Quality Assurance Manager

Major accountabilities:

• Ensure that all aspects of the handling and distribution of pharmaceutical products in Korea comply with the requirements of the Novartis Corporate Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements.Ensure that a local Quality System and Standard Operating Procedures are in place for all GMP-related activities and that compliance with cGMP regulations is maintained through training and internal audits.
• Monitor Key Quality Indicators (KQIs) related to GMP/GDP activities to Country QA and assure that gaps are addressed appropriately in order to mitigate risk.
• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the country.
• Establish a good working relationship with Supply Chain Management (SCM), Regulatory Affairs (RA), and Business Franchises (BFs).
• Ensure that coordinated contact is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors) and Global Quality Assurance.Manage that all drug products are released to the market in accordance with both
• a) Korea Pharmaceutical Law and the related regulation and b) Novartis Corporate Quality Policies.
• Ensure that an effective Change Control process is in place
• Ensure quality oversight of third party and coordinate all required activities to guarantee that redressing, storage and/or distribution of Novartis products are in compliance with Novartis Standards.Ensure Country readiness for all GMP/GDP regulatory inspections, and prompt decision and actions of recall / Market action and internal escalation.
• Manage complaints, deviations, counterfeits, and product tampering according to the Novartis Corporate Quality Manual and local written procedures. Support / participate in NEM cases as required and ensure relevant CAPAs have been completed/closed.
• Ensure conduct of adequate training at the Country for all GMP and GDP related activities by defining, planning, and supporting training activities.
• Ensure that Self-inspection process is in place.
• Ensure local APQR MAH review is managed in compliance with local requirements.
• Ensurereportingandfollowupofallspontaneousadverseevents(AE)and technical complaints for all Novartis products according to respective SOP

Minimum Requirements:
 

• Min. 7 years of experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, production or a directly related area
• Pharmacist License holder
• In-depth knowledge and experience of local GxP regulations and international standards
• Strong project management skills with experience of leading cross-functional or cross-cultural teams
• Excellent interpersonal, communication and negotiation skills with ability to work effectively in a matrix environment
• Problem-solving skills with change agility and smart risk-taking

Commitment to Diversity and Inclusion:

Novartis is an Equal Opportunity Employer and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.