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Apply to JobJob ID251374BRPosition TitleProcess Control Manager in Global Development OperationsJob DescriptionGDO TM PCMs need you!! You will become an active contributor to the implementation of enhanced quality systems and standards within GDO Trial Management. Support the improvement in quality within GDO Trial Management by proactively identifying and addressing areas of concerns to avoid downstream issues. Assist the Global Head Clinical Trial Management Center of Excellence and the Global Head of Process Control Managers to drive a quality, compliance and quality process improvement mindset within GDO Trial Management.



YOUR RESPONSIBILITIES INCLUDE

• Reporting of KQIs, Standard Operating Procedures (SOP) deviations, QP deviations, etc to the Global Head Process Control Managers and Global Head Trial Management Center of Excellence as well as to associates in GDO Trial Management. Recommend corrective actions and ensure all relevant follow-up activities are completed based upon report outputs.

 • Follow-up to completion all relevant remedial strategies resulting from Corrective Action Plans identified during Audits and Inspections.

 • Represent GDO Trial Management on cross-functional initiatives aimed at process improvement and enhanced quality implementation of new processes.

 • Collaborate with QA and support GDO Trial Management associates to have Health Authority Inspections and Audits with no observations impacting GDO Trial Management. Ensure all corrective and preventive actions are implemented as they impact GDO Trial Management.

 • Review and provide input to SOPs as needed. Collaborate effectively with associates across the Division as applicable. Support operational aspects of implementing new or revised processes in GDO Trial Management to enhance clinical trial process quality.



YOU’LL RECEIVE:

Benefits you’ll receive include competitive salary and annual bonus, pension, 25+ days of annual holiday, Employee Share Option program, HQ campus facilities including restaurants/banking/gym/pharmacy/supermarket.Minimum requirementsWHAT YOU’LL BRING TO THE ROLE

 • Bachelor’s Life Science Degree. Advanced degree or equivalent education/degree in life science/healthcare preferred. Fluent English (oral and written)

 • At least 5 years working experience in Clinical Development and demonstrated experience in quality management, quality improvement, or GCP auditing.

 • Strong understanding of regulation and guidance for drug studies including: ICH guidelines on GCP (E6, E2A and E8) and applicable regulatory requirements, specifically 21CFR sub-parts 50, 54, 56, 312 and 314 as well as the European Directives on GCP (2001/20/EC and 2005/28/EC).

 • Experience leading or participating in process improvement initiatives.

 • Strong capacity for working independently with minimal guidance. Able to make & communicate difficult decisions

 • Strong skills to facilitate/ optimize contribution of team members as individuals and members of a cohesive team.



DESIRABLE REQUIREMENTS

 • Establish business partnerships with all relevant GDO Trial Management, QA, and other LFs as required.

 • Relevant knowledge of the internal processes and ICH regulations



WHY CONSIDER NOVARTIS?

927 million. That’s how many lives our products touched in 2017. 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.



We are Novartis. Join us and help us reimagine medicine.DivisionGlobal Drug DevelopmentBusiness UnitGDO GDDLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaQualityJob TypeFull TimeEmployment TypeRegular

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