Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.
The Computer System Validation Data Governance Analyst at Cook MyoSite Inc. is a critical team member of the Information Services (IS) department and will be a liaison between the technical team, quality departments, and process owners. For data integrity and data privacy related to computer systems and infrastructure, the CSV Data Governance Analyst has responsibility for ensuring system/process owners’ accountability to meet compliance objectives for the MyoSite Data Integrity Program. Within the MyoSite DI program, this role is responsible for the Information Asset Management Program (IAMP). The IAMP consists of policies and procedures designed to drive compliance to applicable regulatory standards, corporate standards, and best practices in the areas of data governance and data privacy. To support the Data Integrity program, the CSV Data Governance Analyst will participate in change management, computer system validation activities, and general data governance management to deliver and maintain validated systems. This is a remote role with occasional travel to Pittsburgh, PA for on-site support.
• Responsible for developing and continually improving the data integrity processes, policies, and procedures including:
o IAMP framework, procedures, and vocabulary
o Identification of MyoSite information assets, data, meta-data, and process ownership
o data mapping the chain of custody, system of reference, and any secondary references
o identifying data lifecycle with the associated systems
o maintaining a MyoSite data resource inventory
o Collaborating with the Operational Excellence Office to ensure process mapping and data mapping are aligned.
o Collaborating with System Architect to ensure system design meets DI compliance
• On a continuous basis, audit systems and providers for data integrity, data privacy, and data governance compliance for:
o On premise computer systems and infrastructure
o SaaS providers, hosted systems, and cloud computing
o CROs and outsourced clinical sites
• Review audit responses and ensure system implementation/support meet policies and procedures.
• Responsible for planning and executing data migration and verification activities including authoring, and execution of CSV protocols to establish and maintain data integrity.
• Mentoring and coaching IS department and business resources to ensure adequate system design qualification. Initiate, coordinate, and execute projects to ensure the successful completion of CSV activities.
• Promote and educate business units about data integrity for computerized systems and the IAMP.
• Work closely with business unit leadership to continuously improve the use of strategic information assets with confidence.
• Develop/maintain policy and procedures for data integrity compliance and IAMP governance.
• Must maintain company quality and safety standards.
• Practice and stay current with ISPE GAMP best practices, biologics regulations, Parenteral Drug Association (PDA), United States Pharmacopeia (USP), and applicable ISO standards.
• Maintain professional and technical knowledge by attending educational workshops; benchmarking state-of-the-art practices; participating in professional societies.
• Maintain frequent communication with Information Services staff (CSA, QA, IT) process and system owners, and other support functions.
• Undergraduate degree in Computer Science, Information Science, IT, Bio Engineering, or any related field or 10 years direct, relevant experience in IT (Computer Systems) and validation to provide a comparable background.
• Minimum of 3-6 years’ as a project or technical lead and 3+ years of formal auditing or testing of computer systems and infrastructure.
• Experience working in a regulated environment is strongly preferred.
• Experience in resolving issues of data quality, storage, protection and dissemination.
• Experience working in a regulated environment is preferred.
• Ability to demonstrate strong knowledge of data governance best practices.
• Ability to demonstrate sound knowledge of privacy standards and associated regulatory requirements.
• Demonstrable ability to influence stakeholders and work closely with them to determine acceptable solutions.
• Ability to demonstrate problem-solving skills and ability to work in both collaborative and independent work situations.
• Ability to demonstrate exceptional analytical and conceptual thinking skills.
• Proficient knowledge of Microsoft Office software, and other general office equipment.
• In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP).
• Up-to-date with changes in technology and the business implications/applications of new technologies.
• Ability to learn and support new systems and applications, and the ability to provide technical training to end users.
• Setting (Remote): When working remotely, the expectation for the employee's travel time to our Pittsburgh, PA site should be typically less than 5-6 hours, with the maximum being 24 hours. This travel will support on-site situations such as operational emergencies, physical testing/configuration of systems/equipment, or the occasional training.
• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.