QA Compliance Lead

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 area of responsibility.About The RoleMajor accountabilities: OperationalCollaboration in GxP audits/inspectionsOversight and implementation of Quality Management SystemIncident managementGxP Audit and inspection managementSite Regulatory oversight (incl. Reg-CMC facilitation)Exception managementSupplier Quality management (local)Qualification and validationQuality ComplianceSupport the QA operation team and product release during project phaseResponsible for deviation handlingResponsible for Change Control managementResponsible for system improvingLeadership & CultureDrives the talent agenda: Leads people processes through recruitment, training, coaching and performance to meet all operation requirements and supports a robust career path deployment and succession plan for area of responsibilityInvest time in personally developing and coaching talentsActively support and promote talent exchange for the benefit of the individuals and organizationEnsure the consistency between career development processes and the business strategySupport the T&L organization by identifying and reviewing the appropriate list of training for all in-scope associatesEnsure that associates are qualified for a GMP task prior to independent performanceMonitor overall training compliance for in-scope associatesIdentify and maintain a list of subject matter experts for in-scope areas of expertiseCreate a work environment that enables high employee engagementRole model the culture aspiration of being Curious, Inspired and Un-bossed and ensure leaders and associates are aware and aligned on expectations and hold them accountable for success of culture journeyHSEPromote and improve the Safety and Quality cultures, by implementing the necessary systems and actions in line with the evolution of the siteEnsure overall inspection readiness for area of responsibility.Guarantee the effectiveness of the Business Continuity Plan within area of responsibilityResponsible for participating in initial training and retrainingHSE incidents reporting & action follow-upKey Performance Indicators Successful oversight and implementation of Quality Management SystemCarry out improvements in GMP complianceException and Incident managementRelevant ExperienceSeveral years of experience (> 3 years) in the field of GMP production or QA or QC Professional experience from official and / or customer audits Expertise in GMP (sterile/non-sterile)Functional Breadth; People Leadership; Organization Scope; Scale and Complexity; Collaborating across boundaries; Project ManagementEducation & QualificationUniversity degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)LanguagesFluent (oral and written) in English; good in local language (oral and written)CompetenciesCollaboration; result-oriented; problem-solving-orientedAdvanced communication skills; motivates colleagues and co-workersMaintains exchange of experienceLeadership and change management, objective setting and performance managementBudget management, Operational Excellence, Risk ManagementProject Excellence; Stakeholder Engagement; Organizational Savvy; Applied Business InsightsAdditional qualification in the GMP areaQuality Assurance; Knowledge of GxP, Health Authorities, Supplier Relationship Management; Strategic thinking and planning; Quality decision making; Interdepartmental collaboration; Communication skills; Problem-solving-oriented; Goal-orientedMS Office applications and other standard IT applications supporting Quality activitiesWhy Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureJoin our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/networkBenefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards