Sunovion Manager, Computer Systems Quality in Marlborough, Massachusetts
Sunovion Pharmaceuticals is looking for a Manager, Computer Systems Quality to join our Computer Systems Quality team in Marlborough, MA.
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.
Define the scope and complexity of computerized system validation projects based on system and functional risk analyses.
Participate in project team meetings as required including early morning and/or evening teleconferences with global project teams.
Develop requirements for business requirements, system security, user roles, workflows, data flows, GxP regulations and how these systems fit into the larger IT infrastructure.
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.
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.
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.
Minimum Education, Experience, Knowledge and Skills Required:
Bachelor's degree in Computer Science, Computer Information Systems, Information Technology or equivalent.
Minimum 5 years of experience validating complex systems and writing CSV test scripts, protocols and summary reports in an FDA regulated biotechnology, pharmaceutical or medical device company.
Knowledgeable of FDA/EU/MHLW Regulatory Requirements and industry best practices for computerized system validation.
Understands lifecycle approach and risk-based approach to validation.
Familiar with GXP regulations for drugs and combination products particularly in the GCP and quality areas.
Experience validating systems used to support GCP business processes preferred.
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. Experience working with global teams is preferred.
Ability to manage complex validation projects.
Strong written and oral communication skills.
Good problem-solving skills.
Experienced with Microsoft products such as Word, Excel, Project, and Visio.
Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer. Sunovion is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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