Lead - QSRC (Quality System Regulatory Compliance)

Overview Lead - QSRC (Quality System Regulatory Compliance) at Novartis Singapore. Provide strategic and managerial leadership for the site / supplier in all quality related matters and to ensure that key aspects of the operational business comply with cGxP. Provide guidance, support and leadership to teams within area of responsibility. 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 ensure 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 the team to build a high performance environment that meets 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 for 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 systems comply with Novartis policies, standards & procedures, and international regulatory and legislative requirements, as required. 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 as required, including supporting site in setting standards with regulatory relevant information included in both local and international regulatory / legislative requirements, as required. Leads the management of site inspection related activities, such as inspection readiness, internal audit programs (Compliance Walkdowns / Self-Inspections / Corporate Audits) and external inspections (Clients / Health Authorities). Leads the management of post-inspection responses / actions and follow up with action owners to ensure responses / actions meet requirements and timelines. Essential Requirements 12-15 Years of experience in Pharmaceutical Manufacturing with adequate experiences 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 Health Authorities (e.g. FDA, EMA, HSA). Collaboration; result-oriented; problem-solving-oriented. Advanced communication skills; motivates colleagues and co-workers. Maintains exchange of experience 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). Why 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? Join 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: Benefits and Rewards Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Seniority level Director Employment type Full-time Job function Other Industries Pharmaceutical Manufacturing #J-18808-Ljbffr