Associate Director, Quality Assurance, Computerized SystemsApply Now
Location: Marlborough, Massachusetts 01752
Employment Type: Direct Hire
AD, Quality Assurance, Computerized Systems Validation
Summary of Responsibilities
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 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 reports.
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 SOPs
Serve as the CSV SME during audits and inspections by business partners and regulatory agencies
Elevate critical and significant quality assurance and compliance issues to senior management.
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..
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.
Chris is responsible for account management and recruiting for the Permanent team. He works with companies and job seekers to identify their needs, manage their expectations, and help find them a great fit.
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