Job ID292682BRPosition TitleCompliance Excellence Officer – Pharmacokinetics (80-100%*)Apply to Job
Job Description
5600 scientists working on 340 discovery programs in 8 disease areas focusing on 90 new molecular entities makes Novartis a premier place to develop your career as a pharmaceutical professional. If you are curious, scientifically minded, detail oriented and want to positively impact society by speeding the delivery of novel therapies to patients, then look no further, NIBR is the place to be.
As a Compliance Excellence Officer (CEO) in the Translational Medicine Pharmacokinetic Sciences group, you will have the opportunity to make a difference. We are looking for professionals with expertise in bioanalytics, pharmacokinetics, and familiarity with quality & information management systems. The role is within NIBR at the Novartis Global Headquarters in Basel, Switzerland. If you have a collaborative nature, a commitment to teamwork and a focus on continuous improvement, we want you to apply. As a Compliance Excellence Officer, which is equivalent in level to a Principal Scientist, your responsibility will be to ensure the continuity of bioanalytical science through compliance and process excellence with scope spanning late discovery to post-marketing.
Your responsibilities will include but are not limited to:
• Support identification, overview and prioritisation of compliance improvement activities to enhance regulatory compliance within Global Bioanalytics.
• Identify areas of concerns/deficiencies and propose improvement or training.
• Lead the CRO oversight and governance in compliance with the Novartis SOPs.
• Collaborate with Quality Assurance and Bioanalytics Leadership Team to support preparation, conduct and follow up of audits and/or health authority inspections. Oversee preparation and completion of compliance deviation / Corrective Action Plans.
• Be the line function applicability representative for Standard Operating Procedures (SOP) assignment and coordinate SOP revision and other process documents.
• Maintain expertise in regulatory guidelines for ICH, FDA, and other Health Authorities (HA) whilst acting as a point of contact by providing consolidated feedback to HA on behalf of Global Bioanalytics.
Minimum requirements
What you’ll bring to the role:
• MS or PhD or equivalent in a relevant discipline
• Fluent English oral and written
• Significant experience relevant to this position in the pharmaceutical/CRO/related industry
• Strong scientific, process and operational background
• Fundamental understanding of bioanalytics and quality management systems and concepts
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
*Some restrictions on flexible working options may apply and will be discussed during interview if applicable.
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