk Management, Project Excellence, Stakeholder Engagement, Organizational Savvy.Applied Business Insights. Additional qualification in the GMP area. Quality Assurance, Knowledge of GxP, Health Authorities, Supplier.Relationship Management; Strategic thinking and planning; Quality.Desirable Requirements:University degree with a scientific/technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent).Skills Desired:AuditingAudit ManagementCommunication SkillsCompliance AuditsCompliance RiskContinued LearningDealing With AmbiguityDecision Making SkillsGMP ProceduresInspection ReadinessOrganizational SkillsPeople Management and LeadershipQA (Quality Assurance)Regulatory ComplianceRisk ManagementSelf-AwarenessTechnological Expertise

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