Lead, QSRC (Quality System Regulatory Compliance)

Summary

Responsible to ensure compliance to cGxP 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 cGxP standards. Collaboration in GxP 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 GxP 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
No