Job Description
IBM Watson Health is looking for talented individuals destined to usher in the next era of healthcare. We live in a moment of remarkable change and opportunity. The convergence of data and technology is transforming healthcare and life sciences organizations today. New opportunities are being created that never existed before to meet the demands of this transformation. We have an exciting opportunity for a QA & Compliance Manager to help us revolutionize how doctors research cancer and engage the quality of life in clinical patient care.
The QA & Compliance Manager will manage the regulatory compliance and quality assurance program for the new ‘GxP Compliant Cloud’ offering. The role will include compliance with both IBM internal policies and also with FDA and other regulatory requirements. Responsibilities of the position will include:
Managing activities to assure compliance with requirements and contract terms (system validation, document management, training records, etc)
Providing oversight and direction for quality management and regulatory compliance to delivery staff supporting the GxP Compliant Cloud
Participating on projects to develop new Life Sciences solutions, such as expanded scope of GxP Compliant Cloud
Managing relationships with the Life Sciences, offering DPE, and delivery performers
Reporting status, compliance risks, and quality issues to Cloud Delivery management
Preparing for and coordinating IBM’s response to customer or government audits of the GxP Compliant Cloud
Understanding GxP requirements, life science industry regulations, and contractual obligations related to the GxP Compliant Cloud
Mitigating risks, resolving issues, and remediating audit findings in a timely manner
Ability to demonstrate good verbal and written communication skills as well as be comfortable with presentations to executives. The ideal candidate will show strong leadership and project management abilities. Be knowledge of computer operating systems, middleware, and ERP applications and demonstrate proficiency with executive level presentations and status reporting. They must have tenacious at uncovering problems and developing solutions. Interested? Join us in leading the era of cognitive computing! Qualifications
At least 5 years’ experience in life science industry (pharmaceutical, biotechnology, medical device firm, contract research organization) and or Cloud Computing
At least Experience Implementing and administering a quality management system (QMS) for the Life Sciences, Pharmaceutical, Biotech, Medical Device or Contract Research industry
Demonstrated experience managing infrastructure qualification and/or system validation projects to meet Life Sciences regulatory requirements
Experience developing and overseeing regulatory training for quality assurance, delivery, and management personnel
Experience with developing and overseeing work instruction and SOP documentation for a regulated computing environment
Demonstrated responsibility of managing internal and external audits, addressing audit findings, and implementing corrective and preventative measures
Additional Information
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