Parexel

Senior/Principal Regulatory Compliance Consultant

Parexel

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Senior

About the role

  • Serve as a trusted expert in: QC Microbiology operations and laboratory leadership
  • Aseptic processing and sterile drug manufacturing
  • Contamination Control Strategies (CCS)
  • Environmental Monitoring (EM) programs
  • Microbial identification, trending, investigations, and CAPA oversight
  • Water systems, cleaning/disinfection, and sterility assurance
  • Lead high-impact projects, including: Designing or optimizing EM, APS, AOQ, and CCS programs
  • Supporting facility expansions, lab startups, and method qualifications
  • Conducting regulatory readiness assessments and mock inspections
  • Authoring and reviewing SOPs, risk assessments (HACCP, FMEA), validation protocols, and technical documentation
  • Leading investigations using root cause analysis principles
  • Partner with client leadership to: Strengthen quality systems aligned with FDA, EMA, ICH, USP, and global standards
  • Coach microbiology and manufacturing teams on aseptic best practices
  • Drive compliance improvements that enhance operational reliability and inspection outcomes

Requirements

  • 10+ years QC Microbiology experience, including supervisory or managerial responsibility
  • Deep experience supporting aseptic manufacturing of sterile drug products
  • Expertise in EM, CCS, APS, water systems, sterility assurance, and microbiology lab operations
  • Strong working knowledge of global regulations (FDA 21 CFR 210/211, EMA Annex 1, ICH, USP)
  • Proven ability to lead investigations, CAPAs, risk assessments, and data trending
  • Excellent communication skills with the ability to influence and educate teams
  • Ability to travel up to 70% domestically and internationally
Benefits
  • A meaningful mission —improving patient safety across global manufacturing sites
  • High-impact work with major biopharma and sterile drug product companies
  • A culture of support, collaboration, and empathy —true to our “With Heart” value
  • Consulting development and mentorship , including structured support for those new to consulting
  • Flexibility —remote work when not on client site, plus variety in daily responsibilities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
QC Microbiologyaseptic processingsterile drug manufacturingContamination Control StrategiesEnvironmental Monitoringmicrobial identificationCAPA oversightrisk assessmentsroot cause analysisvalidation protocols
Soft Skills
leadershipcommunicationinfluencecoachingteam education