Lead, Qsrc

1 week ago


Tuas, Singapore Novartis Full time

**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
- 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

**Desirable Requirements**:

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

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

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