Singapore Job Openings

Novartis

Lead, QSRC (Quality System Regulatory Compliance)

Tuas

FULL TIME

October 18, 2024

Summary

Responsible to ensure compliance to c Gx P standards for products within area of responsibility (during development, transfer and commercialization) and product release. Provide guidance, support and leadership to teams within area of responsibility.

About the Role

Key Responsibilities:

Ensure QC activities executed according to c Gx P standards. Collaboration in Gx P audits/inspections.
Oversight of Quality Operations across site. Inbound QA oversight. Outbound QA oversight
MBR review and approval. Product release. QA for Quality Control & AS & T. QA Operational Excellence.
Drives 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 responsibility
Invest time in personally developing and coaching talents.
Actively support and promote talent exchange for the benefit of the individuals and organization.
Ensure the consistency between career development processes and the business strategy
Support the T&L organization by identifying and reviewing the appropriate list of training for all in-scope associates
Ensure that associates are qualified for a GMP task prior to independent performance
Monitor overall training compliance for in-scope associates
Identify and maintain a list of subject matter experts for in-scope areas of expertise
Promote and improve the Safety and Quality cultures, by implementing the necessary systems and actions in line with the evolution of the site
Ensure overall inspection readiness for area of responsibility.

Essential Requirements:

Several years of experience (> 3 years) in the release of medicinal products for human use; several years of experience of leading a large team.
Functional Breadth; People Leadership; Organization Scope; Scale and Complexity; Collaborating across boundaries; Project Management.
Collaboration; result-oriented; problem-solving-oriented
Advanced communication skills; motivates colleagues and co-workers
Highly structured working style
Leadership and change management, objective setting and performance management
Budget management, Operational Excellence, Risk Management
Applied Business Insights, Project Excellence, Stakeholder Engagement, Organizational Savvy.
Expertise in Gx P operations; product release activities
Quality Assurance; Knowledge of GMP; Health Authorities; Supplier Relationship Management; Strategic thinking and planning; Quality. decision making
MS Office applications and other standard IT applications supporting Quality activities.

Desirable Requirements:

University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.

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

Division

Operations

Business Unit

Innovative Medicines

Location

Singapore

Site

Tuas South Avenue

Company / Legal Entity

SG12 (FCRS = SG012) Novartis Singapore Pharmaceutical Manufacturing Pte Ltd

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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