Job Description

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

Join us as the Development Quality Assurance Manager / Senior Manager where you will be providing quality assurance and compliance oversight to development and research functions, drive the oversight of quality management systems and initiatives, ensuring compliance with applicable health authority regulatory requirements (e.g., GCP, GLP, GMP, PV, IP) and Novartis procedures and quality standards. Role model good quality behaviors while promoting a culture of quality (e.g., right first time, etc.) to positively impact the non-quality stakeholders (e.g., NIBR, GDD). Develop, drive and/or support Quality plan initiatives in order to achieve organizational strategy, mission and vision.

Key Responsibilities

• Provide QA expertise and guidance to ensure compliance with requirement of the quality system are met, including implementation of quality risk-based and GxP-relevant process.
• Lead and manage a QA organization and/or quality project team and collaborate with business partners and other quality groups to ensure health authority and regulatory requirements are fully met.
• Translate functional QA strategy into applicable operational/compliance activities and support a risk-based implementation and execution of processes.
• Ensure quality and compliance gaps are addressed and executed for sustainability and implement strategic process improvement, including review of procedural updates, training, process improvement, effectiveness checks, etc. Monitor implementation of the Quality Plan and support inspection readiness activities, including participation in regulatory inspection preparation, management and follow-up.
• Support quality oversight/management of external service providers and IT systems supporting research and development activities and drive facilitation and follow-up of audits and inspections, and ensure development, implementation and completion of appropriate corrective and preventive measures for findings.
• Ensure timely escalation of deviation/incidents and provide quality oversight for deviations/incidents, including robust investigations, root cause analysis and corrective actions implementation. Contribute towards lessons learned based on audits, inspections, incidents, regulatory intelligence, effectiveness.
• GCP/PV risks proactively identified and effectively mitigated. CAPAs are holistic, on-time and prevent issue recurrence. Ensuring that Country(ies) are inspection ready at all times.
• The number and severity of GCP/PV issues identified during internal and external audits is minimized. No regulatory delays are encountered due to inefficient local GCP/PV system.

Minimum requirements

What you'll bring to the role

• Bachelor's Degree in Life Sciences or any relevant field.
• Excellent command of English language both verbal and written.
• Minimum 10 years of experience in the pharmaceutical industry with strong knowledge and expertise in clinical development, pharmacovigilance and GCP.
• Ability to collaborate and work in a culturally diverse organisation
• Having a resilient mindset, high agility, interpersonal savvy.

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!

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.

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

Functional Area

Quality

Division

Global Drug Development

Business Unit

QA GDD

Employment Type

Regular

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.

Shift Work

No

Early Talent

No