DirecciónOracle Life Sciences is a leader in cloud technology, pharmaceutical research, and consulting, trusted globally by professionals in both large and emerging companies engaged in clinical research and pharmacovigilance, throughout the therapeutic development lifecycle, including pre- and post-drug launch activities.
With more than 20 years’ experience, Oracle Life Sciences is committed to supporting clinical development and leveraging real-world evidence to deliver innovation and accelerate advancements empowering the Life Sciences industry to help improve patient outcomes.
With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences and, with Cerner Enviza immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.
The main focus of the position of the Compliance & Quality Manager is to define policies and procedures (standard operating procedures (SOPs)) in close cooperation with the subject matter experts within the organization.
They are responsible for the administration and maintenance of the quality system, including SOPs and work instructions (WIs) and the administration of related SharePoint solutions and the archive (electronic and paper).
Further responsibility of a Compliance & Quality Manager is to develop, perform and manage all quality management (QM) related activities such as the preparation and coordination of external client audits.
They are responsible for the conduct of basic quality management trainings for new staff members as well as SOP trainings and tracks information on the participation in both external and mandatory internal trainings.
S / he maintains a trainings file for all staff members as required.
Together with the QA Manager, they are also responsible for implementing and monitoring the quality procedures in the respective unit as well as contributing to the development of the global Cerner Enviza quality management structures.
Qualifications :
- Solid quality management experience preferably in a pharmaceutical company or CRO
- Familiar with quality management systems
- Familiar with regulatory and ICH-GCP guidelines
- A good understanding of the healthcare and pharmaceutical sector
- A good understanding of the ISO 9001 and ISO 27001 norm as well as solid GDPR knowledge
- Solid experience in the conduct of external audits
- Embraces thought leadership to produce impactful deliverables
- Proven project leadership and management skills
At Oracle, we don’t just respect differences we celebrate them. We believe that innovation starts with inclusion and to create the future we need people with diverse backgrounds, perspectives, and abilities.
That’s why we’re committed to creating a workplace where all kinds of people can do their best work. It’s when everyone’s voice is heard and valued that we’re inspired to go beyond what’s been done before.
We expressly encourage disabled candidates to apply for this position. Please therefore feel free to voluntarily inform us in your application about any severe disability (degree of disability of at least 50%) or any equal status (degree of disability of at least 30% together with official decision on equality) in accordance with the German SGB IX.
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Performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and recommends appropriate changes.
Conducts and facilitates internal and external audits to identify, evaluate, disclose and appropriately remedy risks and deficiencies.
Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal and external audits and inspections.
May serve as point of contact for interactions with regulatory agencies for defined matters. Support the creation of a comprehensive risk management and regulatory oversight program, including specifications for product and service design aligned with Oracle Software Security Assurance and Security Architecture.
Review specifications. Develop training for GBU development, cloud services, services and operations teams on industry regulatory specifications applicable to their products and services.
Execute risk assessments and evaluate risks to the business and develop risk mitigation strategies. Work with members of GBU development, cloud services, services and operations teams to incorporate applicable industry regulatory standards, Oracle security policies and customer-contractual obligations into GBU processes and standards.
Coordinate industry and regulatory certifications, including managing certification vendors (., PCI, HIPAA,HITECH, ISO, SOC2).
Build security documentation and collateral for customers and internal users allowing security to be a differentiator in this GBUs.
Build management level metrics and reporting for activities that are owned by the Risk Manager. Execute a vendor security program.
