IBM Watson Health - Compliance Program Specialist - Lead Auditor in CAMBRIDGE, Massachusetts
From launching patient-led studies to matching patients to clinical trials, and from matching families to services and benefits, to cancer and chronic disease management, Watson Health is working to transform health and wellness. It’s time to transform health with new ways of working to improve approaches to care, productivity and well-being. Watson Health’s cognitive systems understand, reason and learn – helping to translate information into knowledge that can help drive more informed decision-making.
Compliance Program Team Specialist (Lead Auditor) opportunities are currently available in Cambridge, MA; .
As member of the Compliance team, you will support the Watson Health solution teams. You will use your knowledge of FDA and EU MDD medical device compliance regulations, medical device industry standards, requirements for software development in Healthcare, and Compliance Operations Management to develop and deliver compliance audits, policies, procedures, tooling, and support. You will interface with the Business and Marketing leaders, the solution teams, regulatory experts in the compliance team, the legal department, and other stakeholders on a project basis and on an operational level to build, maintain and operate parts of the compliance program.
Additionally, you will:
Assist in the identification, implementation and maintenance of the program/organization’s policies and procedures.
Perform ongoing compliance monitoring activities.
Work with regulatory experts to ensure the practice/organization maintains appropriate documentation.
Implement and manage systems for Quality Management, Quality Assurance, and Data Governance.
Oversee, direct, deliver, or ensure delivery of training and orientation to all employees, volunteers, medical and professional staff and applicable business associates.
Coordinate inspections and audits by FDA, other regulatory agencies, WH’s commercial partners, and WH’s customers.
Plan and lead internal audits in support of the Watson Health Quality Management System.
Successful candidates will possess the following:
Knowledge and experience with software development in the Healthcare industry, software as a medical device (industry standards and regulations), and Privacy and Security regulations and standards.This includes but is not limited to GDPR, HIPAA, 21 CFR 820, 21 CFR Part 11, ISO 13485, ISO 14971, IEC62304, ISO 82304, and ISO 27001/27002
Experience in coordinating inspections and audits by FDA, other regulatory agencies, WH’s commercial partners, and WH’s customers.
Demonstrated organization, facilitation, communication, technical writing and presentation skills.
Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of moderate scope and complexity
Lead Audit experience and skills
With cognitive computing, we can see and analyze more data than ever before – and achieve more than we ever thought possible.
Required Technical and Professional Expertise
At least 3 years of lead auditing experience complying with a quality management system
At least 5 years of work experience in a medical device or pharmaceutical company
At least 2 years of work experience in a Healthcare software development company
At least 2 years of work experience in coordinating customer audits, regulatory inspections, and registrar audits
Preferred Tech and Prof Experience
5 years of internal auditing experience complying with a quality management system in healthcare regulated environments
7 years of work experience in a medical device or pharmaceutical company
3 years of work experience in a Healthcare software development company in the Cloud and Mobile platform industry segment
IBM is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. IBM is also committed to compliance with all fair employment practices regarding citizenship and immigration status.