- Entry level
- No Education
- Salary to negotiate
817 million. That’s how many lives our products touched in 2018. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks. And where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help reimagine medicine
Your responsibilities include, but not limited to:
• Lead the development of a cross-divisional Quality Culture with high awareness on data integrity and close collaboration with Malaysia Country Business Partners and ensure a state of the art Country Quality Organization is in place to best support overall business strategy.
• Establish effective Quality oversight and ensure Quality Plan is implemented in Malaysia (namely for commercial batch release in compliance with Marketing Authorization, effective change control management, effective complaint management, effective risk assessment, effective Quality oversight for clinical studies and pharmacovigilance processes).
• Act as the company key point of contact for Health Authority Field Alert and drug shortage reporting for pharmaceutical products and thereby provide a link between supplying sites and the agency.
• Establish regular review and assessment of KQIs at Malaysia Quality Committee and Executive Committees.
• Lead the implementation of applicable Quality Standards and effective CAPA processes and ensure compliance with escalation processes in Malaysia Country Organization.
• Ensure that relevant SOPs are aligned to HA regulatory requirements.
• Deliver successful GxP regulatory inspections and internal audits of Malaysia Country Organization.
• Continuously engage in benchmarking with other industries, industry peers and actively engage across Countries in building proactive relationships with Health Authorities.
• Ensure timely delivery of all quality services, and ensure all aspects of team activities comply with cGMP, legal, regulatory requirements and Novartis Pharma corporate Quality Manual and Policies.
• Attract and develop talent in the organization supporting a diverse and inclusive culture. Ensure robust performance management to optimize productivity across the organization. Provide active mentoring and coaching of associates at all levels.
What you’ll bring to the role:
• Bachelor’s Degree or equivalent University Degree in a Scientific or Technology field (e.g. Chemistry, Pharmacy or other Life Science). Advanced Degree preferred
• Good written and spoken English with additional language(s) a plus
• More than 12 years of experience in Pharmaceutical Industry across Quality Commercial / Quality Operations / Manufacturing / Development.
• Strong skills in planning, develop, implement and evaluate marketing strategies for on-going and new products.
• Possess strong analytical, communication strategies and leadership collaborative skills
Competitive salary, annual bonus, medical care, health insurance, dental & optical care, career opportunities. Find out more about Novartis at https://www.novartis.com
Novartis is an equal opportunities employer and welcome applications from all suitably qualified persons.
Division Novartis Technical Operations
Business Unit NTO QUALITY
Site Petaling Jaya
Company/Legal Entity NOV MALAYSIA
Functional Area Quality
Job Type Full Time
Employment Type Regular
About the company
Novartis has a clear mission, focused strategy and strong culture, all of which we expect will support the creation of value over the long term for our company, our shareholders and society. We recognize that our business depends on the creativity, dedication and performance of our associates. We encourage associates to focus on achievement through collaboration and innovation.
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field.
Our company culture is guided by high ethical standards. Our values help guide the choices people make every day, and they define our culture and help us execute the Novartis strategy in line with our mission and vision.