Regulatory Compliance Manager

Location: Foster City, ca
Position: Regulatory Compliance Specialist - Electronic Systems
Location: Foster City
Position Type: Contract

Essential Duties and Job Functions:
  • Assist members of Electronic System Compliance in providing quality and compliance oversight for the computer system validation and the electronic records / electronic signatures compliance programs
  • Conduct electronic record and electronic signature assessments and assist the business areas and IT in developing corrective action plans
  • Work to ensure that up-to-date computer system inventories and assessments of regulated systems are maintained
  • Assist with CRO/service provider audits, audits of software vendors and in-house audits, any of which may require travel

Specific Knowledge and Skills Required:
  • Previous experience in the biotechnology / pharmaceutical or related industry implementing and validating computer systems that manage regulated information
  • Experienced in the validation of COTS and in-house developed computer systems
  • Experienced in prospective and retrospective computer system validation
  • Experienced in performing 21 CFR Part 11 and Annex 11 assessments (gap analyses) and developing corrective action plans
  • Knowledgeable with software development life cycles and other IT related development practices
  • Working knowledge of IT infrastructure qualification processes and IT operating procedures
  • Experienced in using, implementing, and/or validating systems, such as: drug safety, medical/drug coding, clinical trial management, clinical information, electronic data capture, electronic diary, radiological reading, laboratory information management, computerized laboratory instrumentation, document/enterprise content management, submission publishing, electronic transfer/exchange, structured product labeling, training records, CAPA, and audit tracking
  • Experienced in developing procedures for validation, electronic record and electronic signature compliance, electronic systems compliance, and/or IT operational procedures
  • Knowledgeable in 21 CFR Part 11, GCP, GLP, and GMP regulations
  • BS with 3 to 5 years of experience
  • MS with 2 years of experience
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