Greg Walker

About Greg Walker

Proven track record leading organizations and teams to accomplish ambitious and challenging goals while fostering an environment conducive to professional growth and career satisfaction. • Possess excellent interpersonal, project management, quality assurance, computer system validation, technical writing, auditing, and problem-solving skills, backed by 26 years of experience managing and executing quality/compliance projects in the biotech, pharmaceutical and medical device industries. • Demonstrated knowledge of FDA regulatory requirements, including GMP, GLP, GCP, Part 11, Annex 11 QSR, PDMA and industry best practices; knowledge of other relevant compliance requirements such as GDPR and SOX. • Subject matter expert in 21 CFR Part 11 regulations and Data Integrity best practices, having served numerous clients in strategic roles related to the interpretation, assessment and remediation of electronic record/electronic signature systems. • Experience in all aspects of the drug development life cycle including research, development, supply chain, marketing & pharmacovigilance. • 28 years of pharmaceutical industry experience managing and executing a variety of projects including computer system validations, compliance assessments, infrastructure qualification, compliance audits, risk assessment/mitigation, SOP development, and system integration. • Served in various quality roles including internal IT QA, QA auditor, external auditor, quality approver and project quality/compliance representative.

Experience

1. Global Head of Quality Management - Life Sciences

   NNIT

   Jan 2022 — Present · Princeton, NJ, US

Education

• Penn State University

  B.S.

  1989 — 2004

Skills

• Regulatory Affairs
• V
• Technical Writing
• Lifesciences
• Gxp
• Life Sciences
• Quality System
• Fda
• Computer System Validation
• Software Quality Assurance
• Pharmaceutical Industry
• Quality Assurance
• Change Control
• 21 Cfr Part 11
• Validation
• Sop
• Compliance
• Gmp
• Biotechnology