摘要
About the Role
Key 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.
- Cultivate 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 esignated Novartis quality systems and related procedures, and ensure that the systems comply with Novartis policies, standards & procedures, and international regulatory and legislative requirements, as required.
- Provide quality oversight on the department’s GMP training to ensure that for department’s GMP training complies 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, but not limited to, (1) inspection readiness activities, (2) internal audit programs (Compliance Walkdowns / Self-Inspections / Corporate Audits) and/or (3) external inspections (Clients / Health Authorities). Leads the management of post inspection responses / actions and follow up with action owner(s) to ensure such responses / actions meets requirements and committed 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 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 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? https://www.novartis.com/about/strategy/people-and-culture
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: https://talentnetwork.novartis.com/network
Benefits 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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
