Lead, QA Ops

3 days ago


Singapore Novartis Full time

More than 380 That’s the number of associates in our Singapore Large Molecules division to support the making of medicines for our patients worldwide.
- As a QA Lead, you will be 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.**Key Responsibilities**
- **Operational**
- 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 and QA Operational Excellence- **Leadership & Culture**
- 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 and 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- Create a work environment that enables high employee engagement
- Role model the culture aspiration of being Curious, Inspired and Un-bossed and ensure leaders and associates are aware and aligned on expectations and hold them accountable for success of culture journey- **HSE**
- 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.
- Guarantee the effectiveness of the Business Continuity Plan within area of responsibility
- Responsible for participating in initial training and retraining
- HSE incidents reporting & action follow-up**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**
- University degree with a scientific / technological background (e.g., Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
- 8 to 10 years of people management experience as will be involved in handling a large team
- Combination of experience in day-to-day operations such as handling deviation, CAPA, Batch release, new product introduction, tech transfer, process validation and cleaning validation
- Comfortable in customer interface, supplier management and negotiation, handling escalation
- Background in MS&T where involved in product validation and cleaning validation are also encouraged to apply
- Must have pharma industry/GMP background
- Functional Breadth; People Leadership; Organization Scope; Scale and Complexity; Collaborating across boundaries; Project Management

**Why consider Novartis?**
766 million lives were touched by Novartis medicines in 2021, 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**

**Division**
- Novartis Technical Operations

**Business Unit**
- QUALITY

**Country**
- Singapore

**Work Location**
- Singapore

**Company/Legal Entity**
- NOV SINGAPORE PHARMA MANUFG

**Functional Area**
- Quality

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No


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