Manager, Computer Systems Compliance - Marlborough, MA | Biospace
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Manager, Computer Systems Compliance

Sunovion Pharmaceuticals Inc.

Marlborough, MA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Hands on computer system validation position responsible for creating, managing and maintaining full validation deliverables for regional and global computer systems that support regulated clinical, pharmacovigilance, quality and commercial activities.
1. Define the scope and complexity of computerized system validation projects based on system and functional risk analyses.
2. Participate in project team meetings as required including early morning and/or evening teleconferences with global project teams.
3. Develop requirements for business requirements, system security, user roles, workflows, data flows, GxP regulations and how these systems fit into the larger IT infrastructure.
4. Create and/or review computer system validation schedules, risk assessments, requirement specifications, protocols and reports, test scripts, traceability matrices, and validation summary reports that utilize test strategies commensurate with regulatory risk. Review applicable procedures and system training manuals as applicable.
5. Work with IT and User Groups to: evaluate change control requests, assess regulatory risk associated with such requests and determine the corresponding validation requirements for such changes.
6. Conduct Part 11 and Computer System Validation compliance audits to ensure all computer systems used by Sunovion for GxP activities are maintained in a validated state and the validation documentation is adequate for regulatory inspection.


• Bachelors or Masters in Computer Science, Computer Information Systems, Information Technology or related discipline.
• 5-7 years computer system validation experience validating complex systems and writing CSV test scripts, protocols and summary reports

Knowledge and skills (general and technical):
• Knowledgeable of FDA/EU/MHLW Regulatory Requirements and industry best practices for computerized system validation
• Experience working with global teams is preferred
• Understands lifecycle approach as well as risk based approach to validation
• Familiar with GXP regulations for drugs and combination products particularly in the GCP and quality areas.
• Very familiar with Information Technology principles, functionalities and capabilities of computer systems; and how computer systems relate to and integrate with larger corporate IT infrastructures
• Able to work both independently and as a member of cross-functional project teams
• Ability to manage complex projects
• Strong written and oral communication skills
• Good problem solving skills
• Microsoft products such as Word, Excel, Project, and Visio.