Data Governance Analyst

Posting Date 2 months ago(8/5/2020 8:42 PM)
Requisition ID
2020-7248
Job Location(s)
Pittsburgh PA United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Information Technology

Overview

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.

 

For data integrity and data privacy related to computer systems and infrastructure, the Data Governance Analyst has responsibility for insuring accountability by system owners and process owners in meeting compliance objectives of the MyoSite 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.

Responsibilities

• For the IAMP, developing and continually improving the:

  - Policies, procedures, and vocabulary of the framework for the IAMP

  - Identification of MyoSite information asset (e.g. data and meta-data) ownership

  - For data, mapping the chain of custody, system of reference, and any secondary references

  - For data, identifying the lifecycle

  - Maintaining a MyoSite data resource inventory

• On a continuous basis, audit data integrity, data privacy, and data governance compliance for:

  - On premise computer systems and infrastructure

  - SaaS providers, hosted systems, and cloud computing

  - CROs and outsourced clinical sites

• For computer system data migration tasks, be responsible for authoring and execution of IQ, OQ, PQ and protocols to establish data integrity for the resulting system

• Initiate, coordinate and execute projects to ensure the successful completion of CSV activities

• Promote and educate business units about the IAMP

• Work closely with business unit leadership to continuously improve the use of strategic information assets with confidence

• Author policy documents, Business Operating Procedures (BOPs), and Standard Operating Procedures (SOPs) as necessary for compliance to the IAMP; maintain these documents

• 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

 

Qualifications

• Undergraduate degree in Computer Science, Information Science, IT, Bio Engineering, or any related field or 6 years direct, relevant experience in IT (Computer Systems) validation to provide a comparable background

• Minimum of 3-6 years’ as a project or technical lead preferred

• 3+ years of formal auditing or testing of computer systems and infrastructure preferred

• 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.

• Experience working in a regulated environment is preferred

• Experience in resolving issues of data quality, storage, protection and dissemination

• 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

 

Physical Requirements:

• Office Setting

• 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.

 

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed