Sunovion Pharmaceuticals is looking for Associate Director, Quality Assurance (QA) Computerized Systems to join our QA Organization in Marlborough, MA.
Provide QA oversight of computerized system validation activities for regional and global systems through periodic reviews and audits of a wide variety of hosted and on premise GxP systems.
Serve as QA SME in computer system validation, data integrity and electronic records and signatures for COTS systems used to support Sunovion GxP activities including GCP, GVP and GMP. Provide Computer System QA Support to CSV project teams.
* Perform QA review of CSV deliverables including validation plans, user requirements, executed test scripts and report
* Evaluate change controls for computerized systems to ensure adequate testing is performed
* Perform or oversee the conduct of CSV audits of internal computerized systems, computer software suppliers, hosted data centers and systems used by GxP providers.
* Manage the CSV audit program including the annual audit schedule, development of audit plans and reports, and tracking of CSV related CAPAs.
* Manage and maintain the periodic review system to assure computerized systems are maintained in a validated state and in compliance with applicable regulations and SOPs
* Develop and review related regional and global SOP
* Serve as the Sunovion CSV SME during audits and inspections by business partners and regulatory agencie
* Elevate critical and significant quality assurance and compliance issues to senior management.
Minimum Education, Experience, Knowledge and Skills Required
Education level and/or relevant experience(s):
* Minimum of Bachelor's degree in Computer Science or equivalent (Master's preferred)
* Minimum 8 years of experience auditing and reviewing computerized system validation activities for clinical, safety, laboratory and manufacturing computerized systems in an FDA regulated biotechnology, pharmaceutical or medical device company..
* Minimum 3 years management/leadership experience
Knowledge and skills (general and technical):
* Experienced with computer system validation in a variety of GXP areas including clinical development, pharmacovigilance, supply chain and quality.
* Thorough working knowledge of computer system validation, data integrity and electronic records and signature related regulations and industry best practices such as 21 CFR Part 11, Annex 11 and GAMP5.
* Understands system lifecycle management and can apply it using a risk based approach.
* Knowledgeable of GXP regulations particularly GCP, GVP and GMP.
* Able to work independently and with cross-functional project teams .
* Ability to think strategically while maintaining strong attention to detail.
* Strong written and oral communication skills.
* Good problem solving skills.
* Experienced with Microsoft products such as Word, Excel, Project, and Visio.
* May require some travel.
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.