[Hiring] Senior / Principal Regulatory Compliance Consultant @Parexel

Role Description

The Senior / Principal Regulatory Compliance Consultant serves as a high-level subject matter expert in QC Microbiology and aseptic sterile drug product manufacturing. You will lead complex client engagements, provide hands-on technical and regulatory support, and drive sustainable quality and contamination control improvements.

This role requires up to 70% domestic and international travel to support client sites.

Key Responsibilities
• 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
• Build sustainable, risk-based programs that reduce deviations and contamination events

Qualifications
• 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

Preferred Qualifications
• Prior consulting experience
• Experience with facility startup, remediation, or major operational readiness efforts
• ASQ CQA or similar certification
• Experience preparing for and supporting FDA/EMA regulatory inspections
• Strong experience authoring technical or regulatory documentation

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