[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