Country Quality Head, Singapore

1 company That is the journey Novartis is on in its quest to extend and improve people’s lives through reimagining medicine.

We are currently pursuing the journey to become a trusted partner for business and society by ensuring full quality compliant, with capable & agile team. If you are interested and have all necessary skills to take our journey to the next level, and if you have strong passion to serve internal and external customers, then come join us as our Country Quality Head for Singapore You will be leading the QA function ensuring that all processes and procedures, tasks, responsibilities and projects are in compliance with all pharmaceutical laws, the Novartis Quality Manual and Policies as well as Industry Best Practices.

**Key Responsibilities**:

- Ensure all quality-relevant processes within Singapore Country Organization are compliant and that non-compliance is via corrective and preventive actions (CAPA).
- Provide Quality oversight and governance to ensure proactive compliance with Novartis and Health Authority GxP requirements, and to meet business expectations.
- Ensure that regulatory controls are in place in relevant process steps as well as adherence to GxP, any further legal and company internal regulations for manufacturing, control and distribution operations and to HSE guidelines and requirements.
- Ensure implementation of defined Key Quality Indicators in the area of responsibility to monitor on an ongoing basis that relevant processes are in control and compliant.
- Shares communication with local Health Authorities with the organisation, tracking and closing commitments on time.
- Communicate country specific requirements to the Region and headquarter organizations for all GXP areas and assess their implications for the compliance of existing processes and systems. Initiate remediation activities, as necessary, to ensure ongoing compliance.
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
- Prevent quality or regulatory non-compliance issues which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the financial performance of the company, as well as the company reputation.
- Drive cross-divisional standardization and efficiency gains through innovation and operational excellence projects.

**Commitment to Diversity & Inclusion**:

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

**Minimum requirements**

**What you’ll bring to the role**:

- Bachelor’s Degree or equivalent 4-Year University degree in a Scientific or Technology field such as Chemistry, Pharmacy or other Life Science. Advanced degree would be preferred.
- Prior experience in the development and implementation of Quality Management Systems incl. Compliance & Auditing and dealing with Health Authorities
- Experienced in Regulatory submissions and registration, Product Lifecycle and product portfolio management
- Solid understanding of GMP especially in CAPA Management and Quality Audit.
- Ability to handle quality metrics & issues.
- Leadership experience, good stakeholder management skills coupled with strong communications skills.
**Why consider Novartis?**769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying

**Imagine what you could do at Novartis**
**Commitment to Diversity & Inclusion**:Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

**Division**

Novartis Technical Operations

**Business Unit**

NTO QUALITY

**Country**

Singapore

**Work Location**

Singapore

**Company/Legal Entity**

NOV SINGAPORE

**Functional Area**

Quality

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No